MINISTRY OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN
NATIONAL CENTRE FOR PROBLEMS OF TUBERCULOSIS
MANUAL
TB control
IN THE REPUBLIC OF KAZAKHSTAN
Almaty, 2008
2
CONTENTS
№ Pp.
Table of contents 2
Preface 7
Team of authors 8
Abbreviations 10
1. Strategy and organization of the National Programme for Control
tuberculosis in Kazakhstan. Ismailov Sh.Sh., Baymuhanova KH
Nazirova NI, ZI No
13
1.1 The purpose of TB control in Kazakhstan
1.2 International Strategy for TB control recommended by
WHO
1.3 Organization of the National Programme for Control of Tuberculosis in RK
1.4 Integrating SPE into the overall health system
1.5 Indicators GMP
2. Definition of cases and categories of treatment. Smailova GA, Aden, MM 18
2.1 The purpose of determining and factors affecting their classification
2.2. Localization of TB
2.3 Information about previously using TB treatment
2.4 The results of microscopic examination
2.5 The severity of disease
2.6 Categories of cases for registration (types of patients)
2.7 Categories and medication regimes
2.8 Results of the treatment (definitions for reporting)
3. Laboratory Service. Bismilda VL, Toksanbaeva B., Park M. 22
3.1 Organizational Structure
3.2 Organization of the microscopic and laboratory use
Equipment
3.3 Preparation of smears
3.4 Preparation of reagents for staining by Ziehl-Neelsen
3.5 Investigation under the microscope
3.6 Fluorescent Microscopy
3.7 Quality control of smear Research
3.8 Neurotoxin methods for isolating Office
3.9 Quality control of bacteriological laboratories
4. Tuberculosis of the lungs. Ismailov Sh.Sh., Smailova GA, Aden, MM, No ZI 39
4.1 Methods of detection of tuberculosis
4.2 Clinical signs
4.3 Diagnostics (diagnostic algorithm)
4.4 Clinical classification of tuberculosis
5. Extrapulmonary tuberculosis. Tutkyshbaev SO, No ZI, Zhumash TA,
Iserkepova JS
43
3
5.1 Identification and diagnosis of extrapulmonary tuberculosis
5.2 The main clinical forms of extrapulmonary TB
5.2.1 Tuberculous meningitis
5.2.2. Tuberculous pleurisy
5.2.3 Tuberculosis of bones and joints
5.2.4 Tuberculosis of peripheral lymph nodes
5.2.5 abdominal tuberculosis
5.2.6 Tuberculosis of the urinary system
5.2.7 Tuberculosis male urogenital
5.2.8 Tuberculosis genital organs of women
5.2.9 Tuberculosis of eye
5.2.10 Tuberculous pericarditis
5.2.11 Tuberculosis skin
6. Tuberculosis in children. Rakisheva AS, Serikbayev KS 57
6.1 Risk factors for tuberculosis in children
6.2 Clinical signs of TB in children
6.3 Identification and diagnosis of tuberculosis in children
6.4 Treatment of tuberculosis in children
7. Treatment of tuberculosis. Ismailov Sh.Sh., Smailova GA, Aden, MM, No ZI,
Erimbetov KD, Chaymerdenov S.Sh.
65
7.1 Basic principles of chemotherapy
7.2 Aims of treatment
7.3 The main anti-TB drugs, mechanism of action
7.4 Side effects of antituberculosis drugs and their introduction
7.5 Categories of treatment, prescribing scheme
7.6 The control (monitoring) of treatment
7.7 Cohort analysis of the TB program
7.8 Surgical and kollapsoterapevticheskie treatment
7.9 Pathogenetic treatment
Activities to identify and return lost touch with patients on treatment
8. Managing Medicines Facility
drugs. Mahmatov MM, Musabekova GA
89
8.1 Purpose and objectives
8.3 Organization of Medicines Management software
8.4 Methods for determination of drug needs
8.5 Managing the assessment of drug demand
8.6 Monitoring
9. Tuberculosis and HIV / AIDS Seledtzov VP, Markabaeva TA 116
9.1. Detection of TB in HIV - infected persons
9.2 The course of tuberculosis in HIV - infected persons and the difficulties
differential diagnosis
9.3 Registration of cases of tuberculosis in HIV - infected persons. Production
registered in the TB dispensaries.
9.4 Treatment of tuberculosis in HIV - infected patients and monitoring
treatment
4
9.5 Recommendations for prophylactic use of cotrimoxazole
9.6 Recommendations for the use of drugs with glucocorticoids
TB in combination with HIV 9.7 Clinical supervision for tuberculosis patients and persons
borne tuberculosis in the presence of concomitant HIV - infection
9.8 Identification of HIV - infection in TB patients
9.9 Antiretroviral therapy of HIV - infection in patients with concomitant
Tuberculosis
9.10 Specific prevention of tuberculosis in HIV - infected persons
10. The system of registration and reporting. Ismailov Sh.Sh., Tursynbaeva AS 135
10.1 The records
10.2 Reports Documentation
11. Prevention of tuberculosis. Serikbayev KS, Rakisheva AS, Tursynbaeva
AS
143
11.1 BCG vaccination and revaccination
11.2 Chemoprophylaxis
11.3 Indications for the direction of children in tuberculosis sanatorium
agencies
11.4 Sanitary prophylaxis
12. Health education and social mobilization for tuberculosis.
Belova ES, Usembaeva SA, Kolokina RS
163
12.1 The purpose and objectives of health education
12.3 Organizational Structure
12.4 The main directions of health education
12.5 Commitment to TB treatment
12.6 Methods of promotion and health education
12.7 Monitoring and Evaluation of AB
13. The strategy of infection control of tuberculosis. Musabekova GA
AT Kurbanov
170
13.1 Purpose and objectives
13.2 Definitions
13.3 The current system of infectious hospital
13.4 Organization of infection control
13.5 Service Control Infection Control
14. Organization of dispensary in tuberculosis
institutions. Baymuhanova KH, Hauadamova GT
178
14.1 dispensary group and observation
14.2 Criteria for activity of tuberculous process
14.3 High-risk groups for tuberculosis
14.4 The procedure for admission to work and study people who had suffered from tuberculosis
15. Interagency collaboration in TB control program.
Ismailov Sh.Sh., NazirovaN.I., Zhumadilova ZB, AT Kurbanov,
Zhandauletova Zh.T.
183
5
15.1 Basic principles of detection, diagnosis, treatment and prevention
tuberculosis at the organizational level PHC network
15.2 The role of organization of sanitary-epidemiological supervision of tuberculosis
15.3 Tuberculosis control in prisons
16. Monitoring and evaluation of programs to control TB.
Ismailov Sh.Sh., Zhandauletova Zh.T., AT Kurbanov
200
16.1 Purpose, objectives and methods of monitoring and evaluation system
16.2 Methodological principles of monitoring and evaluation
16.3 indicators (indicators)
16.4 Methods of monitoring and monitoring aspects of TB programs
16.5 Organizational structure and levels of monitoring and evaluation of TB
services in Kazakhstan
16.6 Organization, form and frequency of M & E
16.7 Planning, organization and logistics
monitoring visit
16.8 Training of Specialists on Monitoring
17. APPENDICES 213
№ 1 Situation of the focal points of the National TB
Program RK
Responsibilities of national coordinators
The functional responsibilities of regional coordinators
The functional responsibilities of the coordinators for tuberculosis CIPO MJ RK
№ 2 Checklist of activities for drug provision TAP
Leadership for the National Programme
№ 3 Glossary of terms and use the section "Management of Medicines
provision in the national TB program "
№ 4 roadmaps for interagency cooperation
№ 5 Format of lists of patients released from correctional
CIPO MJ RK
№ 6 Measures taken during breaks in treatment
№ 7 Groups dispensary and monitoring contingent
TB dispensaries
№ 8 Medical hospital record (medical history) Form 003 / y
№ 9 Vypisnoy epicrisis
№ 10 Features of the history of the disease surgical departments
№ 11 How to fill out-patient card (Form 025 / y)
№ 12 Rules for autopsy
№ 13 of the centralized medical-advisory committee
№ 14 Sample topics of lectures and discussions on health education
№ 15 transcripts
"Detection and diagnosis of tuberculosis"
"Compliance with the protocol sputum"
"Microscopic examination of sputum"
"Drug Management"
"Compliance with the protocol directly supervised treatment"
"Treatment and cohort analysis"
№ 16 log of persons on further examination (flyuoropolozhitelnyh persons).
6
№ 17 Instructions for the preparation of smears (by Ziehl-Neelsen)
№ 18 Minutes for the drug susceptibility of mycobacteria
TB
18. REFERENCES 270
The purpose of the Guidelines - to ensure the national TB program in
Kazakhstan, a practical guide to organizing the struggle against tuberculosis
based on the laws and regulations (Government Resolution,
Order of the MOH's and other agencies) documents, international recommendations and
experience of GMP synthesis NTSPT MH RK when running the program in the country during
10.
April 23, 2007 entered into force on the order of the RK Ministry of Health on improving the activities
Tuberculosis in the Republic of Kazakhstan ", which establishes mandatory
principles of TB control in the country. Guide contains
information on all components of the NNP and is aimed at quality performance
order.
The manual is intended for psychiatrists, doctors, primary care, general medical service,
nurses and professional services of sanitary-epidemiological surveillance and
administrators responsible for organizing and providing health services
population.
We express our deep gratitude to the Head of the WHO Regional Office in the CAR,
Dr. G. Tsogt for assisting in the writing of management and editing.
We express our heartfelt gratitude to all authors who contributed to
the process of creating leadership and its final result.
We express our deep appreciation to the reviewers:
- Director of the National TB Center of the Ministry of Health
Kyrgyz Republic, Professor Alisherovu AS
- Professor Phthisiopneumology Almaty Institute
Advanced Medical Naubetyarovoy AN
8
Composite authors
Editor in chief
Ismailov Shahimurat Shaimovich - Doctor of Medical Sciences, Professor, Director
National Centre for problems of tuberculosis of the Ministry of Health
Republic of Kazakhstan
Editorial Board:
Nazirova Nurhan Ibrayhanovna - Head of PHC facilities
Department of preventive and curative work of the Ministry of Health
Republic of Kazakhstan
Neither Zoya Ivanovna - PhD, Associate Professor
Aden Malik Moldabekovich - PhD, chief physician
National Centre for problems of tuberculosis of the Ministry of Health
Republic of Kazakhstan
Authors:
1. Aden MM - PhD, chief physician NTSPT RK
2. Baymuhanova KH - PhD, Head of
organization and planning of TB control activities NTSPT RK
3. Belova ES - Doctor of Medical Sciences, professor, deputy director of
NTSPT RK Science
4. Bismilda VL - PhD, Head of bacteriological
Laboratory NTSPT RK
5. Erimbetov KD - MD, Associate Professor, Senior Researcher
employee groups to develop effective treatments of patients
drug-resistant forms of tuberculosis NTSPT RK
6. Iserkepova JS - Ophthalmologist receiving and consulting department
NTSPT RK
7. Zhandauletova Zh.T. - Monitoring Specialist Group of the Project
Global Fund
8. Zhumash TA - PhD, Head of the urogenital
Department NTSPT RK
9. Zhumadilova ZB - Head of zoonotic and quarantine infekitsy
Committee SEN MH RK
10. Zholshorinov A.Zh. - Head of the Committee SEN MH RK
11. Ismailov Sh.Sh. - Doctor of Medical Sciences, Professor, Director NTSPT RK
12. Kolokina RS - Head of prevention of socially significant
diseases NTSPFZOZH
13. AT Kurbanov - Coordinator of the monitoring group NTSPT RK
14. Mahmatov MM - Medical Consultant
15. Musabekova GA - PhD, Senior Researcher
department for organizing and planning TB control activities,
coordinator of the monitoring group NTSPT RK
9
16. Nazirova NI - Head of Organization Department of the PHC medical
preventive work Ministry of Health
Kazakhstan
17. Neither ZI - PhD, associate
18. Rakisheva AS - MD, PhD, Department of
Phthisiopneumology KazNMU them. SD Asfendiyarova
19. Seledtzov VP - PhD, Associate Professor
Phthisiopneumology AGIUV
20. Serikbayev KS - PhD, Head Office
pulmonary tuberculosis for children and adolescents NTSPT RK
21. Smailova GA - Doctor of Medical Sciences, Professor, Head Office
for the treatment of patients with newly diagnosed tuberculosis
22. Toksanbaeva BA - Coordinator Laboratory Project HOPE / Kazakhstan
23. Tursynbaeva AS - Researcher of the organization and planning
TB activities NTSPT RK
24. Tutkyshbaev SO - PhD, Head of osteosurgical department NTSPT RK
25. Usembaeva SA - Fellow of the development of effective schemes
treatment of patients with drug-resistant forms of tuberculosis NTSPT RK
26. Hauadamova GT - - Doctor of Medical Sciences, Professor, Head
department for treatment of patients with disseminated forms of tuberculosis
NTSPT RK
27. Chaymerdenov S.Sh. - MD, Head of pulmonary
surgical department NTSPT RK
10
Abbreviations
BPO - antibacterial drugs
ALT - alanine
ART - antiretroviral therapy
AST - aspartate aminotransferase
BCG - vaccine bacillus Calmette-Guerin
BSHB - biological safety cabinet
HAI - hospital infection
HIV - Human Immunodeficiency Virus
VLT - extrapulmonary tuberculosis
WHO - World Health Organization
SFF - World Drug Facility
GMO UKUIS - Medical Support Unit of the Office
Committee of the correctional system
GPTD - City TB Dispensary
DIA - Department of the Interior
CLE - Department of Health
DNA - deoxyribonucleic acid
DOT or NKL - Directly Observed Treatment
DOTS - the international strategy for TB control recommended by
WHO
Healthy Lifestyle - Healthy Lifestyle
IVS - a temporary detention facility
CF - Correctional Facility
ELISA - enzyme immunoassay
IC - Infection control
IOM - information and educational materials
FDC - Combined fixed-dose
CIPO - Committee penal system
AFB - acid-fast bacilli
KIZ - a study of infectious diseases
CIC - Infection Control Committee
KP - a colony settlement
Nk - Wednesday Lowenstein-Jensen
LO - drug provision
LPO - Treatment and prevention organization
DM - medical-preventive work
Kazakh Interior Ministry - the Ministry of Internal Affairs of the Republic of Kazakhstan
MLSP RK - Ministry of Labour and Social Protection
MLS - places of detention
Medical Unit - Medical-Sanitary Unit
MBT - MBT
Ministry of Health of the Republic of Kazakhstan - Ministry of Health of the Republic of Kazakhstan
MSEC - medical-social expert commission
ICC - Monitoring training planning
MJ RK - Ministry of Justice of the Republic of Kazakhstan
11
M & E - Monitoring and evaluation
NPP - National TB Programme
NTSPFZOZH - National Centre for problems of healthy
Lifestyle
NTSPT Kazakhstan - National Center for Problems of tuberculosis
Kazakhstan
OPTD - the regional TB dispensary
OLS - general medical network
HMO UKUIS - Division (Department) Medical Support
Management Committee of the correctional
systems
ORiKT - Department of radiology and computed tomography
SWR - second-line drugs
TAP - TB drugs
PPW - quality assurance program for drug
PHC - Primary health care
VET - TB organization
PCR - polymerase chain reaction
RNA - ribonucleic acid
RPTD - Regional TB Dispensary
Media - media
AB - Health education
PTDC - remand
SES - Sanitary-Epidemiological Station
SEN - sanitary-epidemiological supervision
AIDS - acquired immunodeficiency syndrome
TB - tuberculosis
TBMLU - multidrug
resistance
TE - tuberculin unit
DST - DST
TRG - thematic sub-working group
TPLU - Tuberculosis of peripheral lymph nodes
Ulo - Medicines management software
UMO CIPO - Management Medical Support Committee
penitentiary
MIS - criminal-executive system
Parole - parole
UGSEN - management of public sanitation
Surveillance
Ultrasound - ultrasound
UKUIS MJ RK - Management Committee of the correctional
of the Ministry of Justice of the Republic of Kazakhstan
UV - ultraviolet radiation
TSLO - a series of drug supply
TSVKK - centralized medical-advisory committee
12
TL - Method Ziehl-Nielsen
BCG-(Bacillus Calmette Guerin)
- BCG
PPD-L 2m - purified protein derivative in Linnikovoy
standard dilution
MDR-TB (MDR TB multi-drug resistant
tuberculosis)
- Multidrug
resistance
FEFO - the principle of consumption of drugs in order of expiry
expiry date
XDR-TB (extensively
resistant tuberculosis)
- XDR-TB (XDR-TB
resistant)
1. STRATEGY AND ORGANIZATION OF THE NATIONAL PROGRAMME
TUBERCULOSIS CONTROL IN THE REPUBLIC OF KAZAKHSTAN
1.1 The purpose of TB control in Kazakhstan
Decrease the spread of tuberculosis infection through early detection
tuberculosis patients excreting Mycobacterium tuberculosis and qualitative
treatment of patients with all forms of tuberculosis.
1.2 International Strategy for TB control recommended by WHO
The present statistics from the WHO indicates continuing high burden of TB on
planet:
• 2 billion people, which is equal to 1 / 3 of the population across the globe are infected
Mycobacterium tuberculosis (MBT).
• 1 out of 10 infected with MTB during the life becomes ill active form
TB
• People with HIV are at increased risk.
• TB - contagious disease and if untreated, each patient an active
TB, which distinguishes Office, annually infects an average of 10 to 15 people.
• multidrug-resistant (TBMLU)
is present in virtually all 109 countries recently surveyed by WHO and
partners.
• Presumably, there is an annual 450 000 new cases TBMLU, and
the highest recorded in the former Soviet Union and China.
• Despite the fact that TB is curable, it kills 5000 daily life on the planet.
Mainly, TB affects the most vulnerable: the poor and
individuals with poor nutrition. Virtually all cases of TB deaths occur in
developing countries, affecting more young troops in the most
productive years. TB - the leading cause of mortality among HIVinfected people.
The reasons for slow progress in the fight against tuberculosis, by definition,
Special Committee on the epidemic of TB by WHO, is the lack
sufficient political will, and inefficient use of scarce in
most countries, financial resources, understaffing and
development of human resources, organizational problems of the health system, and
irregular provision of anti-TB drugs, in some cases,
unknown quality, and lack and lack of reliable rastrostranenie
Information about tuberculosis among the general population.
In 2000. Governments of 22 countries with the highest burden of TB signed
Amsterdam Declaration to Stop TB "on the joint fight against this scourge,
combining the technical partners, funding agencies and civil society.
However, the priority given to achieving the global goals of TB control was
considered in the context of how TB control will contribute to the overall objective
strengthen health systems. The first forum of partners of the Stop TB
14
held in Washington in October 2001, where he was declared the first Global Plan
within the Stop TB Partnership, which has two objectives: 1). by 2005
bring the identification of bacillary forms of TB to 70%, and 2). to cure 85% of them. In
the March 2004 New Delhi at the second forum, developed a strategy for the Partnership
"Stop TB" for achieving the Millennium Development Goals by 2015 - to reduce
prevalence of TB deaths by 50% compared with 1990 and 2050: to eliminate
TB as a public health problem (less than 1 case per 1 million population).
At the Group of Eight summit, held in Okinawa (April, 2001.) Were
made specific proposals on the financial support of public
Health in the fight against the three diseases - AIDS, Tuberculosis and
Malaria. In 2002, under the auspices of the UN and other international organizations was
organized by the Global Fund to Fight AIDS, TB and Malaria - GFATM. At
Tuberculosis Programme in Central Asia, the Global Fund has allocated 52.7 million
dollars. Kazakhstan has received a grant in 2006. for $ 9.8 million for
TB control activities. Global Fund aimed at
strengthening the national program for tuberculosis, as well as the treatment of patients with
MDR.
In 2005, the World Health Assembly the newly announced two key
order to control TB - is revealing, at least 70% of infectious patients (in
2005 this figure amounted to - 48%) and cure 85% of newly diagnosed
bacillary TB patients (according to 2004. - 82%). To achieve these goals was
before the current international strategy to Stop TB,
based on the principles of the DOTS strategy, which consists of the following
key components:
1. High-quality DOTS expansion and enhancement
Yes. Political commitment with increased and sustained
Financing
b.. Case detection through bacteriology
quality-assured
in. Standard treatment with supervision and support to
patients
The effective supply and management of medicines
e. Monitoring and evaluation system, including the quantification
treatment results
In addition, the strategy of "Stop TB" were added following
extremely important components:
2. Fighting HIV-related TB, MDR-TB
3. Promotion of health systems
4. Involvement of all health care providers (cooperation between
governmental organizations and the private sector)
5. Empowering people with TB and society (education
work and social mobilization)
6. Support and development of scientific research
To implement the strategic plan, the international community should address the following
tasks:
15
• Achieve universal access to high quality diagnosis and
treatment, patient-centered.
• Reduce the human suffering from socio-economic burden
associated with TB.
• Protect the poor and vulnerable populations from TB, TB / HIV and MDR-TB.
• Support the development of new tools to combat all forms of tuberculosis
and enable their timely and effective use.
1.3 Organization of the National Programme for Control of Tuberculosis in RK
National Programme for Tuberculosis Control in the Republic of Kazakhstan carried out on
state level and integrated into the national health system for
achieve effective screening and treatment of tuberculosis patients and
prevent the spread of infection.
The National Programme for Tuberculosis Control in the Republic of Kazakhstan is guided by
following policy documents:
1. Presidential Decree of November 16, 1998 № 4556 "State Program
health of the people "(with additions and modifications)
2. Presidential Decree № 3956 of 18 May 1998 with amendments on
Immediate measures to improve the health of citizens of the Republic
Kazakhstan "
3. Government Resolution № 839 "On urgent measures of protection
populations from TB in Kazakhstan "(with additions and modifications)
4. "State program of reforming and development of health
2005-2010gg "
5. Government Resolution № 1263 of December 21, 2007 "On Measures
protect the population from tuberculosis in the Republic of Kazakhstan "
The main directions of the National Programme for Control of TB in Kazakhstan:
1. provision of advice, organizational and methodological assistance to VET
provincial, municipal and district levels, health organizations of the common
medical network and departments of the Ministry of Justice of the Republic of Kazakhstan
(hereinafter MOJ), Ministry of Defence of the Republic of Kazakhstan (hereinafter - MOE), Ministry of
Interior of the Republic of Kazakhstan (hereinafter - the Ministry of Internal Affairs)
2. exercise control in determining the need for antidrugs for the treatment and prevention of tuberculosis, on their management
use, target expenditure and proper storage of the country
3. continuous supply of high quality TPE and access to
qualitative bacteriological diagnosis of TB
4. monitoring of TB activities in the areas
regions and rayschnnom level according to a schedule approved by the
authorized body
5. organizing and conducting trainings, seminars and conferences for professionals
phthisiatric service agencies GKSEN civil sector agencies MJ,
Defense, the Interior Ministry and the PHC network in the fight against tuberculosis
6. work with non-governmental organizations, including public and
international
16
Performing GMP shall have the following anti-organization:
� state institution "National Center for Tuberculosis Problems," MH
RK (NTSPT), the central body RPE
� TB dispensaries (regional and municipal levels)
� TB hospital (city and district levels)
� TB department (district level)
� for confirming the TB offices (district level)
� Specialised TB sanatorium (Republican,
provincial, municipal levels)
1.3.1 Functions of RPE at the national (central) level
• Strategic planning TB control activities in the country;
• Coordination of activities to improve the epidemiological situation
TB in Kazakhstan
• Reliable high-quality anti-TB Program
drugs, laboratory and medical equipment, monitoring
use and consumption
• Monitoring the implementation of all components of TB
activities in the republic (clinic, laboratory services, drug
software, information management and reporting, health education);
• Management of scientific and medical practitioners phthisiatric
Service of the Republic
• Conduct peer review implementation of the National
TB program at all levels
• Training and development strategy for human resource development in
TB Program
1.3.2 Functions of RPE at the regional (provincial / municipal and district) level
The activities of the TB program at the regional level is determined
and monitored the national level and provincial (municipal) and
district TB organizations (PTO).
Main function of the regional TB program is
control over the process of identifying and treating TB patients. Analysis, Planning and
coordination should facilitate the provision of quality
health services provided by PTI, which include the following:
a) Identification of tuberculosis:
• Identifying persons with suspected tuberculosis and their direction on the diagnostics
• Active screening of risk groups
• contact tracing
b) Maintenance of TB cases:
• Diagnosis and choice of appropriate treatment regimen for all cases
diagnosed tuberculosis
• Organization and administration of treatment under the direct supervision
• Registration and reporting
17
The National Programme for TB control can achieve its goals
only with the active work and interaction between soyuboy all its levels.
According to the WHO definition is "effective working national program to combat
Tuberculosis is making a high rate of recovery of patients, low
level of acquired drug resistance and, ultimately, high
detection rate of TB cases.
1.4 Integrating SPE into the overall health system
One way of guaranteeing long-term control of tuberculosis in the country,
is the integration of the national TB program in general
health care system, which gives patients access to free TB
diagnosis and treatment. Guide NTSPT RK, as the central management body
PNP should facilitate the development strategy of integration into
health, developing the following documents:
Yes. Guide to GMP, which includes technical guidance on GMP (general
Information about tuberculosis, the case definition and classification of disease
identification of cases, the procedure of treatment, etc.)
b.. Operational Guidelines for the NPP - description of staff units for all
levels, job descriptions, monitoring activities and laboratory
Research
in. Planning for a detailed budget, funding sources and responsibilities
The training program, the TB control activities at all levels
e. Organization of laboratory services
e. The system of registration and reporting using standardized
Register
Well. Monitoring and Evaluation Plan - allocation of responsibilities at different
levels
r. Plan for and supply, including the procurement of medicines
drugs and diagnostic materials
1.5 Indicators GMP
Indicators determined by the PNP leaders (managers) Program and
focus on WHO recommendations. To estimate the NPP, the following
Indicators:
• Availability of the National Tuberculosis Programme in Kazakhstan
• Index izlechivaemosti new smear-positive cases (with TBMLU
and without TBMLU)
• Proportion of newly diagnosed smear pulmonary tuberculosis
• The death rate from tuberculosis
2. DEFINITION OF CASES AND CATEGORY TB TREATMENT
2.1 The purpose of determining and factors affecting their classification
Definition of cases of tuberculosis is necessary to:
• accurate recording of patients with the inclusion of data in the official
reporting;
• ensure priority treatment of patients with smear-positive cases,
the main source of infection;
• the appointment of appropriate standard treatment regimens;
• assessing the ratio of TB patients in accordance with the localization of disease,
bacteriological status and previous history of treatment;
• evaluating outcomes of treatment by group (cohort) analysis.
Factors affecting the classification of cases:
1. Localization of tuberculous process
2. Previously used approaches in the treatment of tuberculosis
3. The results of bacteriological examination
4. The severity of disease
2.2 The localization of tuberculosis are distinguished:
• pulmonary tuberculosis - a disease in which the pathological process
involved lung parenchyma. (Tuberculosis of intrathoracic lymph nodes
or tuberculous pleurisy without radiological signs of involvement
lung tissue in the pathological process belongs to the extrapulmonary
tuberculosis).
• extrapulmonary tuberculosis - tuberculosis of other organs and tissues
(Tuberculosis of the pleura, lymph nodes, abdomen, urogenital system,
skin, joints and bones, shells of the brain and / or spinal cord); diagnosis
should be on the basis of integrated clinical and radiological,
bacteriological, cytomorphologycal studies indicating
active extrapulmonary tuberculosis.
The combination of pulmonary and extrapulmonary localization refers to pulmonary
tuberculosis.
Miliary tuberculosis is a pulmonary, as accompanied by
pathological changes in the lungs.
Localization of TB is more relevant for the registration
reporting than for treatment regimens.
2.3 Information on previously used TB treatment are needed
for the appointment of an adequate treatment regimen for identifying patients with high
risk of developing drug resistance. Separation of patients on first
identified (new), and early treatment is essential in
epidemiological monitoring of tuberculosis in any given
Region (district, province) and in the country.
19
2.4 The results of microscopic examination are important to identify the most
infectious TB cases and their urgent treatment.
Pulmonary TB with positive smear
(Smear) is determined by the patient, who:
• If sputum smear microscopy prior to treatment revealed the ILO, even
under a single identification;
Pulmonary tuberculosis with negative smear
determined by the patient on the basis of criteria appropriate sanitary
epidemiological requirements and standards of clinical practice:
• not less than three-fold negative results in
Microscopic examination of sputum smears for the presence of AFB;
• radiologically determined changes corresponding to the active
pulmonary tuberculosis;
• No effect in therapy with antibacterial drugs
broad spectrum;
• doctor's decision (TSVKK), a full course of TB
chemotherapy.
Sputum Culture investigations are important for diagnosis of tuberculosis, but
produce an outcome requires a long time (from several weeks to months).
Therefore, a positive result in the planting negative results
smear microscopy is an indication of the presence of the patient's active
tuberculosis and confirms the diagnosis.
2.5 The severity of disease is determined massiveness of bacteria,
prevalence and localization process. Therefore, timely diagnosis
TB is very important in terms of prevention of its complications.
For the first time identified common clinical forms of tuberculosis (chronic
disseminated tuberculosis, tuberculous meningitis with a complicated course,
caseous pneumonia, fibrous-cavernous pulmonary tuberculosis, extrapulmonary tuberculosis
complications, destructive changes in lungs and mycobacterium in children)
considered advanced cases. Typically, the above forms develop
due to inadequate performance measures (diagnostic algorithm) to
timely detection of TB in the PHC network organizations and the PTO or late
treatment of patients. Need for mandatory clinical parsing such
cases with GSEN VET and primary health care with a protocol parsing and plan
activities.
2.6 Categories of cases for registration (types of patients)
The following types of tuberculosis:
1. a new case - the patient never previously did not take antidrugs or who took them less than one month
2. relapse - a patient who previously held a full course
TB treatment and outcome was "cured" or "treatment
completed, but which subsequently appeared mycobacterium
20
3. failure of treatment - the patient is assigned to a second course
antituberculosis therapy after failure of previous course
4. treatment after the break - a patient with a positive microscopy
smear, treatment resumes after a break lasting 2 and
more months
5. translated - the patient, who had arrived to continue treatment from another
medical institution, where he was registered as TB patients.
Upon completion of treatment, its outcome should be sent to the PTO primary
Registration
6. others - all TB patients who can not be attributed to
above definitions. This is a recurrence of lung
mycobacterium tuberculosis free and extrapulmonary tuberculosis. Such cases
must be isolated, and each situation requires pathomarphological
or bacteriological confirmation of diagnosis
7. Category IV - TB patients:
• a laboratory confirmed multidrug
resistant (multiresistance)
• With polyresistance with "treatment failures" in the modes I, II and III
categories
• with clinical resistance Office (extrapulmonary TB, TB in children and
adolescents)
Type IV category is selected in order to control all cases of tuberculosis
MDR. The decision to transfer the patient to
category IV, as well as the choice of treatment regimen adopted TSVKK.
Patients c polyresistance and clinical resistance, transferred to
Category IV and recorded in the journal TB 11 in connection with the inefficiency
chemotherapy first-line drugs in TB 01 and TB 03 should be the outcome
"Bad treatment".
Case management category IV is considered a special manual on MDR-TB.
2.7 Categories and medication regimes
Table 1 - Categories and medication regimes
Mode Categories
I New cases of pulmonary tuberculosis with bacterial and
extrapulmonary tuberculosis, as well as patients with pulmonary
Tuberculosis, having defeated more than 1 segment, with heavy
complicated and combined forms of pulmonary and extrapulmonary
TB without bacteria.
II patients with relapse of tuberculosis, treatment failure, treatment after
break, and others.
III patients with newly diagnosed limited
(Within one segment), uncomplicated pulmonary tuberculosis without
mycobacterium tuberculosis and extrapulmonary localization.
2.8 Results of the treatment (definitions for reporting)
21
Upon completion of treatment in each patient must be determined on the basis that
entered in the District Registry in accordance with one of the following categories
outcomes.
Table 2 - Definition of treatment outcomes
The result of treatment Definition
Cured smear results were negative in
end of treatment and in two previous studies
Treatment
completed
I'll take all the prescribed doses of antipreparations for the planned period of time, but does not
criteria "cured" or "bad treatment"
Failure treatment
The patient remains positive microscopy
sputum for the 5th month of treatment and later, or initially
negative microscopy, became positive
after the intensive phase
Violation
regime
The patient interrupted treatment for 2 months or more
Died patient died during treatment, regardless of the cause of death
Transferred
The patient dropped out from under the supervision of medical institution under the
observation of another and the result of his treatment is unknown
Note: treatment outcome should be communicated to the area
where the patient has arrived (where to begin treatment).
Transferred
Category IV
Patients with confirmed multidrug
resistance (at least to HR)
Notes:
- Combination of "treatment completed" and "cure" rate is
successful treatment
- The outcome of the "bad treatment" in patients with extrapulmonary tuberculosis, as well as
in
children with pulmonary tuberculosis without MBT can be determined
results of clinical and radiological investigations.
22
3. Laboratory services
Laboratory service is an integral part of national
TB program and plays a key role in the diagnosis and
monitoring the treatment of tuberculosis.
3.1 Organizational Structure
TB laboratory service corresponds to the three levels of the system
health service:
1. Peripheral laboratory (District)
2. Intermediate Laboratory (provincial, regional)
3. Central Laboratory (National laboratory)
3.1.1 Functions of the peripheral (district) level
Technical features:
• Preparation of smears and staining by Ziehl-Neelsen
• smear microscopy and incorporated
• Internal quality control
Organizational functions:
• Taking samples and issuing results
• Servicing
• Maintain laboratory journal (TB 04)
• Work with the reagents and consumables
3.1.2 Options for the intermediate (provincial, regional) level
All roles and responsibilities of the peripheral level, plus:
Technical features:
• Fluorescent microscopy (optional)
• Processing and decontamination of clinical specimens
• Allocation of cultures Office and their identification
• Determination of drug sensitivity
• Identification of other mycobacteria (not Office)
• Preparation of reagents and maintenance of peripheral laboratories
Organizational functions:
• Training of laboratory specialists, performing microscopy
• Assist staff in the performance of peripheral laboratories
microscopy and control of their work
• Improving the quality of studies and professional
Testing of microscopy for peripheral laboratories
3.1.3 Functions of the central (national) level
All the functions and duties of the intermediate (regional and regional) level
Plus:
Organizational functions:
• monitoring of the condition of laboratory equipment and ensuring its
repair
23
• Prepare and periodically update guidelines for
laboratory diagnosis of TB
Administrative functions:
• Training of laboratory specialists intermediate (regional and
regional) level
• Quality smear and culture in
intermediate-level laboratories.
• surveillance of the quality of DST, conducted in the laboratories of intermediate level
Research and surveillance:
• Organization of surveillance of primary and acquired drug
resistant Office
• Operational research on laboratory services
The quality of laboratory services depends on the amount of research and the number
personnel. To work effectively for the maximum number of microscopy
smears by TL at 1 laboratory should not exceed 20 strokes per day.
Professionalism in the reading of smears on the CI supports the viewing of at least
10 -15 strokes in a week, at least 2-3 a day. One laboratory, covering 100
Thousands of people, usually enough to achieve those goals - 2 - 20 strokes per day.
3.2 Organization of the microscopic and laboratory use
Equipment
When placing the equipment in the laboratory will cover three
separate sections:
1. well-lit section for the preparation and staining of smears
2. section for microscopy
3. section for the registration and storage of drugs
The laboratory should have:
- Desktops
- Sink for staining smears
- Screw the chair or stool
- Cabinet for reagents
3.2.1 The items required for preparation of smears:
1. Sputum containers
2. Bacteriological loop diameter of 3 mm
3. Slide (nonfat and no scratches)
4. Marking pencil
5. Tweezers
6. Bunsen gas burner or alcoholic
7. Metal Bank for burning the material used
8. Bottle of alcohol and sand
3.2.2 The items needed for staining smears:
1. Tripod for clean slides
2. Tweezers
3. Stand for drying stained smears
24
4. Carbolic fuchsin
5. 3% solution of hydrochloric acid or 25% sulfuric acid
6. Solution of methylene blue
7. Distilled water
8. Bunsen gas burner or alcoholic
9. Filter paper
10. Timer or hourglass
3.2.3 The items needed for the study under a microscope:
1. Binocular microscope
2. Immersion oil
3. Swabs for cleaning lenses
4. Box for smears
5. Toluene or xylene
6. Pens with blue and red ink
3.3 Preparation of smears:
Smears should be prepared simultaneously by multiple pieces (the maximum number of
one series - 12 strokes).
All manipulations for the preparation of smears should be standardized?
Instructions for preparation of smears (by Ziehl-Neelsen) in the Appendix.
3.4 Preparation of reagents for staining by Ziehl-Neelsen
3.4.1 Ziehl
Saturated alcoholic solution of fuchsin:
- Basic fuchsin - 3,0 g
- 96% ethyl alcohol - 100 ml
- Solution of basic fuchsin in alcohol (solution number 1)
Phenol solution:
- The crystals of phenol - 5,0 g
- Distilled water 100ml
- Dissolve phenol crystals in distilled water, may need
slight heating (solution number 2)
Working solutions
Mix 10 ml of solution number 1 and 90 ml of solution number 2, pour into a dark bottle.
Leave the label name of the solution, the date of preparation and storage life.
Crystalline phenol should be stored in tightly sealed container (vial) in
refrigerator.
3.4.2 Bleaching agent
25,0% sulfuric acid
Pour 300 ml of water in a liter bottle. Slowly add 100 ml of sulfuric acid,
pouring it on the bottle. Mix. Content heats. Never pour
water in sulfuric acid!
3,0% hydrochloric acid alcohol
Ethyl alcohol 96% - 97 ml
25
Hydrochloric acid - 3 ml (pour acid in alcohol).
3.4.3 Dokrashivayuschy solution
0,3% solution of methylene blue
- Methylene blue - 0,3 g;
- Distilled water -100 ml.
3.5 Investigation under the microscope
To study the stained smear is most suitable binocular microscope with
immersion lens (X 100) and the eyepiece (x 10).
3.5.1 Preparation of the microscope to the study:
1. Remove cover, inspect the microscope, verify the integrity of the optical system and
wipe with a dry cloth mechanical parts of the microscope
2. Turn power
3. Adjust the brightness until the desired intensity
4. Make sure that prepared for microscopy stained smears
well drained
5. With the rotation makrovinta omit the stage, the maximum
set him apart from the lens
6. Turn the revolving device to mount the lens with a small
magnification (10x or 20x) just above the condenser
7. Place on a glass table so that the swab was directly under the
lens, while necessarily ensure that the swab is at the top
plane of the slide
8. Lock the drug on the table with preparatoderzhateley
9. With the help of screws, moving the surface of the table with a bound on
its preparation, choose to view the smear plot
10. Adjust the interpupillary distance so that the right and
Left image is merged into one
11. Looking into the eyepiece, slowly rotating makrovint, raise the stage with
medication to the lens, ensuring a clear image of the object in the field of view
through the lens 10X or 20x
12. Turn revolver withdraw 10x or 20x lens from the ray path and move
lenses so that was free access to the drug
13. Drop the selected area smears a drop of immersion oil. Drop
should be free to fall on the glass
14. Turn the crown to establish a revolving device lens
increasing x 100 directly on smear
15. The lens must touch immersionnnogo oil and not to touch the object
glass to avoid damage to the lens or not to break the drug
16. Looking into the eyepiece with micrometer to tune the sharpness. In
execution time of the manipulation must be especially
careful and remove the screws on the small course, not allowing unchecked
full turn screws
17. In the event of a field of view of air bubbles in the operation settings
(Point of contact of the front lens with immersion)
be repeated
18. Explore the swab in accordance with the technique of reading the stroke (see below)
19. After the swab will be read, turn the gun so that
shift lens X 100, and remove swab from the table.
20. Wipe the lens with a piece of paper to clean the lens or
equivalent tissue.
21. Upon completion of the work to set the voltage regulator on
minimum and turn off the power.
22. Cover the microscope impermeable to dust cover
3.5.2 Technique reading smear
In microscopy should be viewed no less than 100 fields of view, to give
quantify the drug and to detect isolated mycobacteria. In
If the result of such studies is the negative, for
confirmation is recommended to view all 300 fields of view. At
considerable number of acid-fast bacilli is sufficient to investigate 20
- 50 fields of view in staining Ziehl - Neelsen.
Microscopic examination of the drug must be sure that no
one field of view of the drug is not visible again, so it is recommended
view the drug is always one and the same pattern: three parallel lines
the length of the drug.
View product starting from the top left selected in the smear of view,
gradually moving along the longitudinal axis of the drug until the end of the stroke, and then
again dropping down and moving in the opposite direction, and so on, passing all
visual field to the boundary of the stroke (Figure 1).
Figure 1. Lines of view smear size 1x2 cm
324 - number of log TB 04; 2 - number of servings Sputum
After microscopic examination, the slide should be released
from preparatoderzhatelya;
a) remove the slide from the microscope stage;
b) check the number on the glass and the direction of TB 05 and write the result of microscopy
log TB 04;
a) to remove the immersion oil deleted swab for a few seconds in
jar of xylene, or in the absence of xylene, wipe dry swab
cloth;
g) purified from the immersion oil swab placed in a box for
subsequent storage
TB bacteria - small red stick, slightly curved, more or
less granular, isolated, in pairs, groups, clearly visible on a blue background
smear. Count the number of acid-fast bacilli (AFB) and write
result.
Before the next stroke wipe immersion lens with a clean cloth.
3.5.3 Results
324-2
27
The number of detected bacteria determines the severity of the disease and the risk of the patient
to others. Consequently, the study should be not only qualitative,
but also quantitative. Registration results with the number of detected AFB
is as follows:
Table 3 - Registration of the results of microscopic examination
No AFB in 300 fields of view negative
1-9 AFB per 100 fields of view to indicate the exact number of
10-99 AFB per 100 fields of view +
1-10 AFB per 1 field of view + +
More than 10 AFB per 1 field of view + + +
Sending the results of research
The results of all medications must be recorded in the laboratory
Journal of TB-04. Then, based on the records in the TB-04 results are entered in the form of TB05, after which it is sent to a medical facility as quickly as possible.
3.5.4 Destruction of smears examined
Smear with found it KUB placed in a box and stored in
laboratory for subsequent quality control.
Following the quality control of smears with AFB (+) be removed to landfill
after preliminary disinfection (immersion in the disinfecting solution, boiling,
autoclaving).
Slides with negative smear result can be used
again after disinfection in the absence of mechanical damage (chips,
scratches, etc.).
3.6 Fluorescent Microscopy
Fluorescent microscopy using illumination from a quartz halogen
lamp, or from a mercury lamp of high pressure.
The advantage of fluorescence microscopy lies in the fact that the strokes
visible at lower magnifications, thus covered a large area
and as a result of time spent on the show is much smaller.
The disadvantage of fluorescence microscopy is likely to be accepted
artifacts of the acid-acid bacilli. Therefore recommended
check all found questionable coli under high magnification, and
smear-positive cases to confirm staining for Ziehl-Nielsen.
3.6.1 Preparation of reagents
Auramine About
- Auramine 0,1 g
- 95% ethyl alcohol 10 ml
- Dissolve the auramine in alcohol - solution № 1
Auramine is a carcinogen and therefore should avoid direct
contact with the powder or dye.
Phenol
- Crystals phenol 3 g
28
- Distilled water 87 ml
- Dissolve phenol crystals in water - a solution № 2
Mix solutions № 1 and № 2. The reagent is stored in tightly closed containers in dark
glass in the dark, away from heat sources. The solution is stored at room
temperature for 3 months. Reagent may be cloudy during storage, but it
not affect the quality of staining.
Bleaching solution:
- Concentrated hydrochloric acid 0.5 ml
- 70% ethyl alcohol (can be technical for potassium permanganate and
acridine orange) - 100 ml.
Carefully add concentrated hydrochloric acid to 70% ethyl alcohol.
Always add acid slowly to alcohol, not vice versa. The mixture may become hot.
The mixed reagent is stored in a bottle of dark glass. Solution can
stored at room temperature up to 3 months.
Hydrochloric acid alcohol 3,0%:
- Concentrated hydrochloric acid, 3 ml
- 95% ethyl alcohol (can be technical quality) 97 ml
Carefully add concentrated hydrochloric acid to 95% ethyl alcohol.
Always add acid slowly to alcohol, not vice versa. The mixture may become hot.
The mixed reagent is stored in a bottle of dark glass. Solution can
stored at room temperature up to 3 months.
Staining
As the dye is possible to use potassium permanganate, acridine
orange, 0.25% aqueous solution of methylene blue and acid fuchsin.
Potassium permanganate
- Potassium permanganate 0,5 g
- Distilled water 100 ml
Potassium permanganate in distilled water. The mixed reagent
stored in well-corked bottle of dark glass. The solution can be stored
at room temperature up to 3 months.
Acridine orange
- Anhydrous sodium phosphate disubstituted 0,01 g
- Distilled water 100 ml
- Acridine orange 0,01 g
- Dissolve the phosphate in distilled water, then add the acridine
orange and dissolve.
The mixed reagent is stored in a bottle of dark glass in the dark and away from
heat. The solution can be stored at room temperature up to 3 months.
Acid fuchsin
- Acid fuchsin 1gr
- Distilled water 300 ml
- Concentrated acetic acid 10ml
29
- Dissolve the acid fuchsin in distilled water, add acetic
acid. The solution can be stored at room temperature up to 3 months.
Methylene blue (0.25% aqueous solution)
- Methylene blue 0.25 g
- Distilled water 100 ml
- Dissolve the auramine in alcohol - solution № 1
Solution of methylene blue in distilled water. The solution can be stored at
room temperature up to 3 months.
All vials with reagents to write the name of the reagent, the date of preparation and time
storage.
3.6.2 Methods of staining
Place the numbered strokes to the bridge in the number of convenient and safe for
work (maximum 12). Make sure that the strokes do not come into contact with each other.
1. Pour all the slide auramine O solution and leave for 15 minutes
for staining. Make sure that the solution remained on the slides. Not
heat and do not use filter paper
2. Wash the smear with distilled water and remove the liquid
3. Fill-coloring solution or 3.0% hydrochloric acid alcohol for 3-5
minutes
4. Rinse with distilled water and remove remaining liquid
5. Pour strokes one prepared solutions: potassium permanganate,
acridine orange for 2 minutes, acid fuchsin and 0.25% aqueous
solution of methylene blue for 3-5 minutes and leave for staining
6. Wash the smear with distilled water
7. Leave the swabs to dry in the air, or in any case blot them
filter paper, etc.
8. Browse smears as soon as possible after cooking.
Precautions during staining:
1. Do not abbreviate the exposure time with a solution of hydrochloric acid or alcohol
sulfuric acid.
2. Avoid making too thick smears. This may
prevent the quality of contact with the de-coloring reagent, and
background dye can completely extinguish the presence of acidbacteria. Thick smears can flake off, leading to loss of material
and eventual transfer it to other strokes. Too intense background
staining may mask the presence of acid-fast bacilli
3. Smears stained with fluorescent reagents, should be viewed in
24 hours after cooking
4. With fluorescent microscopy mycobacteria appear as luminous
sticks. Background smear depends on the dye: a pale yellow background
determined by potassium permanganate, the orange background - acridine
orange, purple-red to black background - acid fuchsin, dark
background - methylene blue.
3.7 Quality control of smear Research
30
The quality control program is a microscopic lab
system designed to continuously improve efficiency, increase
reliability of the service, which would make microscopy tool
choice in the diagnosis and monitoring. The components of the program are:
- Internal quality control
- External quality control
- Improving the quality
3.7.1 Internal quality control of microscopic laboratory - a process
effective and systematic monitoring of routine work in the laboratory
regular basis. The functioning of this program ensures that information
obtained in the course of the research is accurate, reliable and reproducible. Internal
Quality control is the responsibility of all laboratory personnel.
Monitoring should be directed to the following:
- Placing laboratory
- Equipment
- Collection and delivery of material
- Material handling
- Methods
- Reagents
- Issuing results
Key aspects of a successful program of internal quality control
are:
- Adequately trained, motivated and cohesive staff,
- A reasonable choice of techniques,
- Willingness to recognize and correct errors
- Effective communication, the measures applicable to all TB laboratories in the tank.
3.7.1.1 The use of control (positive and negative) smears:
- Daily, along with ongoing smear should include monitoring
(Obviously positive and negative) smears
3.7.1.2 Quality control solutions and reagents:
- Daily quality control solutions and reagents: color, transparency and
crystallization;
- On all bottles of solutions and reagents should be marked with the date
preparation;
- Control the amount of reagents in stock (must be 6 month
reserve);
- To control the turnover of stocks at the stock (first use Those reagents and
dyes, the expiry date was coming to an end).
3.7.1.3 Quality control of the alignment of the light source of binocular
microscope.
Equipment should be tested regularly (every 6 months) monitored to ensure
accuracy and correctness of its range of specialist medical equipment.
31
3.7.2 External quality control
Spring quality assessment (BOK) on the WHO standard applies to the target
retrospective system, comparing results from different laboratories
through programs sponsored by external agencies, such as reference
laboratory. The main objective ROQ - to achieve comparability of results of different
laboratories, in accordance with the standards. Identified deficiencies will
direct efforts to remove them and improve quality.
There are three methods BOK, which are used to evaluate the performance of laboratories:
1. perekontrol smears of peripheral laboratories superior laboratory
2. Panel testing
3. monitoring visits
3.7.3 Improving the quality
The process by which the various aspects of laboratory work are
constant review to improve the reliability, efficiency and use
laboratory data. A key component of this process is data collection and
their analysis, as well as creative problem situations.
3.8 Neurotoxin methods for isolating Office
Questions of cultural studies described in the Methodological Recommendations NTSPT
Ministry of Health of the Republic of Kazakhstan "Neurotoxin methods to identify Mycobacterium
tuberculosis and determination
drug sensitivity to anti-TB drugs 1 st Line
2004.
Neurotoxin or bacteriological tests (seed) is used for
confirm the diagnosis of tuberculosis "in the case of a negative result
smear microscopy and extrapulmonary tuberculosis, as well as to determine
drug sensitivity of the Office.
The culture method for isolating the Office should be used:
- All newly diagnosed patients prior to treatment to control
Primary drug resistance to TB drugs
- In patients without conversion of a positive result microscopy at the end of
intensive phase (I and II category)
- Patients with unfavorable outcome who undergo treatment, and possibly
excreting resistant strains
- For the diagnosis of pulmonary tuberculosis with negative results
microscopy and differential diagnosis of complex cases
- For the diagnosis of extrapulmonary tuberculosis
32
Results of cultural studies
The intensity of growth indicate on a 4-point system:
Table 4 - Assessment of cultural studies
+ Unit, up to 20 colonies (scant MBT)
+ + From 20 to 100 colonies (moderate MBT)
+ + + More than 100 colonies (solid MBT)
+ + + + Confluent growth of colonies (solid MBT)
Currently, the international practice used methods of accelerated
diagnosis of tuberculosis - mycobacterium detection and determination of their sensitivity
to drugs using liquid media and fully
automated microbiological systems, such as the Bactec Midge-960.
Accelerated methods of diagnosis of tuberculosis have several advantages: short time
establishment and determination of bacterial sensitivity to drugs, the choice
adequate treatment in the light sensitivity to TAP the first row.
3.8.1 Definition of DST to the TAP
There are 2 methods to determine drug susceptibility testing (DST) to
TAP:
1. method of absolute concentration
2. method of proportions
3.8.1.1 The method of absolute concentration on solid media to determine
sensitivity to TAP the first row
In accordance with the criteria of stability in the experiments on its study recommended
use the following concentrations of tuberculostatic drugs:
Used concentrations of antibacterial drugs Line 1:
1) Isoniazid; 1 5 mg / ml
2) Rifampicin 40 mg / ml
3) Ethambutol 2, 5 mg / ml
4) Streptomycin 5, 10 ug / ml
Table 5 - Criteria of mycobacterium resistance to PTP
TAP 1ryada
Mycobacteria resistant during growth in
medium containing the drug in
concentration (in ug / ml)
1.Izoniazid
2.Rifampitsin
3.Etambutol
4.Streptomitsin
1
40
2
5
33
Table 6 - The activity of pure drug (mg active substance per mg
weight of the product)
Medicines micrograms active substance on
1 mg
Isoniazid 1.000 (100%)
Digidrostreptomitsin sulfate 750-850 (75-85%)
Ethambutol Hydrochloride 890 (89%)
Rifampicin 1.000 (100%)
The activity of drugs varies from one batch / series of drugs to another. These important
information is usually listed on labels of containers of drugs, packaging or
can be obtained from manufacturers.
3.8.1.2 The method of proportions on solid media to determine the sensitivity to
main TAP
The method of proportions is widely used in the world. To perform this method
used among the Lowenstein-Jensen (L-Q), and the stability of the tested strains
determined by the ratio of the number of colonies grown on medium with drugs to
number of colonies grown on medium without drugs.
This indicator allows to determine the presence of resistant mutants in general
viable population of colony-forming units. For
calculate the number of colonies grown on medium nth, we recommend seeding 2
dilutions. The advantage of this method is that the study used
standard inoculum and can count the number of colonies grown on the n-th.
Preparation of culture medium with drugs
Of great importance to obtain accurate results DST is
preparation of a medium containing drug. Below
critical concentration of drugs in the environment nth:
Isoniazid 0.2 mg / ml
Streptomycin 4 ug / ml
Rifampicin 40 mg / ml
Ethambutol 2 ug / ml
When cooking medium with drugs must take into account the activity of the drug,
which can vary from one batch / series of drugs to another and depending on
its manufacturer. This information is provided on the labels of containers, packages or
are provided by the manufacturer.
Isoniazid:
Active substance content of 1000 ug / ml
1) Preparation of solutions of drugs:
a) 20 mg isoniazid dissolved in 10 ml of distilled water - obtained
solution has a concentration of 2,000 ug / ml
In the future, from the working suspension prepared serial tenfold
Breeding: 10 - 1, 10-2, 10-3, and 10-4
(One for each suspension used the same 1ml graduated pipette).
Sowing bacterial suspension:
a) in 2 tubes with the medium nth without drugs (control tube) make planting
0.1 ml of the suspension diluted to 10-2, 10-4 and distribute over the entire surface
environment.
b) in 2 tubes with the medium nth containing each medicine makes seeding 0.1 ml
suspension diluted to 10-2 and distribute over the entire surface of the medium.
The tubes were kept in an incubator in an inclined position with loosely covered at
lids at a temperature of 370 C, until visible growth in medium without drugs,
then for 4-6 weeks with clogged traffic jams.
Interpreting results
The criterion of stability is 1% of the growth of bacterial populations for all these
drugs. After 4 weeks of incubation, growth on medium containing no drugs,
inoculated with a suspension of 10-4 compared with growth on the medium with the drug,
inoculated with a suspension of 10-2. If the number of colonies more on medium containing
drug testing strain is stable.
Since the ratio of 10-2 and 10-4 is as 1:100, the following formula can
used to calculate the% stability:
The number of colonies on medium with drugs in a dilution of 10-2 =% Stability
Number of colonies in medium without drugs in a dilution 10-4
If the growth of bacteria on a nutrient medium containing the drug, more than 1%,
strain is considered to be stable.
3.9 Quality control of bacteriological laboratories
3.9.1 Internal quality control of bacteriological laboratory is aimed at:
- Placing the laboratory and the organization of work;
- Laboratory equipment;
- The quality of the material;
- Processing of the material;
- Quality, availability and quantity of reagents;
- Methodology and procedure of sowing;
- Registration and issuance of test results.
Internal quality control - it is the responsibility of all personnel of the laboratory!
3.9.1.1 Placing the laboratory and organization of work:
- Ensure that the laboratory doors are always closed. Unauthorized persons should not be
be in the room laboratory. Office facilities, equipment and
Consumables are arranged to ensure effective and
safe operation
- Room cleaning is carried out in accordance with the approved schedule.
Work tops should be treated no less than 1 times per day
disinfectant solution
- Laboratories should use methods approved by the Ministry of Health of Kazakhstan
36
- A detailed description of each method used in the laboratory, should
stored in an accessible place
- All laboratory logs and files should be stored at least 5 years
3.9.1.2 Laboratory equipment:
- Equipment should be used in accordance with the requirements and
Manufacturer specifications
- Manual operation of the equipment should be kept in an accessible place
- The passport to the equipment regularly entered the date of service
- Equipment should be checked regularly by a specialist
3.9.1.2.1 Biological safety cabinet:
- The location BSHB should stay away from the entrance to the laboratory and
located in the side of the aisle (the movement of air from passing
people may violate the air curtain). This curtain is very fragile and
open windows or equipment that creates air movement (centrifuges) is
should be located near BSHB.
- Special attention should be paid to maintenance and timely replacement
filters.
- Jobs BSHB requires daily inspection of air velocity (22.86
m / s for BSHB class I and 22.86 - 30.48 m / s for BSHB class II) and indicators
gauge pressure of air entering the filter. In the case of the minimum
exceeding the marked level necessary to replace the filter.
3.9.1.2.2 Centrifuge
Every 6 months you should check brushes in electric motors.
3.9.1.2.3 Incubator
To register the temperature in the thermostat on a daily basis. Need to check the difference
temperature inside the thermostat at different levels.
3.9.1.2.4 Convolutors
Daily check the temperature. After each batch of media carefully handle
convolution.
3.9.1.2.5 Water Bath
Control the temperature before and during use. Each month
careful handling and cleaning.
3.9.1.2.6 refrigerator (2-8 º C):
Daily temperature control. Each month to process every 3
months to remove ice from the freezer.
3.9.1.2.7 Freezer
Daily check the temperature, cleaned every 6 months.
3.9.1.2.9 glassware
Do not use dull and cracked dishes. Sterile utensils store not
more than 3 weeks.
37
3.9.2 Diagnostic material and direction to the analysis:
- Analyses are performed only if the completed form to the direction
study. Do not allow the adoption of the material without appropriate
written instructions
- Directions must be delivered separately from the container with the material.
Areas of contaminated material must be subjected to
autoclave
- Do not accept referrals without any information on the containers. Not
to containers, which are impossible to read the inscription
- Leaking containers with the material immediately and autoclaved
send a request to re-analysis
- Assess the quality of the delivered material, and note if it is saliva
- When issuing the results in the direction you need to specify a red pen that
researched material - saliva (Do not rely on negative
result).
- Mark the date of receipt of the material in the laboratory, as well as any delay
when issuing the results, especially in the case of negative and crops with
Bark
3.9.3 Reagents and dyes
All the vial must bear the date of receipt and the date of
opening a new bottle. Any agent of unsatisfactory quality immediately
discarded and the list of available reagents is the corresponding record.
Need to control the turnover of stocks at the stock (the first to use the
reagents and dyes, the expiry date was coming to an end). Necessary
record the date when freshly prepared reagents and dyes
vials in the appropriate register.
3.9.4 Homogenization and decontamination:
- At the same time to handle a number of tests, which can be downloaded
centrifuge
- Monthly calculate the percentage sprout when sown clinical
material (an acceptable level of 2-3%). Less than 2% sprout says
excessively harsh treatment (much of the mycobacteria are killed). If
laboratory receives material delay, the percentage of sprout can be
more than 5%. In the case of a constant level of sprout above 3%, make sure that
decontamination procedure is adequate
- Monthly determine the percentage of patients examined with a view
diagnosis before treatment, in which microscopy gave positive
result, and sowing - is negative (the proportion of such cases should not exceed
3%)
3.9.4.1 Environment:
- Use fresh (not more than 7 days) eggs for cooking environment
Lowenstein-Jensen
- Monitor the temperature and clotting time environments. Remove the tubes, where
changed the color of the medium or formed bubbles
- Check all media for sterility by placing them in an incubator at 37 ° C for 24
hours
38
- Prepared medium stored in the refrigerator (no lighting) 4 weeks after
What untapped medium ejected
3.9.4.2 Test for verification of growth as media
Testing the growth characteristics of each party environment is carried out by
standard test strain, as the test strain using laboratory
(Museum) strain N37Rv or "wild" sensitive strain. Suspension Office
prepares standard Mc Farland-№ 1, then it is diluted to 10 - 6 and planted on 0.1 ml
on nutrient medium. If the nutrient medium on the rise 50-100 colonies environment quality is good.
3.9.4.3 Seeding
To avoid contamination of each analysis using a sterile pipette
and strictly follow the all the recommendations. If the same material (especially humidity) was
transported to the laboratory within a few days, the percentage of sprout is 5 - 10%.
39
4. Pulmonary tuberculosis
4.1 Methods of detection of tuberculosis
Cases of tuberculosis can be identified in two ways:
1. Passive detection
2. Active detection
The priority in TB control should be given to early detection and treatment
contagious disease.
Secondhand identify - identify the disease in persons seeking a medical
institution (clinic, hospital, diagnostic center, private clinics, etc.) with
complaining of cough. In this case, the most effective method of identifying
TB is sputum smear microscopy.
Smear microscopy in patients with prolonged cough (more than 2 weeks)
is the most important diagnostic tests to detect
the most dangerous forms of pulmonary tuberculosis.
In some patients, the presence of loss of body weight, fever, pain in the chest
cage, cough may be absent. But the doctor's responsibility is to suspect
TB in such patients and to conduct appropriate diagnostic
study.
Active detection - detection of the disease by prophylactic
flyuorogoraficheskih surveys. In Kazakhstan, this method is used for
Screening high risk groups. But remember that to diagnose TB
with confidence just by x-ray data rather
difficult. Fluorography and roentgenography can be subjective, and therefore
wrong, is not excluded and the factor of insufficient quality.
In any case, patients with radiological changes should be sent
to smear, before they are diagnosed.
Priority research in identifying TB should be
bacterioscopy smear. This method in the diagnosis of tuberculosis is responsible
modern requirements, conforming to the principles "evidence-based medicine".
4.2 Clinical signs
In tuberculosis of the lungs are no specific clinical symptoms. Therefore,
treatment the patient to health worker should be attentive to all
his complaints and state.
From the local features of pulmonary tuberculosis is the most frequent cough
sputum. But in most cases, the cough may be due to acute
respiratory diseases, chronic obstructive pulmonary disease, cancer
lung, bronchiectasis. Therefore, to ascertain the diagnosis,
needed sputum for MBT in all persons with long-term cough
(Over 2 weeks).
40
It is important to the strict observance of rules for collection of sputum for
objective result of microscopic examination.
Patients with suspected tuberculosis must pass three samples (samples) of sputum for
microscopic study on the ILO. And one of the samples should be
morning, and two samples must be collected under the supervision of a healthcare professional.
(Instructions for the implementation of sputum in the Appendix).
In tuberculosis possibly hemoptysis, the amount of blood can vary from
veins to massive bleeding. Therefore, detection of blood in the sputum
always have to explore it to the Office.
Pain in the chest, in principle, are not typical of pulmonary tuberculosis. But they can be
due to involvement in the process of the pleura. Shortness of breath can be caused by
pleural effusion.
Common symptoms such as weight loss, excessive sweating, fever,
Fatigue give reason to suspect tuberculosis, but can not confirm
diagnosis. In favor of tuberculosis shows a gradual increase in overall
symptoms for weeks and sometimes months.
At physical examination can sometimes detect local blunting
percussion sounds, limited wheezing may be present symptoms of pleurisy.
But often you can not find any pathology of the chest.
4.3 Diagnostics (diagnostic algorithm)
If you find the Office in the pathological material (sputum, pleural fluid,
cerebrospinal fluid, etc.), the patient should be sent to the PTO, where he
held clinical-radiological further examination for clinical staging
diagnosis.
In the absence of MBT patients with suspected tuberculosis and the presence
infiltrative (inflammatory) changes in the X - (fluorogram)
assigned a course of anti-inflammatory antibiotics wide range
steps to exclude non-specific pneumonia. In no case should
used drugs used to treat tuberculosis? If at
X-ray (fluorogram) Other changes (rounded shadows, cavities, an increase
intrathoracic lymph nodes, etc.) the patient should be directed to
consult a TB specialist to decide on further tactics
(Additional studies such as bronchoscopy, CT, YAMRT etc.).
4.4 Clinical classification of tuberculosis.
The classification of tuberculosis based on the ICD revision X and consists of four
main sections: clinical forms of tuberculosis, characteristic of tuberculous
process, complications of tuberculosis, the residual changes after the treatment
tuberculosis.
41
4.4.1 Clinical forms of tuberculosis differ in localization and clinical
radiological signs of taking into account the pathogenetic and pathologic
Characteristics of tuberculosis process. Main clinical forms
TB are:
Tuberculosis of respiratory organs:
Primary tuberculosis complex
Tuberculosis of intrathoracic lymph nodes
Disseminated tuberculosis
Miliary tuberculosis
Focal pulmonary tuberculosis
Infiltrative pulmonary tuberculosis
Cheesy pneumonia
Pulmonary tuberculoma
Cavitary disease
Fibrous-cavernous pulmonary tuberculosis
Cirrhotic tuberculosis
Tuberculous pleurisy (including empyema)
Tuberculosis of the bronchi, trachea, upper respiratory tract
Tuberculosis of the respiratory system, combined with professional dust
Lung Disease (koniotuberkulez.
Tuberculosis of other organs and systems:
Tuberculosis of meninges and central nervous system
Tuberculosis of intestines, peritoneum and mesenteric lymph nodes
Tuberculosis of bones and joints
Tuberculosis of the urinary and genital
Tuberculosis of skin and subcutaneous tissue
Tuberculosis peripheral lymph
Tuberculosis eye
Tuberculosis of other organs
4.4.2 Characteristics of tuberculosis process is given by the localization process, by
clinical and radiological signs and the presence or absence of
diagnostic materials sick of Mycobacterium tuberculosis (MBT).
• Location and distribution: a lung lobes, segments, and in other
bodies lesions
• Phase:
a) infiltration, decay, contamination
b) dissipation, sealing, scarring, calcification
• MBT:
a) the allocation of Mycobacterium tuberculosis (MBT +)
b) without isolation of Mycobacterium tuberculosis (MBT-)
4.4.3 Complications of tuberculosis:
Haemoptysis and pulmonary hemorrhage, spontaneous pneumothorax, pulmonary heart
failure, atelectasis, amyloidosis, fistulas, etc.
4.4.4 Residual changes after the treatment of tuberculosis:
a) Respiratory:
fibrous, fibro-foci, bullosa dystrophic, calcinates in the lungs and
lymph nodes, plevropnevmoskleroz, cirrhosis;
b) other bodies:
cicatricial changes in various organs and their consequences, calcification, etc.
Wording of the diagnosis in TB patients is recommended in the next
sequence: the clinical form, location, phase of the process
MBT (MBT + or MBT-), complications, concomitant diseases.
Examples of wording of the diagnosis:
1. Infiltrative tuberculosis of the upper lobe of right lung, the phase of disintegration and
contamination, the Office +. Pulmonary heart I degree. 2 diabetes
Art.
Revision in the diagnosis of clinical forms of tuberculosis are encouraged to
when re (failure of treatment, treatment after the break) or at the end of treatment
(Cured, treatment completed).
Patients with inactive change after full treatment course successfully put
diagnosis of residual changes after (specify clinical form of tuberculosis) "
Revision of the phase of the process when making a diagnosis can be carried on any
stage monitor patients.
For patients who have been made kollapsohirurgicheskie or other
interventions for tuberculosis, it is recommended:
a) persons who have been following the operations in the lungs remained unchanged
tuberculous nature, should be diagnosed condition after operation
intervention (specify the nature and date of intervention) about one or another form
TB
b) if the remainder (kollabirovannoy) lung tissue, or other body
preserved or that the TB change is taken into account, this form
tuberculosis.
The diagnosis, moreover, reflects the nature of surgical intervention on the
tuberculosis.
43
5. Extrapulmonary tuberculosis
The purpose of the section - to present the principles of detection, diagnosis and treatment of
extrapulmonary
tuberculosis.
5.1 Identification and diagnosis of extrapulmonary tuberculosis
Extrapulmonary tuberculosis (VLT), usually detected in later stages that
explained on the one hand the objective difficulties of diagnosis, but on the other lack of awareness of physicians infrared detection of the disease. Most patients
VLT primarily appeals to specialists OLS, so they should
as soon as possible to suspect TB and send the patient to a specialist.
An algorithm for detecting and diagnosing extrapulmonary tuberculosis is carried out on
three levels:
1. The first level - hospitals OLS, which held the primary
identification of persons with suspected VLT among patients of all ages
Based on the clinical (complaints, medical history, examination), laboratory (blood,
urine), radiological examination of the chest and
special methods depending on the localization process. If
available biological material must be 3-fold in the study
Office by microscopy. Detection of AFB at least once or
availability of clinical and radiological signs of suspected TB
is an indication for referral of TB
dispensary.
2. The second level - TB dispensary, where being
additional examination for histological, cytological and
Microbiological verification of the diagnosis. If the full range of available
research methods are not allowed to justify the diagnosis, you can assign
non-specific drugs for 2 weeks. This estimate is not final
result, but the dynamics of the process.
3. The third level - NTSPT RK, which send patients
unidentified reliably diagnosed in-depth survey and
and patients with indications for surgical treatment.
Chemotherapy for all patients with extrapulmonary tuberculosis is on
standard schemes. Surgical treatment is carried out to address TSVKK.
5.2 The main clinical forms of extrapulmonary TB
The section presents the main localization VLT, the principles of diagnosis and
treatment.
5.2.1 Tuberculous meningitis
It is one of the main causes of death in tuberculosis. Distribution Office in
meningeal membranes and the brain occurs in the process of hematogenous dissemination
infection from the primary tumor or miliary TB. The disease develops
gradually, marked malaise, irritability, Low-grade fever
etc., are characterized by inconsistency general state of gravity. By 2 days ago
44
symptoms of the disease are increasing: the headache progresses, there is stiff
neck. Subscribes basal neurological symptoms
(Lesion of cranial nerves, usually III, VI, VII, IX, XII pairs). 3 weeks may
appear paralysis of the limbs, stupor, stopper, coma. Often there
hydrocephalus, which is one of the reasons for the decrease of consciousness. By week 4 may
died. It is possible and "atypical" acute onset of high
fever and meningeal symptoms, especially in young children.
Decisive in the diagnosis of a study of cerebrospinal fluid. For
Tuberculosis is characterized by increasing pressure to 300-400 mm water column, cells
usually up to 500 per mm3 with the prevailing polymorph early in the disease, later predominance of lymphocytes. Protein level increased up to 3,3 g / l, glucose reduced. Positive reaction sedimentary nowadays-Appelt and Pandi. At
standing through the night falls delicate film of fibrin in a grid.
Office in the cerebrospinal fluid is rarely found (10-20%). Recommended
method for rapid planting sensitive culture. In normal spinal
fluid does not exclude TB, particularly in HIV-positive patients.
The range of mandatory surveys include a study fundus,
X-ray of the chest, a skull in two projections. Informative CT, while
spinal form of magnetic resonance imaging. Possible individual or
multiple intracranial tuberculoma.
Differential diagnosis often done with serous meningitis
viral etiology, purulent meningitis, a brain tumor.
Treatment should begin as soon as possible, without waiting for the results
microbiological surveys. Preference is given to the intensive phase
streptomycin, as the concentration of ethambutol in the cerebrospinal fluid is low.
Showing the use of systemic corticosteroids, especially in the presence of focal
neurological changes, high pressure, cerebral edema and hydrocephalus.
5.2.2 Tuberculous pleurisy
Most often occurs as a complication of tuberculosis of any localization, but may
run as an independent clinical form and be the first clinical
manifestation of tuberculosis in the body. According to the clinical forms are distinguished fibrinous
(Dry), pleural effusion and tuberculous empiemu. In connection with this clinic
tuberculous pleurisy diverse.
Fibrinous pleuritis begins gradually with the appearance of chest pain. Patients often
indicate hypothermia, SARS. Pain may radiate to the shoulder girdle
abdominal cavity. A characteristic diagnostic feature is the noise of friction
pleura. Dry pleurisy is often recurs, which is characteristic of tuberculosis.
Pleural effusion accompanied by a sharp rise in temperature, gradually
increasing shortness of breath, constant oppressive pain in his side. In this case,
Patients are usually treated themselves to a doctor. It is significant shortening
percussion sounds, which depends on the size of exudate.
45
Festering pleural effusion (empyema) is accompanied by severe clinical
pattern - high fever, shortness of breath, night sweats, weight loss.
Radiological examination is characterized by fibrinous pleuritis
decreasing the transparency of the lung field. Informative is
computer diagnostics, which allows the seal pleural
sheets and their deformation.
In the presence of free exudate on the plain film is determined by the typical
painting shading the lower parts of the lung field with an oblique upper limit, the displacement
mediastinal organs in the opposite direction. Shadow of intense and homogeneous.
One is the chest x-ray, during which you can
see a change in the level of free exudate during respiration and movement
of the patient's body.
To detect changes in the lungs, it is necessary to make radiographs after
fluid removal. To audit the lungs and mediastinal organs shows a computer
tomography.
In the case of penetration of air in the pleural cavity of the upper limit of effusion
takes a horizontal position.
Partial adhesion of pleura exudate may osumkovyvatsya and
radiologically defined shadow in the form of a convex lens, a triangle or strip.
Detection of effusion in the pleural cavity causes no special difficulties, much
harder to prove its nature. Besides tuberculosis, pleurisy can be associated with
pneumonia, lung cancer or mesothelioma of the pleura, pulmonary infarction, collagen
diseases.
For detection of pleural effusion is necessary to conduct diagnostic
pleural puncture. Observation tactics without pleural puncture justified
only at diagnosis, the presence of a small amount of effusion or
when the effusion is caused by congestive heart failure. However, since
pleural puncture is a relatively simple procedure, it should perform
without hesitation when indicated. In patients with massive pleural effusion,
accompanied by shortness of breath, pleural puncture is performed in therapeutic
purposes. With a single puncture should not delete more than 1000 ml of fluid
Investigation of pleural fluid is conducted in the following areas:
appearance, cellular composition, biochemical and bacteriological study. For
tuberculous pleurisy is characterized by a serous exudate with a predominance of
cellular composition of lymphocytes. The Office can be found in 5-15% of cases.
Undoubtedly, the discovery of the Office the most convincing evidence TB
the etiology of pleurisy, but their absence does not deny tuberculosis.
Of great importance in the diagnosis of tuberculous pleurisy, especially in children, have
tuberculin tests. As a rule, pleurisy of tubercular etiology, response
to tuberculin were hyperergic character. But in patients with purulent pleurisy they
are weakly positive or even negative.
Tuberculous pleuritis may be associated with specific inflammation of the bronchi,
especially in primary tuberculosis, which can be found at bronchoscopy
study.
46
Scoring method for diagnosis of tuberculous pleurisy is thoracoscopy with
follow-up biopsy of the pleura. On examination of the pleura can detect the characteristic
for tuberculosis papulose rash. In the biopsy finding of elements of tuberculosis
granulomas confirms the etiology of tuberculosis pleurisy. Tissue samples were subject
mandatory bacteriological research.
The outcome of exudative pleurisy is usually the resorption of exudate without
visible permanent change. A long course on the pleura may be
pleural layers. In patients with purulent pleurisy disease can take
chronic course with the formation of chronic empyema, which requires surgical
treatment. If such is contraindicated, then the prognosis is extremely unfavorable.
5.2.3 Tuberculosis of bones and joints
The section presents the principles of timely detection and diagnosis of osteoarticular tuberculosis.
Patients with osteo-articular tuberculosis is 3-5% of all patients
tuberculosis. Well, they get them at any age. In children and adolescents disease
distinguished by a higher incidence and significant disabilities
affected part of the skeleton. Approximately half the cases, tuberculous process
localized in the spine, less frequently in the hip and knee joints, and rarely in the
elbow, shoulder joints, bones, feet, hands and elsewhere.
The clinical symptoms of osteo-articular tuberculosis are divided into general and
local. Among the general expressions which give reason to suspect
TB - symptoms of intoxication: malaise, decrease
efficiency, Low-grade fever, sweating, etc.
Local symptoms depend on its localization and developmental stages
tuberculous inflammation and described in detail in the learning and teaching
materials.
The basis of diagnosis of osteoarticular tuberculosis is a carefully assembled
history of the disease, the elucidation of information about contact with patients with tuberculosis.
To refine the diagnosis of osteoarticular tuberculosis needed
microscopic and bacteriological study of pathological material
MBT obtained during biopsy, surgery or a puncture, as well
histological examination of postoperative material.
Upon receipt of the growth of bacteria colonies of acid is mandatory
the test for drug sensitivity to first-and secondseries.
Currently, the use of modern radiological diagnostic methods,
such as CT and MRI, allows rapid identification of tuberculosis of the spine and
joints at the initial stage of the disease, to identify small isolated pockets
degradation, which, when hard X-ray determined.
In the presence of functioning fistula appointed fistulography for
determine the nature of the fistula.
47
5.2.3.1 Tuberculosis of the spine (tuberculous spondylitis)
Initial (prespondiliticheskaya) phase of the disease usually does not
characteristic symptoms of the disease. The clinic can be manifested in the form
transient local pain after normal daily loads.
Survey radiograph of the spine at this stage does not diagnostic
values. However, CT and MPT make it possible to detect the primary inflammatory
destructive foci in vertebral bodies.
Spondiliticheskaya phase, is characterized by general (malaise,
weakness, Low-grade fever) and local symptoms (skirted
pain, restriction of movement and pain in the spine, stiffness in the muscles
back). Then join neurological disorders, which have pronounced
HYDRATED segmental nature of the radiating pain in the extremities, pelvis, abdomen, chest
cell. In engaging in the tubercular process end plates
spine and break the pathological elements in juxtaspinal soft
tissue formed paravertebral abscess. In lesions of the posterior
reflex-plate spine has a risk of failure of tuberculous
focus in the spinal canal, which leads to serious neurological
violations, up to paraplegia with limb dysfunction of pelvic
bodies and trophic disorders of soft tissues.
Early radiological signs are narrowing of the intervertebral
slot, contact destruction of affected vertebrae, education
paravertebral, sometimes epidural abscesses. With progression
process between the vertebral bodies formed destructive cavity, often with
inclusion of seizures. In the contact degradation involved 2-3 vertebrae, but
sometimes there are 2 and 3 separate localization process in the spine.
In the presence of abnormalities in the spinal cord for diagnostic purposes
performed contrast myelography, which allows the violation
patency of the anterior subarachnoid space. Full suspension
contrast agent for treatment of tuberculous spondylitis occurs in late
identification of the disease with the presence of symptoms of functional disorders of the spinal cord.
Differential diagnosis is carried out mainly with haematogenous
vertebral osteomyelitis, ankylosing spondylarthrosis (disease
Spondylitis), hemangiomas and metastases.
5.2.3.2 Tuberculosis of the hip joint (hip joint disease)
In the initial (preartriticheskoy) phase of the disease goes unnoticed, there may
discomfort in the joint, recurrent lameness associated with pain,
fatigue patient limb by the end of the day, there may be change in gait.
Characteristically increase pain, which often extends to
region of the hip and knee, a gradual decrease in movements
the affected joint may develop soft tissue infiltration. Despite
the presence of complex or more above the local symptoms, the total
the patient's condition at this stage of the disease is usually satisfactory,
no symptoms of intoxication.
At arthrogram usually epimetaphysis femur or near
the roof of the acetabulum are defined foci of local osteoporosis
indistinct contours. Sometimes it can be traced to the cavity sclerosed
edged, sometimes containing bone sequesters, or other soft tissue
pathological elements.
48
At the height of the disease (arthritic phase) along with general symptoms rapidly
pronounced local symptoms: pain, exacerbated with movements; flexion
and adduction contracture, violation oporosposobnosti. Characterized by increasing
local temperature, a symptom of Alexandrov, infiltration periarthric
soft tissue, abscess in the distribution of periarticular soft tissue,
intermuscular space, sometimes in intrabasin space. If
break through the skin formed an abscess fistula.
Tuberculosis of peripheral lymph nodes (TPLU) in Kazakhstan is
one of the most common forms of VLT.
Most often affects the cervical lymph nodes, sometimes on both sides,
much less axillary and inguinal lymph nodes. In the beginning
disease defined by the mobile, painless lymph chain
nodes almost compact consistency. In the cervical area of the inflamed lymph nodes
usually located on the leading edge along m. sternocleidemostoideus, in
submandibular and supraclavicular areas. In a subsequent lymph nodes lose their
mobility through the development of adhesions between the nodes and surrounding tissues. Coming
Depending on the degree of perifocal inflammation, they form packs
swollen lymph nodes, skin over a conglomerate of lymph nodes blushes
determined by the fluctuations and is rankling inflamed lymph nodes. Sometimes
ulcers, and open the form fistulas. Against the background of functioning fistula can
others appear swollen lymph nodes at various stages
development. The clinical course of disease - usually a chronic, it is small
impact on the overall condition of the patient. May be: Low-grade fever,
fatigue, sweating, decreased appetite.
Diagnosis TPLU
Diagnosis of tuberculosis of peripheral lymph nodes is set to
Based on anamnesis, clinical examination, X-ray
studies of the chest, tuberculosis microscopy, bacteriological
Research and puncture biopsionnogo material on Mycobacterium tuberculosis
and the result of histological examination of postoperative material
tuberculosis. If possible, use additional methods of investigation,
such as ultrasound, computed tomography (CT), nuclear magnetic
resonance (NMR). Application of these methods allows
differentiate the pathology of the lymphatic system in the most difficult
clinical cases.
Informative and valuable methods for diagnosis TPLU are methods
tuberculosis microscopy, bacteriological examination puncture,
biopsionnogo material on Mycobacterium tuberculosis and histological
postoperative study material for tuberculosis. However, studies
puncture and biopsionnogo material obtained from lymph node
smear and bacteriological method does not always give
positive results, as the material under study often does not
Mycobacterium tuberculosis. Verification of diagnosis TPLU is based on
histological examination of postoperative material.
In the complex treatment TPLU generally used conservative
Surgical treatment and pathogenesis. Patients with increased
peripheral lymph nodes prior to the appointment of TB
treatment to exclude a nonspecific inflammation of lymph nodes should
a course of antibiotics of broad-spectrum.
Once the diagnosis has newly diagnosed patients assigned to treatment
Category I, patients with recurrent process, treatment failure after intensive
phase and the treatment interruption for more than 2 months of treatment assigned to category II.
Surgical treatment is indicated in cases of ineffective conservative
treatment in the presence of functioning fistulas, etc. Along with this, in the complex
52
treatment TPLU used pathogenetic treatment: detoxication therapy,
vitamin therapy and local application of physical therapy: ultrasound therapy,
medicinal electrophoresis, low-energy laser therapy.
5.2.5 Abdominal tuberculosis (mesenteric lymph nodes, tuberculosis
intestines, peritoneum)
The main form of abdominal tuberculosis is tuberculosis mesenteric
lymph nodes (mesenteric adenitis). The disease is often not limited
lesion of the mesenteric lymph nodes and spreads to the serous membrane
intestines, pelvic organs.
Tuberculosis of the intestine occurs with the progression of pulmonary tuberculosis,
mesenteric lymph nodes, but sometimes found as
independent disease.
Tuberculous peritonitis (inflammation of the peritoneum TB) - rare
localization of tuberculosis, occurring mostly in young adults.
The clinical picture of abdominal tuberculosis is characterized by large
polymorphism. Constant symptoms are abdominal pain, often
localized in the umbilical region. Patients complain of reduction
appetite, periodic nausea, vomiting, violation of his chair. Typically, they
detect gastritis, abnormal liver function. On examination can reveal
bloating, pain and tension of the abdominal wall, can sometimes
palpate conglomerates cemented mesenteric lymph nodes. At
tuberculous peritonitis may be keen for signs of marked
intoxication. With the accumulation of exudate in the abdominal cavity can be
enlargement of the abdomen.
Radiological examination indicated enlargement and stricture
loops of small intestine, dysmotility of the stomach and intestines. Increased
lymph nodes can be detected by ultrasound and
CT. Availability Calcinates shows
tuberculous lesions.
Diagnostic significance of expression (hyperergic) reaction
tuberculin in the tuberculous etiology of peritonitis and mezadenita.
In difficult diagnostic cases shown laparoscopy with biopsy and
fence exudate for histological and bacteriological study.
At laparoscopy can detect rashes tubercles,
adhesions, and in biopsy lymph node and peritoneum - kazeoz. Exudate from
abdominal cavity is exposed cytological and microbiological
investigation.
Acute abdominal tuberculosis require differential
diagnosis of acute appendicitis, acute cholecystitis, acute
pancreatitis, acute adnexitises, acute intestinal obstruction, disease
Crohn. Chronic forms must be differentiated from peptic ulcer disease
cholecystitis, malignant tumors, chronic gynecological
diseases, etc.
5.2.6 Tuberculosis of the urinary system
53
The disease is caused by hematogenous spread of infection from the primary
hearth. As a rule, is a late manifestation of infection and mainly affects
patients older than 50 years. Lesions first appear in the cortical layer
kidneys, then spread and destroy the kidney tissue with the formation of cavities.
The infection can spread to the urethra, which can obturirovatsya; on
bladder, and then on the prostate, seminal vesicles and epididymis.
5.2.6.1 Clinical manifestations of tuberculosis of the urinary system are diverse and
have pathognomonic signs. In many patients the disease for a long time
proceeds under the guise of chronic pyelonephritis, urolithiasis,
polycystic tumors, cystitis and other diseases, some patients subjective
Symptoms of TB of the urinary system for a long time non-existent. Common
condition of most patients remains satisfactory even
polikavernoznom tuberculosis of the kidneys. Tuberculous intoxication is poorly expressed. Not
there is a parallelism between the degree of destruction of the kidneys and the general condition
patients.
The most frequent manifestations of the disease are:
� frequent urination
� pain when urinating
� pain in the lumbar region (blunt or sharp)
� blood in the urine (sometimes this may be the only symptom). Remember that
hematuria may be caused by kidney tumor.
� pus in the urine (the result of research on secondary flora may be
negative)
� an abscess in the lumbar region (in advanced cases)
With a combination of frequent, painless urination with negative
the result of urine culture in the secondary flora in the presence of pus in her best
probable tuberculosis.
5.2.6.2 Diagnostics
� urine registers the presence of erythrocytes and leukocytes, is characterized
decrease in pH and increase in the proportion. To identify the source of
erythrocytes and leukocytes is necessary to use two-glass test. First
portion of urine (5-10 ml) collected in the first glass and is almost flush
with the urethra. The rest of the urine collected in the second glass. If the above Pyuria
in the first glass, it indicates inflammation in the urethra or
bodies, in her opening, that is, in the prostate gland or seminiferous
ways.
Hematuria (red blood cell) may be one of the early symptoms of TB
kidney.
Pyuria is usually determined in all patients with tuberculosis, urinary
system.
Proteinuria is a non-permanent sign, in the early stages of the disease protein
may not be.
Investigation of urine on the Office. Should be collected at least three samples
morning urine on different days and immediately sent to the laboratory in order to avoid
development of an alkaline reaction. Microscopy of urine sediment is mandatory
for all patients with suspected tuberculosis of the urinary system. Most
54
reliable method for diagnosis of tuberculosis is sown in the Office, although this
method requires time-consuming.
� X-ray examination. The best method in the study of pathology
kidney and urinary tract is the excretory (intravenous) urography.
� Clinical examination of the testicles and their appendages can clarify the picture (cm
Tuberculosis section of genital tract).
� radiograph of the chest (usually without pathology)
� Tuberculin test (little informative)
In case of doubt in the diagnosis, you must first be the standard treatment
nonspecific inflammation.
5.2.6.3 Treatment
A standard course of chemotherapy according to the category of treatment under
direct supervision of a healthcare professional. To reveal the reaction
treatment is recommended sowing culture of urine once a month.
Possibility of surgical treatment in case of indications for removal of the damaged kidney
or a large renal abscess, stricture (obstruction), urinary tract.
5.2.7 Tuberculosis of the genital tract in men
The men most often strikes the region - the epididymis, prostate and seminal
bubbles. These bodies may be involved in the pathological process separately or
together. The infection enters through hematogenous or from the kidneys through
urinary system.
Clinical symptoms - frequent complaints of discomfort of one of the testes. But more
is affected appendage, while it increases, it becomes thick and bumpy.
The process can be transformed into an abscess and fistula formation conclude.
Need to investigate the prostate and seminal vesicles through the rectum. Prostate
becomes uneven, and through it you can palpate the seminal vesicles.
Diagnosis includes a mandatory urine for MBT, X-ray
study of the kidneys. Required differential diagnosis of acute epididymitis and
tumor. You should know that nodular formation of more typical of tuberculosis.
A full course of standard chemotherapy usually gives good therapeutic
effect. Surgical treatment is indicated in complicated course (abscesses, fistulas),
as well as in suspected tumor.
5.2.8 Tuberculosis of the genital tract in women
In women, tuberculosis usually affects the fallopian tubes, mucous
uterus, ovaries and cervix. Vagina and external genitalia are affected
rare.
Clinical manifestations
� Infertility is the most frequent reason for seeking medical
help. Routine screening for infertility should always include the search
signs of tuberculosis.
� abdominal pain, menstrual disorders
55
� The formation of an abscess in the fallopian tubes.
� Ectopic pregnancy
Palpation of the pelvic organs may be detected in the seal
fallopian tubes. Diagnosis can be confirmed by bacteriological and / or
histological examination of biopsy intrauterine, vaginal discharge
or menstrual blood. If possible, a radiological
examination with contrast.
A standard treatment for tuberculosis in accordance with the category.
Surgical treatment is indicated, if necessary, restore
fallopian tubes and the ability to conceive.
5.2.9 Tuberculosis of eye
Proportion of tuberculosis eyes in Kazakhstan among extrapulmonary forms for the past 5
years has decreased from 1,8% to 0,8%.
Nevertheless, tuberculosis eye is one of the main causes of blindness and
low vision, leading to disability.
The specific eye disease develops as a result of hematogenous
dissemination of the ILO and therefore is often a complication of primary
tuberculous process. Identification of patients with suspected tuberculosis
damage done by ophthalmologists general medical network in the absence of effect
carried out by non-specific therapy. Diagnosis and treatment of specific
should be implemented in TB institutions. Most
informative diagnostic methods are tuberculin (reaction
Mantle) and the data eye tests (ophthalmoscopy,
biomicroscopy, peri-campimetry).
Among the local symptoms are most informative and large sebaceous precipitates and
stromal rear synechia in the presence of opalescence chamber moisture and maintaining
sensitivity of the cornea, as well as chorioretinal foci of rounded, not
confluent nature, with predominant localization in the choroid, and in half
cases in the central zone of the ocular fundus.
The diagnosis of tuberculosis can be confirmed by eye in the presence of 2-3 major
criteria: typical eye pattern, focal tuberculin
reaction-type acute inflammatory process and vneglaznoy localization
tuberculosis.
Treatment is carried out in accordance with the principles of standard chemotherapy
tuberculosis. Recommended subkonyunktivalnye, parabulbarnye injections and
instillation of anti-TB drugs. For pathogenetic therapy
used anti-inflammatory; antisensitizer; funds
normalizes metabolism, stimulating resorption and repair.
5.2.10 Tuberculous pericarditis
There is a second chamber in the presence of tuberculosis in any organ, although it may be
the only visible sign of tuberculosis. The disease begins with education
fibrinous exudates in the pericardial cavity.
56
The clinical picture of tuberculous pericarditis polymorphous, the beginning is
gradual, often the disease is recognized too late. Diagnosis often
hampered by the lack of severity of symptoms in early disease. Since
in the pericardium own pain receptors or non-existent, or are in
small numbers, the pain of pericarditis due to a greater extent
inflammation of the adjacent parietal pleura. Therefore, the pain associated with breathing
movements, especially during deep breathing or coughing, recalling the pain of illness
lungs.
With the accumulation of serous effusion appear signs of circulation tachycardia, low blood pressure, signs of right heart
insufficiency, edema in the legs, hepatomegaly, ascites.
Changes in the electrocardiogram does not depend on the etiology of pericarditis and
characterized by a low voltage of the waves in all standard leads. After
drainage effusion voltage spikes recovered. Characteristic change in the wave ST and T.
Echocardiography can detect changes in the fibrous pericardium, sediment
fibrin, calcium or fluid in the pericardial space.
Diagnostic value represents pericardiocentesis for liquid and
subsequent research on the Office. Is desirable biopsy of the pericardium and
histological examination of biopsy. With the development of cardiac tamponade is shown
aspiration pericardiocentesis, removing 200-300 ml fluid rapidly improves
circulation.
In the treatment of exudative pericarditis in the beginning of the disease effectively appointment
glucocorticoid drugs. Surgical treatment is carried out to address TSVKK.
5.2.11 Tuberculosis skin
A rare form of tuberculosis. Tuberculous lesions of the skin is one of the manifestations
tuberculous infection and often accompanied by pulmonary tuberculosis, lymph nodes
and other organs. Among tuberculous lesions distinguish focal forms
(Mild lupus, and ulcerative skrofuloderma TB) and disseminated
form.
Diagnosis of tuberculosis confirmed by histological and bacteriological
study of biopsy from the affected area of skin.
The differential diagnosis should be made with syphilitic tubercles,
chronic discoid lupus erythematosus, nodular erythema, leishmaniasis, etc.
57
6. TUBERCULOSIS CHILDREN
There are approximately 1.3 million new TB cases and nearly 450 000
deaths from tuberculosis among children under 15 years. In most cases, children
infected by adult patients with tuberculosis.
Indicators of tuberculosis among children reflect the situation of TB control
adults.
6.1 Risk factors for tuberculosis in children
The risk of TB in children depends on the nature of TB contact
(Number of infectious patients, the duration of contact) and the susceptibility of children.
The key risk factors for tuberculosis in children are:
• household contact with sputum
• age less than 5 years
• Malnutrition
• HIV - infection
Additional risk factors are:
6.2 Clinical signs of TB in children
Clinical manifestations of tuberculous inflammation depend on the localization
specific process, the volume of lesions, presence of complications, the child's age and
comorbidities. The disease usually occurs gradually, but
complications during the beginning can be acute.
Symptoms observed less than half the children, and some may
absent. The most common are fatigue and lack of
appetite, weight loss, cough, unexplained or long continued fever,
not declining in the treatment of a wide range of BPO. In engaging in the process
pleural patient complains of chest pain. With the spread, atelectasis
appears short of breath.
From the local characteristics of tuberculosis often occur increased
peripheral lymph nodes (axillary, cervical, occipital elbow).
To exclude extrapulmonary localization should pay attention to the state
joints, spine, central and peripheral nervous system.
6.3 Identification and diagnosis of tuberculosis in children
58
Diagnosing TB in children is difficult, as children, tuberculosis
lungs, coughing and rarely emit virtually no phlegm.
Detection and diagnosis of tuberculosis based on the results of medical history, clinical
symptoms, bacteriological and radiological studies, the results
Mantoux test.
6.3.1 Medical history of the disease. If any child tuberculosis likely
presence in the family adult TB patients with bacterial. Therefore, in families where
revealed a sick child should take an active search for cases
tuberculosis.
6.3.2 Culture methods. Young children usually swallow
saliva and can not provide sputum for analysis. In this case, is collected
gastric lavage or throat swabs using a tampon. Unfortunately
it is unpleasant for the child.
Terms of collecting samples of material for research:
• Material should be collected daily for 3 days and timely delivery
the laboratory for analysis
• For best results, material from the stomach of the child should
extract immediately after awakening for the content,
accumulated during sleep. Smear from the pharynx should be collected and directly
morning with a tampon. Gastric material is more effective in diagnosing
tuberculosis than the swab from the throat. Timely treatment of gastric
material, since mycobacteria can not survive long in the acidic environment.
• In older children inhaling saline through a mask for 15-20
minutes may help sputum.
6.3.3 X-ray study (fluorography)
Tuberculosis in children is accompanied by intrathoracic lymphadenopathy, most
bronchopulmonary lymph nodes increased (70-90%). Enlarged lymph nodes
better seen on lateral projections. An indirect sign of increased lymph
may be atelectasis (hypoventilation) segment or lobe.
Primary tuberculosis in children may be accompanied by exudative pleurisy.
In miliary tuberculosis detected rash in all lung fields, but
early stages it may not be visible.
6.3.4 Mantoux test (objectives, indications, contraindications, assessment)
Purpose - to identify persons infected with Mycobacterium tuberculosis.
Characteristics of tuberculin. For the Mantoux test with 2 TE using
purified tuberculin in standard dilutions PPD-L 2m (purified protein derivative
- Purified protein derivative, L-Linnikovoy).
Indications for the Mantoux test.
• preventive examination of children from groups of "risk" of foci of tuberculosis
• selection of children older than 2 months for the BCG vaccination and revaccination.
59
Mantoux skin test conducts prescribed by a doctor specially trained medical
sister, having a document-tolerance to this procedure.
In order to select children for revaccination BCG, Mantoux test with 2 TE put children in
aged 6-7 years in school in the first month of the school year (September). During this period
Other vaccinations should not be conducted.
Disorganized children early and preschool age Mantoux test is put in
children's clinic in the rural areas - a network of primary health care (clinic, medical
dispensaries, health posts).
Contraindications to the formulation of Mantoux test
• acute and chronic infectious diseases
• physical conditions (including epilepsy) in acute
• allergic conditions, rheumatism, in acute and subacute phases, bronchial
asthma, idiosyncrasy with severe skin manifestations in acute
Mantoux skin test placed 2 months after the disappearance of clinical symptoms or
immediately after removal of the quarantine.
Conducting Mantoux test should be planned to carry out preventive
inoculations against various diseases (DPT, measles, etc.). Otherwise
Mantoux test may be conducted no earlier than 1 month after vaccination.
Evaluation of Mantoux test performed 72 hours later by measuring the cross
the size of infiltrate (papules) in millimeters (mm), in the absence of infiltration
measured and recorded hyperaemia.
• negative (anergy) - complete lack of infiltration (papules) or
hyperemia or the presence of ukolochnoy reaction (0-1 mm);
• questionable (gipoergiya) - infiltration of 2-4 mm or hyperemia
any size;
• positive (normergiya) - infiltration measuring 5 mm or more;
• strongly positive (giperergiya) - infiltration in children size 15 mm and
more in adolescents - 17 mm or more adults - 21 mm or more, as well as
vesicle-necrotic reactions regardless of the size of infiltration with
lymphangitis or without him.
Children in need in the differential diagnosis of post-vaccination and
Infectious Diseases Allergies are observed in the dispensary to "0"
control group.
With the exclusion of active tuberculosis of the infected children with superelevation
and hyperergic reaction observed for group III control.
The results of the Mantoux test are recorded in the map immunization (form
№ 063 / y) in the child's medical card (Form № 026 / y) in the history of child
(Form № 112 / y).
For the diagnosis of tuberculosis informative value of Mantoux test is relative.
It can not indicate the existence or extent of the damage tuberculosis organism.
A negative result does not exclude tuberculosis. However, hyperergic
60
reaction may serve as an additional indirect indication in favor of tuberculosis
etiology of the identified changes.
6.4 Treatment of tuberculosis in children
Treatment of TB in children is based on the general principles of chemotherapy of tuberculosis and
should
conducted in compliance with the duration, continuity, combined
appointment of more than three drugs, in accordance with standards adopted in the country.
Treatment of children and adolescents, regardless of clinical forms must start
hospital. Maintenance phase of treatment continues in
hospital, sanatorium or outpatient, depending on the severity of the disease and
socio-economic status of the sick child. However, outpatient
sick children in the support phase complicates the control of drug administration and creates
risk of interruptions in treatment.
Recommended treatment regimens and doses of drugs to treat TB in children are similar
those for adults. The use of ethambutol in young children in
recommended doses safe enough.
Doses of anti-TB drugs in the treatment of children are determined by the weight of
child, so in the process of chemotherapy dosages must
adjusted as changes in body weight.
In children with tuberculous meningitis should be used instead of ethambutol
streptomycin, ethambutol, as does not penetrate the blood-brain barrier.
In the treatment of tuberculous meningitis, tuberculous exudative pleurisy
etiology and disseminated tuberculosis are used corticosteroid
drugs on a background of ongoing antitubercular therapy as a means of
pathogenetic treatment.
6.4.1 Rekomenuemye doses of anti-TB drugs for children with
TB treatment in regimes I and III category
Table 7 - TAP Doses for children in the treatment of I-III categories
Intensive phase Maintenance phase
(Ethambutol or streptomycin for
choice)
daily intermittent
Officer
Weight
body to
start
treatment
(Kg)
H
100
mg
R
150
mg
Z
500
mg
E
400
mg
S
1 gram
H
100
mg
R
150 mg
H
100
mg
R
150 mg
5-10 1 / 2 1 / 2 1 / 2 1 / 2 150 mg 1 / 2 1 / 2 1 1 / 2
11-20 1 1 1 1 300 mg 1 1 2 1
21-30 2 2 2 2 450 mg 2 2 3 2
Note:
� doses for children, body weight which is less than 5 kg, should be appointed
the rate of: isoniazid - 5 mg / kg, rifampicin - 10 mg / kg.
� mode Category I priority ethambutol instead of streptomycin
� the selection of streptomycin number of doses should not exceed 60.
Streptomycin should not be used more than 2 months. Prolonging
intensive phase for more than two months of streptomycin, ethambutol replaced
61
� with heavy processes, when the ingestion is not possible, then H and R are introduced
parenterally at the rate of mg / kg body weight.
6.4.3 Rekomenuemye doses of anti-TB drugs for children with
treatment of tuberculosis in the mode II category
Table 8 - TAP Doses for children in the treatment of Category II
Intensive phase Maintenance phase
daily intermittent
Officer
Weight
body to
start
treatment
(Kg)
H
100
mg
R
150
mg
Z
500
mg
E
400
mg
S
1 gram
H
100
mg
R
150
mg
E
400
mg
H
100
mg
R
150
mg
E
400
mg
5-10 1 / 2 1 / 2 1 / 2 1 / 2 150 mg 1 / 2 1 / 2 1 / 2 1 1 / 2 3 / 4
11-20 1 1 1 1 300 mg 1 1 1 2 1 1,5
21-30 2 2 2 2 450 mg 2 2 1 3 2 2
Note:
� with a daily treatment regimen in the maintenance phase in a hospital
dosage TAP are the same as in the intensive phase
� number of doses of streptomycin should not be more than 60
6.4.4 Recommended doses of 3 - and 2-component combined
anti-TB drugs at fixed doses for children
Table 9 - Combined Doses of TAP for children
The initial phase Maintenance phase (tablets)
RH (60mg +30 mg)
Body weight of the patient
(Kg) RHZ
(60mg +30 mg +150 mg)
(Tablets)
daily intermittent
<7 1 1 1
8.9 1.5 1.5 1.5
10-14 2 2 2
15-19 3 3 3
20-24 4 4 4
25-29 5 5 5
6.4.5 Features of treatment of tuberculosis with complications
1) In tuberculosis of the bronchial and pulmonary lesions, along with
The main treatment is shown topical treatment - introduction of TAP in aerosols and
intratracheal (endobronchial). Older children and adolescents with
proliferation of granulation affecting bronchial patency, shown
cauterization of granulation tissue.
2) When limfonodulobronhialnyh fistulas, along with local treatment,
advisable, if possible, repeat bronchoscopy and try to remove
caseous masses to prevent violations of bronchial obstruction,
3) In order to accelerate reparative processes and preventing the development
62
fibrosis in all the complicated processes at tumoroznyh forms of tuberculosis
intrathoracic lymph nodes is advisable to apply: ultrasound
therapy, phonophoresis with hydrocortisone ointment 5.0%, with lidasa; electrophoresis
with broncholytics, 5 -% r-rum calcium chloride.
4) When exudative pleurisy shows the aspiration of pleural fluid with
subsequent studies of sediments throughout the evacuated fluid Office
by microscopy and inoculation. With the accumulation of fluid needed
repeated aspiration.
5) In destructive forms of tuberculosis in older children (from
12 years) and adolescents in order to accelerate the closure of the cavity decay appropriate
application kollapsoterapevticheskih treatments - Artificial
pneumothorax and pneumoperitoneum (5-10 treatments).
6) For failure of chemotherapy in cases of large conservation
tumoroznyh lymph nodes, the formation of large tubercles and
kazeomy pleura, with no tendency to heal cavities recommended
surgical treatment.
In tuberculosis in children and adolescents are rarely found mycobacterium,
therefore translate the supporting phase of treatment should be carried out
Based on clinical and radiological improvement process.
With the spread, with bilateral localization, including
destructive changes in lung complications during and in
miliary tuberculosis of the intensive phase of treatment of patients with new cases
TB is carried out within four months (I category of treatment) with repeated
TB cases - five months (II category of treatment). In children with small and
limitations of pulmonary and extrapulmonary TB without
MBT (III category of treatment) period of treatment in the intensive phase two
months.
The duration of the intensive and maintenance phases of treatment for all categories
TSVKK solved, according to the standard scheme.
6.4.6 Treatment of post-vaccination complications of BCG
6.4.6.1. Treatment of post lymphadenitis
Under infiltration appointed inside - isoniazid (H-5 mg / kg) treatment
performed on an outpatient or spa environment. Locally used
application: rifampicin (0,45 g) + 10% or 20% solution dimexide, 2 times a day
within 1 month. With the trend towards an increase in lymph node additionally
appointed ethambutol (E-15 mg / kg) + vitamin A. The duration of treatment - 2-4
months (individually, taking into account the dynamics).
In caseous-necrotic stage of treatment in the first 2 months of use
isoniazid (H - 5 mg / kg) + ethambutol (E-15 mg / kg) + vitamin A. Treatment may
performed in an outpatient, spa or in stationary conditions. In testimony
being lymph node puncture with aspiration of the contents and subsequent
introduction of streptomycin (15 mg / kg) + sirepar 0,1-0,3 ml (depending on the size
lymph node), 1-2 times a week, a course of 5-6 injections, taking into account dynamics.
After 2 months at the positive dynamics of the treatment lasts one drug
(H), with slow dynamics - the two drugs (H + E).
63
In the absence of dynamics within one month of treatment or swellings
up to 5 cm or more surgical treatment is indicated. After surgery
Chemotherapy continues to isoniazid, topically can be used
applications with rifampicin + 10% or 20% solution dimexide.
The total duration of treatment - 3-4 months.
In the stage of calcification of the lymph nodes measuring 10 mm or more are subject
surgical treatment.
If Calcinates in peripheral lymph nodes, irrespective of
sized, revaccination BCG - contraindicated?
6.4.6.2 Treatment of post abscesses
Inside appointed isoniazid (5 mg / kg) for 2 - 4 month period.
Local used applications rimfampitsina + 10% or 20% solution dimexide.
When the fluctuations shown aspiration of contents.
In the absence of positive dynamics (dispersal) shows abstsessektomiya
together with the capsule. After surgical treatment of chemotherapy continues
isoniazid (H) within 1 month.
6.4.6.3 Treatment of keloid scars
Treatment subject to large keloid scars, more than 1 cm and having a tendency to
increase. Locally held obkalyvanie 0,5% solution of hydrocortisone
emulsion with 0.5% novocaine 1 time per week tuberculin needles 5-6
places in the most thick keloid. Course of treatment 5-10 obkalyvany. Hydrocortisone
emulsion can be alternated with lidasa (dose of 64 units. for children over 12 years, and 32 units. for children 7-11 years). If carried out a course of treatment is not effective or re-started
growth of keloids, the treatment shown pirogenalom + lidasa, alternating with the latest
hydrocortisone. Pyrogenal injected intramuscularly daily, starting with 25
minimal pyrogenic dose (MPD). Within 10 days the dose gradually
increased to 150 MTD children and adolescents up to 200 MTD. Maximum dose
introduced before the end of the general course of treatment (30 injections), and then makes 3
week break in treatment. After that should make obkalyvanie rumen
lidasa a dose of 64 units. every other day. Total 10 obkalyvany. At 1, 4, 7, 10 days in one
syringe with lidasa injected 25 mg of hydrocortisone.
Surgical treatment of keloids is contraindicated, since it leads 1-3
months to relapse with the re-formation of keloids is 2-3 times larger than
before surgery.
To avoid formation of keloids after revaccination should be strictly
adhere to existing medical contraindications and to conduct
revaccination in compliance with the site of injection, not above the upper and middle
thirds of the skin shoulder.
64
6.4.6.4 Treatment of superficial ulcers
Locally applied isoniazid powder (powder). To prevent
secondary infection, its edges are treated with antibacterial ointment.
6.4.6.5 Treatment of lesions of the bone system (osteitis)
The treatment of BCG-osteitis determined by the physician-ftiziosteologom given
localization and extent of injury. In general, conservative treatment,
with inefficiency applied surgical treatment.
During treatment of complications of BCG vaccination to include other
vaccination is contraindicated, except
epidemiological situations.
65
7. TREATMENT OF TUBERCULOSIS
7.1 Basic principles of chemotherapy
7.1.1 Direct control treatment (NKL or DOT)
NKL - one of the important elements of the TB. NKL means that a person
controlling treatment, each time observing how the patient swallows the medication.
This helps ensure that the patient takes the necessary antidrugs in the correct doses and with the correct frequency. Treatment under
control prevents the development of drug resistance.
Medicines should be convenient for the patient, so the outpatient treatment
NKL conducts medical staff of PHC. Family members should not speak in
Role of controlling medication.
7.1.2 Strict adherence to standard chemotherapy regimens in accordance with
categories of patients
The standard treatment regimen of TB patients have the following advantages:
� Fewer errors in the appointment, resulting in reduced risk
development of MDR-TB
� simplifies the calculation of the need for TAP procedure for their procurement, distribution and
control of
� simplified staff training
� decreasing treatment costs
7.1.3 Carrying out the treatment continuously in two stages:
The first phase - an intensive phase to suppress the breeding
bacterial population and reduce its amount. In 85% or more of patients with
smear-positive sputum at the end of intensive phase should occur
conversion. Intensive phase is carried out mainly in the hospital, the possibility
outpatient or spa treatment is solved TSVKK;
The second phase - conducting maintenance phase in order to destroy the latent
forms of mycobacteria to prevent the development of recurrence in the future.
Maintenance phase is carried out mainly in the outpatient or spa
conditions in a daily or intermittent mode (3 times a week).
Ability to conduct maintenance phase of treatment in hospital solved TSVKK
(Typically, patients from socially disadvantaged, the poor
population).
NKL - the best way to prevent interruptions in treatment, but even if this may
observed in case of interruption of treatment. If the patient did not show up on your medicines
appointed day in the intensive phase, it should seek out the next day.
If the patient is in the maintenance phase, it should find for
week.
Patients who undergo treatment - it is a rather complicated task to solve
which must take into account various parameters: the results of treatment
microscopy data, the sensitivity of the Office.
66
The annex table "Measures taken at intervals in
treatment.
7.2 Aims of treatment
Treatment of TB patients is aimed at achieving the following goals:
• Cure TB
• Prevention of fatalities and severe complications
• Reducing the risk of relapses
• Reducing the spread of infection in the community
• Prevent development of drug resistance
7.3 The main anti-TB drugs, mechanism of action
Therapeutic effect of anti-TB drugs due
direct bactericidal activity and sterilizing effect on
pathogen, as well as the ability to prevent development of drug
resistance.
Isoniazid
Protivomikobakterialnoe tool. Available in tablets of 100 mg and 300 mg in
ampoules containing 5 and 10 ml of 10% solution (100 mg in 1 ml).
General information
Isoniazid - drug isonicotinic acid hydrazide (Ginko), high
bactericidal activity against actively dividing Office. Drug quickly
absorbed from the gastrointestinal tract and easily penetrates the tissue and
body fluids. The rate of inactivation of genetically
deterministic: the "fast inactivator" half-life of the drug from
plasma 1 hour, at the "slow inactivator" - 3 hours. The drug is usually
displayed by the kidneys during the day.
Application
Used as an essential component of all schemes TB
chemotherapy recommended by WHO. As monotherapy, the drug is carried out only
chemoprophylaxis contact.
Route of administration
Isoniazid is usually taken by mouth. Persons with severe specific
of the drug can be injected intramuscularly.
Contraindications
• Hypersensitivity to the drug;
• Acute hepatitis.
Adverse reactions
In general, INH is well tolerated.
Sometimes in the first week of treatment may cause allergic reactions in
a skin rash. Perhaps the development of peripheral neuropathy, which
can be removed by sanding pyridoxine. Hepatitis is rare, but is
serious complication. The severe consequences of hepatitis can be prevented
Cessation of drug treatment and the appointment of detoxication therapy.
67
Rifampicin
Protivomikobakterialnoe tool. Available in capsules, tablets and capsules 150
and 300 mg.
General information
Rifampicin is a semisynthetic derivative of rifampicin, an antibiotic from
macrolide that inhibits the synthesis of RNA, has expressed
bactericidal activity and sterilizing pronounced effect in relation to
Office located on the extra-and intracellularly. When receiving the drug is rapidly absorbed
and penetrates into all tissues and body fluids. When inflammatory changes
meninges drug penetrates into the cerebrospinal fluid. With single
medication peak drug concentration is achieved in 2-4 hours, the period
half-life of 2-3 hours.
At rifampicin easily develop resistance, so it should appoint
in combination with other anti-TB drugs.
Application
Used as an essential component of all schemes TB
chemotherapy recommended by WHO.
Route of administration
Rifampicin is recommended to take at least 30 minutes before eating. Persons with
severe specific process the drug can be intravenously
drip.
Contraindications
• Hypersensitivity to the drug;
• Violations of liver function.
Adverse reactions
In general, rifampicin is well tolerated.
Sometimes at the beginning of treatment may be a moderate increase in bilirubin levels and
transaminases in the serum. The possibility of severe disorders of the gastrointestinal tract,
requiring discontinuation of the drug. Flu-like syndrome, fever,
thrombocytopenia, hemolytic anemia, skin rashes occur in the treatment
from intermittent pattern. Hepatitis is rare.
Pyrazinamide
Protivomikobakterialnoe tool. Available in tablets of 400 mg.
General information
Synthetic analogue of nicotinamide, which has weak bactericidal activity
against M. tuberculosis, showed pronounced sterilizing effect in
acidic medium.
The drug is readily absorbed from the gastrointestinal tract and rapidly penetrates into all tissues and
biological
fluids. Peak drug concentration in plasma achieved
2 hours after admission, half-life of 10 hours.
Application
It is used in the intensive phase of all the schemes of TB chemotherapy,
recommended by WHO.
Dosage and administration
Pyrazinamide ingest a dose of 25 mg / kg daily, 35 mg / kg 3 times a week.
Contraindications
• hypersensitivity to the drug;
68
• Severe liver injury.
Adverse reactions
Pyrazinamide may cause adverse reactions on the part of the digestive system.
Sometimes at the beginning of treatment may be a moderate increase in transaminase level
serum. Cases gepatitotoksichnosti rare. Sometimes developing gout
corrective allopurinol. Often may have arthralgias,
cropped analgesics.
Streptomycin
Protivomikobakterialnoe tool. Available in powder for injection, 1 g
(Sulfate) in vial.
General information
Streptomycin is an aminoglycoside antibiotic produced by
Streptomyces griseus.
After intramuscular injection of the drug penetrates the intercellular space
all tissues of the body. Small amounts of the drug penetrates the cerebrospinal
liquid. The half-life is 2-3 hours.
Application
It is used as a component of all schemes of TB
chemotherapy recommended by WHO.
Route of administration
Streptomycin should be entered by deep intramuscular injection.
Contraindications
• Hypersensitivity to the drug;
• Diseases of the auditory nerve;
• myasthenia gravis.
Adverse reactions
Hypersensitivity reactions are rare. But if they arise,
drug should be abolished and a desensitizing therapy. From toxic
reactions may be impaired hearing and kidney function.
Ethambutol
Protivomikobakterialnoe tool. Available in tablets of 100 and 400 mg.
General information
The synthetic analogue of 1,2-etandiamina with weak bactericidal
activity against M. Tuberculosis and other mycobacteria.
The drug is readily absorbed from the gastrointestinal tract and rapidly penetrates into all tissues and
biological
fluids. Peak drug concentration in plasma achieved
2-4 hours after administration, half-life of 3-4 hours.
Application
He is one of the possible components of schemes TB
chemotherapy recommended by WHO.
Route of administration
Ethambutol ingest a dose of 15 mg / kg daily, 30 mg / kg 3 times a week.
Contraindications
• Hypersensitivity to the drug;
• optic neuritis;
• creatinine clearance less than 50 ml / min.
69
Adverse reactions
In the treatment of ethambutol in large doses can develop optic neuritis.
Sometimes developed neuritis of the lower extremities.
Table 10 - Recommended dose of TAP
The drug activity recommended dose
daily 3 times
week
Isoniazid Action on fast and slow
multiplying the Office
located extra-and intracellular
5 (4-6) 10 (8-12)
Rifampicin effect on the fast and slow
multiplying the Office, especially
slowly multiplying
located extra-and intracellular
10 (8-12) 10 (8-12)
Effects of pyrazinamide in acid medium on
vnutikletochno located Office
25 (20-30) 35 (30-40)
Streptomycin action to the fast-multiplying
Office, located extracellularly
15 (12-18) 15 (12-18)
Ethambutol Effect on Office, located offand intracellular
15 (15-20) 30 (20-35)
The greatest bactericidal activity is isoniazid and rifampicin,
are active against all populations of the Office. Of the existing drugs
the greatest sterilizing activity is rifampicin. Pyrazinamide and
Streptomycin bactericidal effect on the part of the mycobacterial population.
Pyrazinamide is active only in acidic medium. Ethambutol is used in conjunction with
more active drugs to prevent development of drugSustainable Office.
Table 2 presents data on the dosage forms of TB
preparations of the basic series and the content of the active substance.
Table 11 - Pharmaceutical form and dosage of BOL basic series
Name
drug
Dosage form content
actant
Isoniazid (H), tablet, ampoule 100 mg, 300 mg
Rifampicin (R) tablet, capsule or ampoule 150 mg, 300 mg
Pyrazinamide (Z) tablet 400 mg, 500 mg
Ethambutol (E) tablet 100 mg, 400 mg
Streptomycin (S) powder for injection, 1 g vial
Table 3 shows the daily doses (mg) of TB
preparations of the basic series of intensive and supportive phases.
Table 12 - Daily dose (mg) of antituberculosis drugs for adults
70
Name Weight (kg)
preparation 30-39 40-54 55-70 over 70
Intensive phase - a daily intake
Isoniazid 200 mg 300 mg 300 mg 400 mg
Rifampicin 300 mg 450 mg 600 mg 750 mg
Pyrazinamide 1000 mg 1500 mg 2000 mg 2000 mg
Ethambutol 600 mg 800 mg 1200 mg 1600 mg
Streptomycin 0,5 0,75 1,0 1,0
Maintenance phase - a daily intake
Isoniazid 200 mg 300 mg 300 mg 400 mg
Rifampicin 300 mg 450 mg 600 mg 750 mg
Ethambutol 600 mg 800 mg 1200 mg 1600 mg
Maintenance phase - reception 3 times a week
Isoniazid 300mg 600mg 600mg 700mg
Rifampicin 300mg 450mg 600mg 750mg
Ethambutol 1200mg 1600mg 2400mg 2400mg
Note: The maximum daily dose of rifampicin in FDC - 750 mg.
Combined anti-TB drugs
fixed-dose
Combined anti-TB drugs fixed-dose
(FDC) have several advantages compared with monocomponent.
Preimushestva:
• Reducing the probability of errors in the appointment due to a more precise
recommendations for dosing adjustments and simplification of dosage
according to the weight of the patient.
• Reducing the number of tablets that promotes better compliance
patients assigned chemotherapy.
• Taking drugs is carried out simultaneously under the direct supervision.
Patients are unable to take drugs selectively.
Table 4 gives information about the most commonly used drugs
forms of FDC and the content of active substances in the preparation for the daily and
intermittent reception.
Table 13 - Combined anti-TB drugs with fixed
doses (FDC)
The content of active substances (in mg)
reception:
Name
drug
Medication
form
daily 3 times a week
Isoniazid +
Rifampicin
Tablet
Tablet
75 mg + 150 mg
150mg + 300mg
150mg + 150mg
Isoniazid +
Ethambutol
Tablet 150mg + 400mg + Isoniazid Tablets 75mg +150 mg + 400mg 150mg +150 mg +
71
Rifampicin +
Pyrazinamide
500mg
Isoniazid +
Rifampicin +
Pyrazinamide +
Ethambutol
Tablet 75mg +150 mg +
400mg +275 mg
7.4 Side effects of antituberculosis drugs and their management
Most TB patients complete treatment without any serious
adverse reaction to anti-TB drugs. However, some
patients with such reactions may occur, so in a timely manner
detection and elimination of adverse reactions should be clinical observation
all patients. Health workers can themselves monitor the side
reactions or to teach patients to recognize the most common side
reaction time and report them to the doctor, or ask questions about the patient
tolerability of treatment with direct conversation.
Adverse reactions may be minor in the form of discomfort and
expressed, which may lead to severe dysfunction of hearing, vision,
brain, kidney or liver. In the presence of hypersensitivity reactions to the system and
local symptoms, but without the threat of life, the usual approach - is to abolish all
anti-TB drugs and to allow the patient to return all tests
to the original level. Then the patient can be consistently one TAP
assessing symptoms, objective signs and laboratory tests.
If local skin reactions should not automatically stop the therapy.
It should reassure the patient and apply the symptomatic treatment, while continuing to receive
antituberculosis drugs. Against the background of the symptomatic treatment of local rash
time is reduced.
The most frequent response to TB treatment - gastro-intestinal,
manifested in the form of gastritis and removed the appointment TAP after a meal or
with antacids, the separation taking different drugs at the time or method
particular drug twice instead of once a day.
Side effects when receiving TAP can be caused by the influence of alcohol,
pregnancy, increased intracranial pressure, diseases of the gastrointestinal
intestinal tract, gallbladder and pancreas are allergic to food
products, other medicines.
7.5 Categories of treatment, prescribing scheme
Treatment of patients with tuberculosis should be in standard modes of
according to the categories
Table 14 - Standard chemotherapy
Category Intensive phase Maintenance phase
I 2 (4) HRZE (S) Streptomycin
used within 2 months
4 (7) H3R3 or
4 (7) HR or 4 (7) HRE *
II 3 (5) HRZES Streptomycin is used
2 months
5 H3R3E3 or 5 HRE
III 2 HRZE 4 H3R3 or 4 HR or 4HRE *
Note: The number before the letters indicates the duration of the phase in months. Subscript
figures indicate the number of doses per week. If the letters are no numbers, this means that
the patient must take medication daily. Alternative medicine is indicated in parentheses.
* This regimen is appointed by the presence monoresistance to isoniazid and rifampicin.
Standard chemotherapy treatment include new patients and
re receiving treatment. Patients receiving TAP earlier than 1 month
are likely to have drug resistance. Such patients admitted to
intensive phase of 5 drugs and supportive - 3 of the drug. Throughout
rate they receive isoniazid (H), rifampicin (R) and ethambutol (E). This scheme
can cure patients with preserved sensitivity to drugs of Office
main number or the presence of resistance to H and / or S.
7.5.1 Treatment of patients with category I
Intensive phase is conducted in the period from 2 to 4 months, depending on the severity and
prevalence of tuberculosis process. Prior to treatment, all patients
pulmonary tuberculosis should be sputum culture with DST
Mycobacterium tuberculosis to anti-TB drugs.
Treatment should be carried out by four drugs: isoniazid (H), rifampicin
(R), pyrazinamide (Z), ethambutol (E) or streptomycin (S) in the corresponding
weight dosage. Streptomycin should be used no more than 2 months.
After 2 months of the transition to the maintenance phase of treatment is possible in the case
negative result of double research smear at the Office.
If the end of the 2 month smear remains positive, it is necessary to rerun
DST and prolong the intensive phase for 1 month. Upon receipt of a negative
result of double research smear at the end of 3 months, the patient should
be transferred to the supporting phase of treatment.
If at the end of 3 months of smear remains positive, the intensive phase
should be extended for 1 month. When a negative result
double research smear at the end of 4 months, the patient should be
transferred to the supportive phase of treatment.
If at the end of 4 months or in the maintenance phase of stroke remains positive, then
the patient is determined by the outcome of "failure of treatment. When the stored sensitivity
73
Office of TAP patient re-registered for treatment in the mode II category. At
there polyresistance patient determined outcome "treatment failure" and
patient should be re-registered in the register of patients
Tuberculosis category IV (TB 11). The choice of treatment re-treatment
decides TSVKK, the patient may be the appointment of second line drugs.
If the patient has confirmed multidrug resistance,
irrespective of the effectiveness of the I category, he transferred to the category IV and
the outcome of his treatment should be defined as "Transferred to the category IV». After
re-registration in Category IV with a positive effect of treatment on mode I
category (conversion of smear, positive clinical X-ray
dynamics), the patient continued treatment for this category.
In the absence of positive clinical and radiological improvement in patients with
negative results of microscopy, it is necessary to resolve the issue of TSVKK
the possibility of appointing a standardized patient treatment drugs
second row.
Maintenance phase should take place within 4 months of two drugs
isoniazid (H) and rifampicin (R) in daily or intermittent mode.
If monoresistance to isoniazid (H) or rifampicin (R) appointed
Three TAP - isoniazid (H), rifampicin (R) and ethambutol (E). Treatment is only
on a daily basis to address TSVKK. In severe cases
maintenance phase can be extended to 7 months only on a daily basis.
Number of doses taken by patients with category I in the application
monocomponent ("loose") drugs should be:
In the intensive phase for 2 months - 60 doses, for 3 months - 90 doses, for 4 months - 120 doses.
In the maintenance phase in the intermittent mode, for 4 months (17 weeks) - 54
doses for 7 months (30 weeks) - 90 doses. With a daily basis the patient should
receive TAP 6 times a week. Thus, for 4 months the patient should receive
108 doses, for 7 months - 180 doses.
In applying the standard sets of treatment (whales) to follow instructions
attached to the whales.
74
7.5.2 Treatment of patients with category II
The intensive phase should be conducted in terms of 3 to 5 months (inclusive), in
Depending on the severity and prevalence of tuberculous process. Prior
treatment is necessary to culture sputum with DST.
Within 2 months of treatment is five drugs: isoniazid (H),
rifampicin (R), pyrazinamide (Z), ethambutol (E) and streptomycin (S) in
respective weight dosages. Then the treatment lasts four drugs:
isoniazid (H), rifampicin (R), pyrazinamide (Z), ethambutol (E), without
streptomycin.
After 3 months, in the case of a negative result of double stroke study
sputum for the Office, the patient is transferred to a supporting phase of treatment.
If by the end of 3 months of stroke remains positive, it must reto DST and prolong the intensive phase for 1 month. Upon receipt
negative result of double research smear at the end of 4 months,
patient should be transferred to a supporting phase of treatment. If the end of 4
month smear remains positive, the intensive phase should extend
1 month.
Patients with negative results twice studies smear in
end of 5 months translated into supportive phase of treatment.
If at the end of 5 months or in the supporting phase is determined by positive
stroke, the patient is determined by the outcome "treatment failure" and he is in the IV
category. After the re-issue of the mode of treatment solves TSVKK.
If DST results confirm the presence of multidrug
sustainability (multiresistance) until the end of intensive phase of the patient
regardless of the efficiency obtained with treatment (II category) should be
transferred to the category IV, and the outcome of his treatment is defined as "Transferred to
Category IV ».
After re-registration in the category IV, the patient with the positive effect of treatment in
Mode II category (conversion of smear, positive clinical
X-ray dynamics) must continue treatment for this category. At
negative effect of treatment, or lack thereof TSVKK must decide
the possibility of treatment with some contingency.
Maintenance phase must be done within 5 months of the three drugs
isoniazid (H), rifampicin (R) and ethambutol (E) intermittent (3 times
week) or daily basis.
Number of doses taken by patients with category II in the application
monocomponent ("loose") drugs should be:
In the intensive phase for 3 months - 90 doses, for 4 months - 120 doses, for 5 months - 150 doses.
In the maintenance phase in the intermittent mode for 5 months (22 weeks) - 66
doses on a daily basis (6 times a week) - 132 doses.
In applying the standard sets of treatment (whales) to follow instructions
attached to the whales.
75
7.5.3 Treatment of patients with category III
The intensive phase of treatment should be done within 2 months of 4 drugs:
isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E). Prior
treat all patients with pulmonary tuberculosis should be culturally
sputum with the DST of Mycobacterium tuberculosis to antidrugs.
After 2 months in the case of a negative result of double research
smear on a patient is transferred to the Office supports the phase of treatment. If
end of intensive phase, or in the supporting phase the patient is found
mycobacterium, he determined the outcome "treatment failure" and the patient
re-registered for treatment in the mode II category.
If the patient is confirmed polyresistance, it must be
re-registered in the register of patients with tuberculosis category IV (TB 11).
After the re-issue of the mode of treatment and the possibility of
solves a number of contingency preparations TSVKK.
If the patient is confirmed multidrug resistance
(Multiresistance), then regardless of the effectiveness of the Category III patient
translated into the category IV, and the outcome of his treatment is defined as "Transferred
Category IV ». After re-registration in the category IV, the patient who has a
Positive clinical and radiological improvement, continue treatment for this
category. If treatment is not effective for Category III (MBT appeared
after 2 months or more, there is no positive clinical X-ray
dynamics), it is necessary to consider the possibility of appointing a patient TSVKK
treatment with some contingency.
Maintenance phase in patients with Category III shall be performed within 4 months in two
drugs: isoniazid and rifampicin in intermittent or daily
mode. In identifying monoresistance to isoniazid or rifampin before
maintenance phase of treatment is carried out with the addition of ethambutol.
Number of doses taken by patients with category III in the application
monocomponent ("loose") drugs should be:
In the intensive phase for 2 months - 60 doses.
In the maintenance phase in the intermittent mode, for 4 months (17 weeks) - 54
dose on a daily basis (6 times a week) - 108 doses.
In applying the standard sets of treatment (whales) to follow instructions
attached to the whales.
7.5.4 Treatment of tuberculosis in special cases
Pregnancy. Before TB treatment need to know about possible pregnancy
patient. If such a patient should explain the possibility of successful
tuberculosis. Most anti-TB drugs are not
risk to the fetus. The exception is streptomycin, which for the future
Child is ototoxic medication, and therefore it should not be
76
used in treatment regimens.
Breastfeeding TB patients, women, nursing babies,
should receive a full course of TB chemotherapy. Timely and
correctly chemotherapy isoniazid for 3 months - this
the best way to prevent transmission of the Office of mother to child. Vaccination
neonatal BCG vaccine is postponed until the end of the course
isoniazid chemoprophylaxis.
Disorders of liver function. Of the 3 anti-TB drugs (isoniazid,
rifampicin, pyrazinamide) with hepatotoxic effects, most
is the risk of pyrazinamide. It should be noted that the above drugs
can be used in patients with impaired liver function in the absence of
clinical manifestations of chronic liver disease (chronic carrier
hepatitis, acute hepatitis in the past, alcohol abuse).
Chronic liver disease. Patients with chronic liver disease is not
treatment regimens should receive pyrazinamide. To treat such patients in
8 months of isoniazid and rifampicin, and add one or two
drug, non-hepatotoxic effect (or streptomycin
ethambutol). 9 RE or SHE in the intensive phase and HE - in the supporting phase. Total
The entire course of treatment 12 months. Alternative scheme: 2 SHRE /
9RE, 2 SHRE / 10 IE.
Acute hepatitis. With the development of acute hepatitis in tuberculosis treatment can be deferred,
not yet resolved acute phenomenon. If you can not postpone treatment
chemotherapy is safe combination of SE during 3 months until
resolved acute hepatitis, then in the maintenance phase for 6 months the patient
may receive isoniazid (H) and rifampicin (R). If hepatitis B is not eliminated
general SE treatment should be 12 months.
Renal failure. In renal insufficiency, isoniazid, rifampicin and
pyrazinamide can be given in standard dosage. In severe
renal failure patients with isoniazid should be prescribed
pyridoxine to prevent peripheral neuropathy. Streptomycin and ethambutol
should be prescribed in lower dosages. The safest method of treatment of such
patients: 2HRZ / 4 HR.
HIV infection. In general, chemotherapy regimens for infected and
HIV-uninfected patients with tuberculosis are the same. When properly
sterilization of needles and syringes, the use of chemotherapy with streptomycin
possible. In the treatment of HIV-infected pregnant women should
consideration of antiviral therapy in combination with
TB treatment.
7.6 The control (monitoring) of treatment
In the course of treatment is required to monitor the effectiveness of treatment and
monitoring of side effects of drugs.
77
Monitoring the treatment of TB patients with positive sputum smears
based on studies of sputum. Following the appointment of the default mode
chemotherapy, microscopic examination of sputum performed at the end
intensive phase, at 5 months (maintenance phase) and at the end of treatment. At
This material is collected without interruption of treatment.
Patients with TB-negative sputum smears and patients with extrapulmonary
Tuberculosis treatment efficacy assessed by clinical and radiological
data.
Culture investigations are used in treatment failures to identify
drug sensitivity of MBT to TAP.
7.6.1 Monitoring of adverse reactions in the treatment of TAP
Most TB patients complete a full course of treatment without any serious
adverse reactions to TAP. But some they can be observed, so for all
patients should be clinically monitored for early detection and
eliminate adverse reactions. You can teach patients to recognize the symptoms often
occurring adverse reactions, or to interview patients about the presence of
symptoms.
7.7 Cohort analysis of the TB program
Cohort analysis is part of evidence-based medicine and allows
objective analysis of the data for the dynamic and the final assessment of the implementation
Tuberculosis Programme. Cohort analysis - is the main tool for assessing
effectiveness of national programs to combat TB. It allows you to identify
problems on which the national TB program could
take measures to overcome them and improve efficiency.
Cohort - a group of patients, combined one common feature,
registered for treatment during a certain time
(Usually during the quarter).
To assess the progress of the WHO TB program uses three basic
cohort of patients with pulmonary tuberculosis:
Cohort 1 - "new" cases of MBT
Cohort 2 - BK + cases that had previously been cured, but again became ill (relapses)
Cohort 3 - BK + cases that had previously been treated, but were not treated (failure
treatment)
These three cohorts provide basic information for management in order
assess the progress of each cohort of patients, and the identification and correction
problems that may arise and, in turn, lead to poor performance
cure.
Cohorts of cases should never be mixed, as this will destroy the basic
information for management and not give an objective assessment of the TB program.
78
New cases and previously treated for different patients formed the cohort, as they
characteristics and expected results of treatment vary.
Typical cohort includes new cases of pulmonary TB smear positive
sputum, registered during the quarter. Assessment of treatment outcomes of new
patients with pulmonary tuberculosis with positive sputum smears is
the main indicator of the quality of TB programs. Analysis of outcomes in other
patients (re-treatment pulmonary TB smear-negative, extrapulmonary TB)
performed on separate cohorts.
National TB program evaluates treatment for
following cohorts of patients with TB:
• New smear positive
• Setbacks
• treatment failure
• Treatment after interruption
• New cases of smear-negative
• Extrapulmonary tuberculosis
• Transferred to the category IV
• Other
Assessment of treatment outcomes, and monitoring trends in indicators should
conduct at all levels - district, regional and national.
Cohort analysis should be conducted quarterly and year-end. Outcomes of treatment
evaluated after the entire cohort to complete treatment. Info
cohort analysis is made in the form of quarterly reports. Regional
Coordinator collects quarterly reports on the outcomes of treatment in the district
focal points, add them and submit a consolidated report in NTSPT. Next NTSPT
examines reports on cohort analysis of outcomes of treatment of TB patients in
national level, evaluates the data and develops recommendations.
Empyema surgery applies regardless of
and the prevalence of bacteria.
Presence or absence of bronchial fistula does not matter.
Duration of surgical treatment (drainage) - held since the establishment of
diagnosis.
Type of surgery - torakotsentez, drainage of Byulau.
7.8.3.1.3 Postoperative chemotherapy:
Surgical treatment of patients with category I may be applied in any period
chemotherapy.
If the operation is performed in the intensive phase, it can be extended to
the maximum period - 4 months, after which the presence of smear conversion
the patient should be transferred to the supporting phase. Failing
Conversion or absence of positive dynamics of the patient with the outcome of "failure
treatment "should be translated into category II in preserved sensitivity
MBT to TAP the first row. In the presence of multiple (multiresistance,
polyresistance) drug resistance must be patient
reregister in TB 11 to category IV, and further treatment strategy defines
TSVKK.
If the operation is carried out in the supporting phase, it can be extended to 7
months, according to the standard scheme. In the case of the Office of milestones,
patient with the outcome "treatment failure" should be translated in the II category.
7.8.3.2 II category
Surgical treatment of patients subject to the following:
• with a poor outcome of treatment for Category I
• with recurrent tuberculous process
This category is characterized by a heavy contingent of patients with
torpid-current tubercular process. Features chemotherapy
application for 5 antimicrobial drugs in the treatment regimen to
cure is much limited, in connection with the identification of this period have
majority of patients resistant to 2 or more major antibacterial
drugs. But despite this, still have some of them, with strict indications can
successfully carry out surgical treatments.
In the medical category II surgical treatment is indicated in patients with volume
prevalence of lesions within one lung and not expelled
isolated foci of seeding in the opposite lung.
In patients with "poor outcome" prompt treatment is indicated in
the following clinical forms of pulmonary tuberculosis:
• cavernous tuberculosis
• Fibrous-cavernous tuberculosis
• focal, infiltrative and disseminated pulmonary tuberculosis with the outcome in
cavern
• Primary tuberculosis complex
• Tuberculosis of intrathoracic limfuzlov
• Complications of tuberculosis process (pleural effusion, pulmonary
bleeding, empyema, spontaneous pneumothorax)
84
• The surgical treatment of cavernous tuberculosis used in the presence of
isolated, thin-walled cavity in one or two segments of one lung,
smear, with preserved sensitivity and the absence
X-ray inverse dynamics of
Duration of surgical treatment resolved after 2 months of intensive phase
chemotherapy in the mode II category.
Types of surgical interventions for this group of patients: segmental resection,
lobectomy, torakomioplastika.
� In fibro-cavernous tuberculosis should bear in mind that these patients
found in filthy conditions and chemotherapy for Category I was
ineffective. With this in mind in the treatment regime II category,
need as quickly as possible to stabilize the tuberculous process and
only then apply to this category of patients with surgical methods of treatment
as further possible to change the group chronically ill. Surgical treatment
in these cases will be patients with a single cavity or multiple
cavities (polikavernoz) with a thick fibrous wall (capsule), occupying
limits of one share of possible dense centers around, with
bacterial or without him.
Timing of surgical treatment are solved in the presence of conservation of medicinal
sensitivity after 2 (3) months of intensive phase of treatment;
� In the presence of a single large cavity or polikavernoze one lung
foci of bronchogenic dissemination within this light, regardless of
bacteria.
Timing of surgical treatment are solved in the presence of conservation of medicinal
Sensitivity - after 3 (4) months of intensive phase of treatment. In this group
patients are often detected in sputum Office resistant to the main series and BPO
chemotherapy is necessary to reserve a number of drugs, respectively
sensitivity of the Office of ABP (see IV C)..
Types of surgical treatment - pneumonectomy, lobectomy, bilobektomiya,
torakomioplastika, transsternalnaya occlusion of the main bronchus.
� Primary tuberculosis complex in cases when the process acquires the character
chronic relapsing course and is complicated by the formation of
tuberkulomy or cavities in place of pulmonary component, segment or atelectasis
share tumoroznogo bronhoadenita treatment should be completed expeditiously
way.
Date of surgical treatment resolved after 2 months of intensive phase of treatment
Mode II category.
Types of surgical interventions - segmental, combined resection, in
combined with limfonodulektomiey.
� Tuberculosis of intrathoracic lymph nodes. Indications for surgical treatment
arise in cases of violation of bronchial obstruction segment, the share
lung or the occurrence of broncho-glandular fistulas with the threat of contamination.
Timing of surgical treatment resolved after 2 months of intensive phase of treatment
Mode II category.
Types of surgical treatment - limfonodulektomiya.
85
In patients with recurrences of pulmonary tuberculosis with antibacterial efficacy
treatment is much lower compared with the treatment of new cases. Indications for
surgical treatment are polikavernoz cavity or within a single lobe,
formed after a recurrence or focal infiltrative tuberculosis with
the presence of bacteria or without, with preserved sensitivity to the Office BPO
basic series, the termination of positive radiological improvement and
absence of infiltrations and focal dissemination around.
Timing of surgical treatment are resolved at the end of intensive phase (5 months)
treatment by regime II category.
� Caverna or polikavernoz with bronchogenic dissemination within a
infiltrative pulmonary tuberculosis, smear and
preserve the sensitivity to the main TAP.
Timing of surgical treatment should be planned for the end of 5 months of intensive
Phase II category.
Types of surgery - lobectomy, pneumonectomy, corrective or
Therapeutic torakomioplastika, transsternalnaya transperikardialnaya occlusion
main bronchus (TTOGB).
7.8.3.2.1 Complications of tuberculous process for recurrences and adverse
outcomes:
Clinical forms of pulmonary tuberculosis in which there are complications in
this phase of chemotherapy, are the same shape as that of complications in patients with I
category. A special feature is that they occur against a background of chronic,
torpid-tuberculous process and the current chemotherapy primary
disease is inefficient, due to the presence of resistance of MBT to the first TAP
series. In these cases, chemotherapy is necessary to carry out second line drugs
(See cat. IV.)
Timing of operative treatment - from the moment of diagnosis.
Types of surgical interventions:
• When spontaneous pneumothorax - torakotsentez, drainage of Byulau;
• When empyema with bronchial fistula with or without - torakotsentez, drainage
on Byulau. After reaching reorganization in empyema held
surgical interventions on the underlying disease that caused
complication (decortication, pneumonectomy, resection, TMPL)
• If pulmonary hemorrhage (after the source of bleeding) turnstile lobe bronchus ligation, the vessel with the lung parenchyma;
transsternalnaya occlusion of the main bronchus with ligation of the pulmonary artery
• When exudative pleurisy with the volume of fluid in the pleural cavity to
Level 4 intercostal space - torakotsentez, drainage of Byulau.
7.8.3.2.2 Postoperative chemotherapy
Surgical treatment may be applied in any period of chemotherapy with
available evidence.
In cases of surgical treatment in the period after 2 months of intensive phase, this
phase after the operation to extend to 5 months, inclusive, and then transferred to
supporting phase.
Patients in whom surgical intervention is applied to the end of intensive phase
(5 months) after surgery if conversion of sputum smears should be transferred
86
supporting phase II category. In the absence of conversion must
translate into the category IV and submit the patient to TSVKK to determine
further treatment tactics.
7.8.3.3 III category
Surgical treatment is indicated in the presence of tubercles small size without
signs of decay in the absence of bacteria, when the disease prevents
the work of the patient in their specialty.
Duration of surgical treatment is determined by the end of intensive phase.
Types of surgical interventions used in the above forms
Tuberculosis:
� Segmental resection or combined
� Precision resection
7.8.3.3.1 Postoperative chemotherapy - after the operation showed an
standard treatment regimens. If you find the Office in the postoperative period in
end of intensive phase, or in the supporting phase, the patient be transferred to
treatment failure in the II category.
7.8.4 Characteristics of surgical treatment in patients with advanced
forms of pulmonary tuberculosis
7.8.4.1. For common forms of pulmonary tuberculosis include:
� fibro-cavernous tuberculosis of one lung (polikavernoz, cavity) with
the presence of active changes in the opposite lung
� Caseous pneumonia is a lung
� Bilateral cavitary pulmonary tuberculosis (cavities in the upper lobes or
other combinations)
� Fibrous-cavernous tuberculosis in combination with pleural empyema with
bronchial fistula with or without
7.8.4.2 Types of operations are:
� Pneumonectomy, lobectomy, segmental resection or combined,
TTOGB after the compaction process of active change
opposite lung.
� In the presence of cavities in both lungs within a segment share - Bilateral
resection of the lobe, segmental resection.
� Depending on the condition of patients with possible one-stage resection. At
no signs of stabilization of a specific process and its
achievement can be applied in torakomioplastiku subpleural
location of caverns.
� When combined with pleural empyema should be adequate drainage (drainage
by Byulau). For these purposes should only be used with silicone tubes
diameter not less than 0,5 cm
� type operations torakostomiya "due to its low efficiency, requiring
further crippling multistage surgical interventions, used
in rare cases. It shows the presence of large diameter of bronchial
fistula, when the drainage pipe adequately.
87
� After reaching reorganization empiemnoy oral surgery recommended:
decortication, plevrektomiya with resection of the pathological focus,
combined intervention.
The basic condition for any surgical intervention in patients with a
stabilization of a specific process in the lungs
7.8.4.3 Contraindications:
� Drug resistance to all the main and backup BPO
� extensive destruction of lung tissue, leaving no room for choice
any surgical treatment
� Pulmonary heart with signs of decompensation
� amyloidosis of internal organs
� Acute and chronic liver disease and kidney function
deficiency
� Severe concomitant diseases: alcoholism, diabetes, congenital and
acquired heart disease with symptoms of decompensation, etc.
7.8.4.4. Features of the registration of patients after surgery
In cases of surgical intervention in patients with pulmonary tuberculosis in
period of chemotherapy in the mode of the intensive phase or maintenance phase of any
therapeutic category, after the end of postoperative chemotherapy, the registration
completion of treatment conducted in the same category, for which the patient
recorded at the beginning of chemotherapy.
Example:
� The patient was operated on NA after 3 months of intensive phase I
category. The clinical diagnosis before surgery: Infiltrative tuberculosis
right lung with the outcome of a tuberculoma, ILO (-). I category. Diagnosis after
surgery and postoperative chemotherapy: status after resection of the C1 +2
the right lung on the tuberkulomy, Office -. I category. Disinfected.
� The patient was operated on K. 2 months after completion of treatment of II
category, as in the lung preserved bladder changes. Clinical diagnosis
before the operation: Fibrous-cavernous tuberculosis of the upper lobe of right lung.
VC (-). II category. The diagnosis after the operation: post-upper lobectomy
the right lung on the fibro-cavernous tuberculosis. VC (-). II
category. Disinfected. In rare cases when indicated to
surgical treatment of patients following a standard course
chemotherapy with outcomes "cure" or "treatment completed" is defined by the type of
"Other" and assigned to treatment in the mode II category.
� Patient B. diagnosed with infiltrative tuberculosis of the upper lobe of the right
lung in the phase of disintegration, the Office + ", finished with a standard chemotherapy
outcome of "cure". After treatment, the patient remains CV size 3x5 cm
with fibrous walls. Patient surgical treatment is indicated. Clinical
diagnosis before surgery: Fibrous-cavernous tuberculosis of the upper lobe of the right
lung Office (-). Type "Other», II category. The diagnosis after the operation: Condition
after upper lobectomy of the right lung at the fibro-cavernous
tuberculosis. Office (-). Category II. Disinfected.
7.8.4.5. Clinical observation of patients with pulmonary tuberculosis after surgery
88
Clinical observation of patients after various types of operational
interventions should ensure continuity in the treatment of patients discharged from
surgical hospital. After the maintenance phase of chemotherapy
appropriate category of treatment should be observed in Group II dispensary
observation.
Of those with small residual changes: patients who had undergone pleural
pleurisy, segmental resections of tuberculomas, surgery for TB VGLU.
They should be seen within 1 year, and with great residual changes in
within 2 years.
7.9 Pathogenetic treatment
In the complex treatment of tuberculosis patients can be activated on
pathogenetic therapy, tasks which are:
• normalization of the functions of organs and systems, and development of tuberculous
process;
• elimination of inflammation in tissues, correction of reparative processes in tissues
to heal with minimal residual changes in the affected organs;
• The impact on the affected organs and the organism as a whole to improve
etiotrop treatment through the elimination of metabolic disorders and improve
immunological status.
Appointment of pathogenetic therapy requires proper technique
application and rigorous consideration of the individual characteristics of the organism, the nature of
process. It must be remembered that the pathogenetic funds should be appointed
against the background of TB chemotherapy, and not all at once.
7.9.1 Preparations and methods for the pathogenetic effects
7.9.1.1 Drug therapy medicines:
• immunocorrector (roncoleukin, Betaleukin, etc.);
• Drugs that have anti-inflammatory and desensitizing
action (prednisolone, calcium chloride, heparin, ascorbic acid,
diphenhydramine, suprastin, pipolfen, tavegil, diazolin, fenkarol);
• Enabling the processes of resorption and repair (etimizol, prodigiozan,
pirogenal, aloe, and a suspension of the placenta, retabolil, methandrostenolone, insulin,
lidasa);
• Improves metabolism, trophic tissues (kokarboksilaza, ATP,
methyluracil and vitamins);
• antihypoxants and antioxidants (Riboxin, sodium thiosulfate, vitamin E);
7.9.1.2 Non-medicated methods:
• Physical therapy: ultrasound, phonophoresis of hydrocortisone, electrophoresis in an ultrasonic
field. They increase the permeability of the tissue structures, inhibiting
fibrosis, improves the penetration of drugs in the lesions
(Lysing enzymes: chymotrypsin, lidasa, terrilitin and ultrasound, phonophoresis
hydrocortisone, electrophoresis in an ultrasonic field);
• Instrumental methods of treatment (plasmopheresis, hemosorbtion).
• Phytotherapy;
• Nutritsiologicheskie means (GMS, vegetable purée "Arman", Bilakt AU).
89
8. OFFICE OF MEDICAL SOFTWARE
Tuberculosis drugs
8.1 Purpose
Introduce modern management principles medicinal maintenance
anti-TB drugs, which is required for
Clinical and cost-effectiveness of the National TB
Program (NTP).
8.2 Objectives
� Identify systematic approach to medicine components
TB program.
� To strengthen the interaction PNP leaders and managers on management
Medicines software.
� To form practical skills of health managers,
aimed at the continuous presence of "correct" antidrugs (TAP), and their rational use.
8.3 Description of the organization of work on drug management software
One of the main tasks of medication management software (Ulo) within
National Tuberculosis Control Programme is a continuous supply
whole list of high-quality anti-TB drugs of first-line:
Rifampicin (R), Isoniazid (H), Ethambutol (E), pyrazinamide (Z) and Streptomycin (S).
Especially drug for SPE due to the basic principle of
antituberculosis therapy, which is based on simultaneously and continuously
application of several anti-TB drugs for the treatment of patients
Tuberculosis is not less than six months.
To perform this task must be optimal
operation cycle of drug supply (circuit number 1). Cycle
Drug Supply (TSLO) is based on four main functions:
• Selecting appropriate drugs
• Purchase of selected drugs
• Distribution of drugs purchased
• The use of distributed agents
TSLO core is the management or organizational support,
which provides for the existence of certain structures, human and
financial resources, as well as management information system of the medicinal
software. Organizational support is an integral part of each
element of the cycle of drug provision.
An important role is played by an information system that is designed to
timely exchange of information among all levels and levels of the system
drug supply. Thus, close cooperation between
90
PNP leaders and Ulo in addressing issues such as coordination of procurement
distribution, management, quality assurance of drugs
staff training and effective use of available resources (see
Appendix № 1 "Checklist of activities to manage drug
providing TAP managers PNP.
For the proper functioning of the cycle of drug provision is needed
legal framework and political support.
MEDICINAL MAINTENANCE CYCLE
CHOICE
Organizational Buying
support
DISTRIBUTION
USE
Legal framework and political support
Scheme 1
8.3.1 Choice of drugs - a process of establishing a limited list of
anti-TB drugs needed for procurement based on current
clinical guidelines and following the principles of good practice selection
drugs:
� conformity with established standards of treatment PNP
� Review of the nature of local resistance
� Objective information about drugs
� An analysis of the availability, quality and cost of drugs on the market
� The emphasis on a combination of drugs and blister packs
� selected drugs approved by experts in quality
The procedure for selection of drugs includes specifications and
define the list of drugs that will be distributed to medical
institutions of different levels of the program.
The specification for each product should include:
� description of the drug, the name of a pharmaceutical product or
name on the international nomenclature generics
� name of the drug taken within the country, if any
� Pharmaceutical form (eg tablets, ampoules for injection)
� dosage, for example, rifampicin 150 mg + isoniazid 75 mg
� Study leave, the number of units in the package
To effectively perform this function cycle management of medicinal
need to synchronize the instrument of choice products, ie, TAP,
specified in the standard chemotherapy SPE should be included in the
National list of essential drugs, and are registered in the country.
91
The latest achievements of pharmacology can successfully combine
TB drugs: in one pill can combine two, three, or
Four drugs with adequate doses, which provides
convenience of treatment and prevent monotherapy, thereby reducing the risk
development of drug resistance of Mycobacterium tuberculosis (MBT).
Use of combined fixed-dose (FDC)
represents an important means to improve the quality of health care
tuberculosis.
Advantages of using FDC:
1. Reducing the risk of misuse, as compared with
monocomponent preparations, and, accordingly, the risk of drug
stability of the ILO monotherapy
2. Compliance with the medical staff standard treatment regimens
3. Simplifying the procedures for taking the drugs for patients, facilitating compliance
regime and reduce the likelihood of inadvertent errors in drug therapy
4. Simplification of treatment with minimal probability of error in the appointment
drugs
5. Improved management of drugs: simplified
order, delivery and distribution of drugs at various levels of the program,
because there are fewer names of preparations with different terms
date.
8.3.2 Procurement of medicines - a multi-step cyclical process that
focused on achieving a reliable and regular income
TB drugs in adequate quantities of high quality and
affordable price.
Stages of the procurement cycle:
� An analysis of selected procurement of drugs
� assessment of drug demand
� The harmonization of drug needs and available funding
� selection method for the procurement of drugs
� Search and selection of suppliers
� Organisation Tender
� The definition of contractual terms for the purchase of drugs
� Monitoring the status of an order to supply drugs
� Receiving and checking incoming products
� payment in accordance with the contract
� The distribution of medicines
� Collecting information on the consumption of drugs from the system of drug
ensure
Thus, the procurement process involves various activities
require a very long time, and, often, the duration of the full cycle
procurement can achieve, and more.
However, even in cases where the procurement cycle lasts more than a year, there is a simple
mechanism to ensure a constant supply of drugs, it
92
simultaneous conduct of several cycles of procurement, overlapping.
Drugs are purchased for one year plus a reserve (buffer) stock, but then not
waiting for the delivery of drugs, start a new cycle of procurement.
Managers PNP TB control involved in the initial stages
procurement, to quantify drug requirements in each of
drugs, but they should also be aware of other activities associated with
procurement by providing the necessary information to experts on procurement.
Procurement of TB drugs is carried out in accordance with the law
"On public procurements" RK on July 21, 2007 № 303. Legislation
Republic of Kazakhstan on public procurement based on principles: (Article
3. The principles of legal regulation of public procurement).
1. optimal and effective spending of the money used for
State zakupokv;
2. provide potential suppliers equal opportunity to participate
in the procedure of public procurement, except
stipulated by the Law
3. fair competition among potential suppliers
4. publicity and transparency of government procurement
Must strictly follow the orders of the Committee Pharmacy MH RK № 26 dated February 17
2004 "On approval of instruction on the definition of medicines
be tempered with a prescription and without a prescription, according to which drugs
for TB treatment should be dispensed only by prescription. If
prescription of these drugs should discuss each case.
8.4 Methods for determination of drug needs
Evaluation of drug needs is a stage of the procurement cycle. Credible and
objective determination of drug needs is one of the factors
affect the principle of continuity of drug supply
anti-TB drugs.
To estimate the drug needs to TAP is recommended to use two
main methods:
1. Method "on the number of reported cases"
2. Method "on the previous consumption"
Method "on the number of reported cases is based on the forecast level
morbidity that requires accurate data on registered cases and
Regimens used to predict drug requirements. This
the most complex and time-consuming method, but at the same time it is the most persuasive approach
to justify budget requests for the purchase of drugs.
Method "on the previous consumption is based on accurate and complete data on
consumption of drugs from the system with a relatively uninterrupted flow of
preparations at its full supply of essential medicines list. For This method also needs accurate knowledge
of periods of absence Medication
medicinal stock and expected changes in consumption (demand) and the use
drugs.
In the case of long periods of absence of TAP on medicinal stock, this method
not allow to reliably determine the level of previous consumption. This method does not
reflects the rationality of the use of anti-TB drugs.
Table 15 - Comparison of methods for calculating drug needs
Method of Data Restrictions
In previous
consumption
Accurate and complete data on
previous consumption.
Data periods
lack of drugs in
system.
Long periods of absence
drugs in the system.
Does not reflect the rationality
use
Number
registered
GOVERNMENTAL cases
Previous and
Projected
statistics
number of tuberculosis cases.
Established standard
treatment.
Lack or inaccuracy
statistics.
Forecast the number of cases
TB - the value
changeable.
Standards of care may not
respected.
8.4.1 Method based on the number of registered cases of tuberculosis
Calculation of drug needs using the method of "the number
reported cases "means the evaluation of the expected number of TB cases
for each category of treatment in the coming year followed by a multiplication
the projected number of TB cases by the number of monocomponent or
Combined pills required for each category of treatment.
Number of doses expected number of total number of
to cure a case of X TB cases each = desired
TB drug category
Below is a stepping algorithm of actions needed to assess
drug needs using the method "the number of registered
cases "of TB.
Table 16 - The list of standard steps for evaluation of drug requirements
method "on the number of reported cases of" Tuberculosis
№ Name step
1 Make a list of TAP, a quantitative need for requiring
identify with an indication of the specifications for each drug
2 Determine the standard treatment
94
3 Collect data on the number of registered cases of tuberculosis per
previous period
4 Determine the expected number of TB cases in each category
5
To calculate drug needs of each drug
necessary to treat one patient in a certain mode of
categories I, II, III
6 Calculate the total number of basic units for the treatment of all patients
tuberculosis for all treatments
7 Consider the number of TAP on the medicinal stock and the need for
reserve
8 consider the possibility of "loss" of drugs through injury or other
causes
9 To assess the value of each drug and the total cost of purchased TAP
10 Compare the total cost of TAP with a dedicated budget for the purchase of
drugs
Step 1. Make a list of TAP, a quantitative need for requiring
identify with an indication of the specifications for each drug:
- Description of the drug, the name of the pharmaceutical product or
name on the international nomenclature generics
- Title taken inside the country if there is
- Dosage form (eg tablets, ampoules for injection)
- Dosage, for example rifampicin 150 mg + isoniazid 75 mg
- Study leave, the number of units in the package
- The projected purchase price for the basic unit or for packaging.
Step 2. Determine the standard treatment
The standard treatment - a treatment regimen, indicating the list of drugs, their daily
dosages and the number of doses needed to cure one case of tuberculosis
I, II and III categories of treatment.
Table 17 - Standard chemotherapy for tuberculosis patients
used in the calculation of drug needs
Diagnostic
category
Intensive phase Supportive
phase
I 2-4 RHZE (S) Streptomycin
used within 2 months
4 (RH) 3
II 3-5 RHZES Streptomycin
used within 2 months
5 (RHE) 3
III 2RHZE 4 (RH) 3
In calculating drug needs should be considered maximum
timing of therapy in the intensive phase of treatment.
95
Table 18 - FDC scheme dosage for adults with a light weight ranges
patients
Weight
range
(Kg)
Intensive phase Maintenance phase
2-5 months depending on
efficiency and the categories of treatment
4-5 months depending on the category
treatment
Every day, every day three times a
week
Every day, three times a
week
Daily
RHZE
150mg +75 mg +
400mg +275 mg
RHZ
150mg +75 mg
400 mg
RHZ
150mg +150 mg
500 mg
RH
150mg +75 mg
RH
150mg +150 mg
EH
400mg +150 mg
30-37 2 2 2 2 2 1.5
38-54 3 3 3 3 3 2
55-70 4 4 4 4 4 3
71 and more than 5 5 5 5 5 3
Step 3. Collect data on the number of registered cases of tuberculosis per
previous period
Data collection provides a retrospective analysis of recording and reporting forms to
determine the total number of reported cases of tuberculosis each
category of treatment. It is necessary to take into account the data at least three
statistically representative year. Under statistically representative
means periods of time (years), when the statistics were as
reliable.
Step 4. Determine the expected number of TB cases in each category.
To determine the expected number of TB cases in each category of treatment
can be considered as the rate of growth, and average statistical data in
availability of reliable databases on the number of reported cases during
years.
In the case of waiting to increase the identification of new cases of tuberculosis caused
deterioration of the epidemiological situation, or program activities may
We adjust the data.
When forecasting the expected number of cases of tuberculosis must be considered
additional factors affecting this value:
- Population covered by the health system;
- Migration of the population;
- Amnesty.
Table 19 - Example of calculating the expected number of TB cases in each category
treatment with the use of average data
96
Year
Category
2005 2006 2007
Avg.
Statistical.
2008
I 1030sl. 989sl. 807sl. 942sl.
II 497sl. 347sl. 342sl. 396sl.
III 176sl. 214sl. 238sl. 210sl.
Step 5. To calculate drug needs of each drug
necessary to treat one patient in a certain mode by categories
I, II, III.
Necessary to calculate the number of basic units for the treatment of one case
TB in each category c, given that all patients are in a weighted
range of 55-70 kg.
Table 20 - Example of calculation of drug needs for one patient on
each category of treatment.
Medica
cops
Category
treatment calculation
Common
number
basic units
RHZE
150mg +75 mg +
400mg +275
4 tab. X (30 days x 4 months.) = 480 Table.
For the intensive phase (daily). 480 tablets
RH
150mg +150 mg
I
Category 4 tab. X 54 days = 216 Table. For
maintenance phase (three times
week).
216 tablets
RHZE
150mg +75 mg +
400mg +275
4 tab. X (30 days x 5 months.) = 600 Table.
For the intensive phase (daily). 600 tablets
S 1gr.
Injections
1 gram injection x (30 days x 2 months)
= 60 vials for the intensive phase. 60 vials
RH
150mg +150 mg
4 tab. X 66 days = 264 ** Table. For
maintenance phase (three times
week).
264 tablets
E400mg
II
Category
Table 6. X 66 days = 396 Table. For
maintenance phase (three times
week).
396 tablets
RHZE
150mg +75 mg +
400mg +275
4 tab. X (30 days x 2 months) = 240 Table.
For the intensive phase (daily). 240 tablets
RH
150mg +150 mg
III
Category 4 tab. X 54 days = 216 Table. For
maintenance phase (three times
week).
216 tablets
Note:
97
* For I category in 4 months maintenance phase contains 18 weeks of treatment to 3 times a week
(18 x 3 = 54 days).
** For Category II in 5 months maintenance phase provides 22 weeks of treatment to 3 times a week
(22 x 3 = 66 days).
Step 6. Calculate the total number of basic units of the drug for the treatment
all TB patients in all treatment regimens.
Number of basic units of the drug for the treatment of one case of tuberculosis
be multiplied by the total number of expected cases of tuberculosis each
category of treatment. The action is carried out separately for I, II and III categories.
Table 21 - Example of calculation of drug needs to treat all patients
tuberculosis in all modes of treatment
Category I Category II Category III
Total
need
a quarter
Quantity
units
Quantity
units
Num.
units
He named.
Drug \
dose
Cases
Base units. at
1 case
(Q1)
Cases
Base units. at
1 case
(Q2)
Cases
Basic. units.
1 case
(Q3)
Q4 =
(Q1 + Q2 + Q3)
RHZE
150mg +75 mg
+
400mg +275
942 480 452
160 396 600 237 600 210 240 50 400 740 160
RH
150mg +150 m
r
942 216 2034 72 396 264 1045 44 210 216 4536 0 353 376
S 1gr.
Injections 942 - - 396 60 2376 0 210 - - 23 760
E400mg 942 - - 396 396 156 816 210 - - 156 816
Step 7. Take into account the necessary amount of TAP on medicinal stock and
the need for a reserve.
Prior to the evaluation of drug needs to be known by the time "
between placing orders and receiving drugs for each level of the system.
This time interval is referred to as "the average waiting time of the product."
If this interval does not exceed 6 months in the procurement plan should
address the needs of the medications for 1 year plus the required reserve or
buffer stock. If this period is more than 6 months, in the purchase order
should take into account stock for a period of more than a year.
The buffer stock is required in cases of sudden increase in diagnosed cases
tuberculosis, delays in receipt of drugs because of the failed bid
or distribution problems and loss of drugs due to damage or theft.
98
Thus, it is important to have a reserve stock at all levels of the system.
Recommended amounts of reserve at the district level - for 3 months on
regional level - a 3-month and at the central level - 6 months if
four-tier system of distribution of drugs.
It is important to note that the complete filling of all levels of reserve stock
conducted once, since subsequent requests for the purchase of drugs should
take into account the available balance (projected) on the day the preparations for
new application, and, as a rule, it should not be below the recommended level
reserve.
Table 22 - Example of formation of the application for anti-TB drugs
Quarterly
need
Reserve
margin for
quarter
Preparations in
available *
Only
ordered
Name of drugs
drug / dose Q4 Q5 (= Q4) Q6 TQ = (Q4 + Q5) Q6
RHZE
150mg +75 mg +
400mg +275
740 160 740 160 500 000 980 320
RH
150mg +150 mg 353 376 353 376 100 000 606 752
S 1gr.
Injection 23 760 23 760 10 000 37 520
E400mg 156 816 156 816 20 000 293 632
* Projected balance at the date of receipt of drugs on the new application!
Step 8. Consider the possibility of "loss" of drugs through injury or other
causes
To address the possible "loss" drugs, you can use the experience of previous
procurement and distribution of TAP. If the "loss" are significant, they need
correction in a certain percentage in the evaluation of drug requirements.
Step 9. To assess the value of each drug and the total cost of procured
TAP
A) Convert the number of required core units in the number of packages
B) Multiply the number of required packages of the drug on the cost of one pack
+-=(
Total Number of Number of major
required units of the drug product ÷ = ordered
in fundamental units of packed packages
Quantity Value Total
required X = cost of one
packaging packaging product
Estimated
drug
potrenost
Drugs
in stock
Being ordered
number
drug
Reserve
reserve
99
Following options are available to assess the value of procured products.
First choice: raise the price lists of products on
pharmaceutical market from local and international commercial suppliers,
also explore the quotations in the procurement of drugs through the international
non-commercial arrangements, such as the Global Drug Facility * (SFR / GDF).
The second option: to evaluate the cost of subsequent purchases through the adjustment of prices
last held the purchase, considering such factors as inflation, devaluation and
etc.
* SFF / GDF - one of the sources of acquisition of TAP at moderate prices. Created by
initiative program "Stop TB". GLF / GDF - International Service
for TAP.
Step 10. Compare the total cost of TAP with a dedicated budget for the purchase of
drugs
Each patient with tuberculosis should start treatment without delay and complete
treatment without interruption. If the budget does not cover the costs necessary
the purchase, the amount of drugs purchased must be synchronized with
number of patients to be taken for treatment, since the whole list
drugs must be continuously available.
Health managers should use all available opportunities and
resources to guarantee uninterrupted drug supply and
prevent breakdowns at all levels of GMP.
8.4.2 Method based on previous consumption
As an additional method for determining the drug needs in
availability of reliable data on previous consumption, the absence
drugs in the system, as well as on the number of patients who do not
received chemotherapy due to lack of drugs, the method "on
prior to consumption.
It should be borne in mind that the data on previous consumption can not
reflect the process of rational prescribing and use of medicines.
Below is a list of basic steps for determining drug
requirements for TB drugs using the method
based on data on consumption:
1. Make a list of TAP, a quantitative need which requires
determine
2. Determine the time period for which data are collected and the analysis
consumption data. If you plan to buy / order the drugs for 12
months, it is necessary to review the data on consumption for 12 months
3. Submit data on consumption of each drug during the reporting period,
including the total number used during the test period, the number of
days in the absence of each drug in stock and the average waiting time for several
Last Procurement
100
4. Calculate the value of "average consumption of drugs" for a month - it
main parameter in the calculation formula, so it must be as accurate
5. Calculate the volume / buffer stock for each drug
6. Calculate the amount of drug in the next cycle purchase
7. Adjust the above calculations drug based on anticipated
changes in consumption
8. Adjust the calculations performed with allowance for possible losses of drugs in
during transportation and storage
9. Record number of drugs available in stock at the moment
10. Record number of drugs that have already been ordered but not yet arrived
11. Combine these decentralized calculations, ie calculations for individual
hospitals or storage of drugs
12. To assess the value of each drug and the total cost of procured
drugs
13. Compare the total cost to the budget and make necessary adjustments
Formula:
1. The average consumption of drugs per month, including the period of absence
this drug:
(Ca) = CT ÷ [RM - (DOS ÷ 30.4)]
2. Volume / buffer stocks:
(BS) = Ca × LT
3. Number of ordered products:
(QO) = Ca × (LT + PP) + SS - (S1 + SO)
Ca = Average consumption of drugs per month, based on the period of absence
this drug
CT = Total consumption of the drug over this period in the basic units
For example, in tablets
DOS = Number of days when the drug was absent in stock
LT = average waiting time of products in months
PP = length of the period of purchase (for how long will purchase drugs
- In months)
QO = Number of ordered products in the base unit before adjustment
loss or programmatic changes
RM = Length of the analyzed period in months (number of months
data are analyzed to draw up predictive evaluation)
SO = Quantity ordered but not yet received drugs in the basic units
S1 = The number of drugs actually available in stock in the basic units
SS = Number of drug required for safety / buffer stock
30.4 = Average number of days in month
101
Example of calculating the number of ordered product using the method
"On the previous consumption"
1. Calculation of average monthly consumption of drugs
Formula: (SA) = CT ÷ [RM - (DOS ÷ 30.4)]
Conditions:
a) CT - total consumption of the drug for the analyzed period 150 000
Rifampicin 150 mg tablets.
b) RM - the duration of the test period - 6 months
c) DOS - 60 days during the absence of drugs in the system of drug supply
(Ca) = 150 000 ÷ [6 - (60 ÷ 30.4)] = 37 500 tablets of rifampicin 150 mg of
average consumption per month of the drug.
2. Calculation of reserve
Formula: (BS) = Ca × LT
Conditions:
a) Ca - the average monthly consumption of the drug Rifampicin 150 mg of 37 500
tablets
b) LT - the average waiting time of products - 3 months
BS = 37 500 × 3 = 112 500 tablets of rifampicin 150 mg of
cushion
3. Calculation of the ordered quantity of the drug
Formula: (QO) = Ca × (LT + PP) + SS - (S1 + SO)
Conditions:
a) Ca - the average monthly consumption of the drug Rifampicin 150 mg given
period of absence of drugs is 37 500 tablets.
b) LT - the average waiting time of products - 3 months.
c) PP - a term which will be purchased drugs - 6 months
d) SS - the amount of the drug to form a reserve - 112 500 tablets
Rifampicin 150 mg
e) S1 - the actual amount of the drug in stock - 90 000 tablets of Rifampin
150 mg.
f) SO-quantity ordered earlier rifampicin 150 mg, but not yet received
20 000 tablets of rifampicin 150 mg.
102
(QO) = 37 500 × (3 + 6) + 112 500 - (90 000 + 20 000) = 340 000 tablets of Rifampin
150 mg need to order to cover the 6 months requirement and the formation of 3
monthly reserve, taking into account that the waiting time is 3 months.
8.5 Managing the evaluation of drug demand
Managing the assessment of drug requirements are divided into two phases
• Preparatory
• Calculation of the needs of drugs
8.5.1 Preparatory Phase - important points
An important first step in identifying large-scale drug
needs a preparatory process:
� The definition of responsible person or entity that will manage
the process, define roles and responsibilities;
� The formation of a working group for coordination between agencies and
departments involved in the process of determining the drug needs;
� The wording of the objectives and define the scope of the calculation of drug
needs
� selection method for calculating drug needs;
� Define list of drugs
� Score required time
Large-scale identification of essential drugs is a timeexpensive process. In this connection should be set a realistic time
frame for each step in determining drug demand. Timeframe in
mainly depend on the number of levels of drug supply and
availability. In a multilevel system with incomplete data process
estimates of drug requirements may take several months.
The influence of average waiting time of product
Number of purchased product should be sufficient so long, as long
the next cycle of procurement. The process of procurement can take place within a few
months: sourcing, tendering, receiving and checking incoming
drugs etc.
For example: If the average waiting time of products (LT) is 3 months,
average monthly consumption (Ca) is 37 500 tablets of rifampicin 150 mg, then
minimum buffer stock (SS), should be 112 500 tablets of Rifampin 150
mg ("Method for the previous consumption"). Thus, for constant
maintain a minimum stock level for the supply of TAP application must be submitted
in stock 225 000 tablets of rifampicin 150 mg, provided that the term
implementation of a new order for 3 months.
103
Model of inventory control
Time in Months
Stk.
Reserve
Reserve
Slave
ochy
Volume
LT
1369
(BS) = Ca × LT
Delivery
Consumption
Scheme № 2
Conducting training for managers of the district and regional level on how
determination of drug needs
8.5.2 Phase calculation needs drugs - important points
� The collection of data depending on the chosen method of calculating drug
requirements (number of patients, therapies, etc.)
� Maintain feedback from regional and district managers,
deploying applications to the need for TAP
� Conduct calculate drug needs
� Score total purchase price
� adjustment and harmonization of the final number of drugs
� Conduct training for managers of the district and regional level
Survey management and use of drug stores
drugs
� To assess the process of determining the drug needs and identify
room for improvement
8.5.3 Distribution of drugs aimed at ensuring uninterrupted
preparations of all agencies, where we treat patients with tuberculosis,
required quantity and the calculated time. The process of distribution of drugs
includes:
� clearance of drugs
� Receive and inspect incoming products
� Inventory control warehouse
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� Storage of drugs in accordance with the requirements
� holiday preparations for medical
� deliver drugs to health facilities
� Provide information on the consumption of drugs from the system
pharmacological support to the Department purchasing agents
Under continuous or uninterrupted provision of medicines means
availability of the full range of TAP 365 days a year on drug storage and
medical offices, establishments, where we treat patients with tuberculosis.
Interruptions in drug supply and cause treatment failure
the emergence of resistant forms of tuberculosis.
After selecting the "right" drugs in the appropriate dosages and
combinations, to conduct adequate chemotherapy for all weight
ranges in accordance with established standards of treatment, the period
procurement cycle. In turn, the cycle begins with the distribution of drugs
moment of sending the products manufacturer or supplier and ends
report on the consumption of drugs, which comes to the Department of Procurement.
8.5.4 The main objectives of the system of distribution of drugs:
1. Maintain a constant and uniform provision of drugs given
reserve
2. Store medications under proper conditions
3. To minimize the loss of drugs due to spoilage and expiry
Life
4. Use affordable transport as efficiently as possible
5. Avoid theft and fraud
6. Provide information to predict drug
needs
Availability of and compliance with inventory control procedures at all levels
program is important to prevent breaks in the system of medicinal
provision and availability of reliable data to assess drug
requirements in a subsequent purchase, and to ensure the quality of drugs in
during storage and distribution.
For the purposes of monitoring procurement managers can use the formulas
Minimum (Smin) and maximum (Smax) inventory levels, through which
calculated, when to place an order, and for a number of drugs (Qo)
He should be drafted.
8.5.5 Mechanism of leave and receive TAP
Person VET (Head pharmacy charge nurse),
receiving TAP, draws the accounting of attorney (Form № M-2a
approved by order of the Ministry of Finance of the Republic of Kazakhstan № 548 dated December 1,
1998) on
obtaining drugs. Exception is himizatory PHC.
105
In VET, which issued the prescription surface (at regional level - 4, at
district level -3) with obligatory indication of the number invoice, name of recipient
attorney, as well as the name, dosage, units, number
certificate, series, shelf life, the number allotted to the drug, the price and amount
for every name of the drug. Responsible for providing the price of one
unit of drugs is an accountant VET. In VET, issuing a TAC
there are 2 bills (one in accounting, the other - in the pharmacy or department).
The remaining 2 bills are passed, together with drugs (1 - to the accounting department, the other in the office or pharmacy VET, which will continue the treatment the patient).
When sending a TAP from the pharmacy VET (regions, districts) in the NKL cabinet (PTI PHC) for
treatment on an outpatient phase of treatment delivery is carried out on preparations
Based on the requirements drawn himizatorom. The requirement is filled according
Card TB 01 and TB 01 - Category IV. Responsible person issuing the TAP PHC
fills three bills, one of which is transmitted together with TAP, one remains in
accounts of issuing TAP, one - at the head of pharmacy warehouse.
All cases of gain and loss of anti-TB drugs must enter
in TB 12 - log anti-TB drugs (see Guide
recording and reporting forms) the day of admission (leave). Parish registers TAP
on the basis of invoices, expense on the basis - invoices and claims. At the level
PHC - on the basis of marks in sheet maps NKL TB 01 and TB 01 - Category IV.
8.5.6 The formula for determining the minimum and maximum level of stocks and
number of ordered products
� Smin = (LT × Ca) + SS
� Smax = Smin + (Pp × Ca)
� The number of ordered products (Qo) = Smax - (So + S1)
(See Method "on the previous consumption" and "Managing the assessment
drug needs).
Prior to the distribution of drugs from the host storage they should be
inspected for quantity and quality. This includes visual
random inspection for labeling of drugs (language, drug
form, dosage, storage period or shelf life), the number of each received
medicine and their compliance with the contract specification. In addition, should
carried out the procedure of selective removal of samples for the corresponding
laboratory testing - identification testing for
active ingredient, as well as test for dissolution.
After the party was set quality control and testing,
begins distribution of drugs in hospitals. To ensure
timely supply of TAP, is necessary to receive from medical
agencies information on existing holdings and applications for drugs
based on the calculation of the registered (or expected) number of patients
tuberculosis.
106
Important points to appropriate rules governing the storage and issue of TAP:
� Proper maintenance of approved accounting and reporting documents for
receipt and dispensing of drugs
� Rotation medicines stockpile shelf life (storage and
holiday preparations according to the rule FEFO, ie preparations with an earlier expiration
expiration date are released in the first place and stored in the front of
repository)
� Storing drugs in a dry and well ventilated area out of direct
exposure to sunlight and in accordance with the approved temperature
regime
� systematic review of drug stockpiles for each item and
maintenance reserve (see Diagram № 2)
The current system of distribution of TAP in Kazakhstan is designated as «PUSH»
system: at the national and provincial levels is determined by the list and the number
drugs, which are distributed to lower levels of drug
software. In this system managers to provide information on
consumption and drug residues to the source of supply of drugs for
procurement planning and distribution of drugs.
8.5.7 Rational use of drugs implies:
� The correct diagnosis of tuberculosis and determination of categories of treatment
� Appointment of standard chemotherapy
� Adequate doses of chemotherapeutic drugs in accordance with the weight of the patient
� direct control over the patient while taking drugs
� patients' adherence to assigned treatment
Based on the foregoing, the process of using drugs can be
presented in the form below schema:
The process of using drugs
Scheme № 3
Diagnosis
Control
Commitment Appointments
patient
Issue / NKL
107
Rational use of anti-TB drugs is one of the key
components of NPP. Rational use of drugs contributes
quality treatment from a clinical point of view and profitability programs
economic aspect.
There are a number of factors at the basis of irrational use of drugs is
infrastructure and management gaps in the health system, cultural
and the social fabric of society, lack of knowledge and independent information,
inefficient work with the patient, inadequate advertising, unlimited access to
drugs, and underestimation of the process of NKL.
NKL is required to ensure patient adherence to treatment. NKL helps
motivate the patient to complete treatment and to anticipate problems with
adherence among TB patients, as well as prevent the emergence of
resistant forms of tuberculosis.
NKL by WHO - means that a person who controls a drug watch
the process of swallowing pills, displaying sympathy and support
needs of the patient (see Appendix № 1).
8.5.7.1 The tasks of medical personnel conducting NKL TB patients:
� Do not make the patient wait
� Provide "right products" in accordance with the established regime
supplementation
� Making a mark in the map of 01 TB each adopted a dose
� To know the possible side effects of drugs and when they appear to direct
patient to the doctor
� Maintain and encourage the patient to continue taking the drugs
� Respond quickly if you skip taking the drugs the patient
The organization, in practice, NKL and continuing commitment to treatment is a complex
task, particularly during outpatient treatment. To successfully address this
problem not only efforts by public health, should be involved in
This process of local government and the public.
One of the causes of irrational use of TAP is their availability in
private retail pharmaceutical market. TAP should be used only
qualified personnel TB agencies
Health.
Identify and examine the causes of irrational use of TAP, followed by
elimination is a key success factor for GMP.
8.6 Monitoring
Monitoring is an integral part of the routine management of medicines
software. Systematic monitoring of the indicator on the basis of in accordance with
108
tasks and ongoing activities necessary for successful
functioning of the system of drug provision PNP at all levels.
The main task of monitoring - to determine the degree of correspondence between the implementation
programs and set standards that can identify operational
problems that arise in the process of health workers
places and their subsequent correction.
Managers GMP should be involved in the monitoring system of drug
supply, including the selection, procurement, distribution, use and maintenance
quality products.
There are a number of key and additional indicators for monitoring system
pharmacological support TAP. Data on the key (CI) indicators should
measured regularly to ensure GMP continuous supply of high quality
drugs, as well as to assess the economic efficiency of the procurement process.
Additional (CI) indicators can be used for advanced
Monitoring control system ensuring medicines TAP.
Here are some key indicators and additional monitoring
LO.
8.6.1 Key Indicators
K-1 Average duration (in percentage) lack of
list of TAP in TB facilities.
K-2 Percentage of new cases of pulmonary tuberculosis with smear-positive cases,
receiving a proper treatment in accordance with the clinical
leadership.
K-3 Percentage TAP received during the last three deliveries, which were
Certificate Party
K-4 Percentage of median international price paid for a list of TAP in
the last purchase
8.6.2 Additional indicators
D-1 Percent of pharmaceutical products included in the PNP National
list of essential drugs
D-2 Percentage of samples of TAP, which are not tested for quality control
the total number of samples tested during the past year
D-3 Percent of TB facilities visited, where there was a
the presence of recent official publication of clinical guidelines on tuberculosis
D-4 Percentage of patients who reported receiving TAP under the control of
health workers.
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8.6.3 Description of the indicators included in the "Compendium of indicators for
monitoring and evaluation of N "World Health Organization, 2004.
8.6.3.1 Availability of quality assurance program (PPW) in drug
Administrative
Determination
Availability
Determination
The presence of PPW in drug provision for monitoring the safety
used drugs residents. Answer "Yes" or "No".
What to measure
This indicator measures the PPW, which includes agencies or committees
for the registration of drugs, the choice of quality products and suppliers
certification of products, development of contract specifications and
performance of external inspection and laboratory analysis of drugs received, and
there are procedures for feedback to the notice of the problems encountered in
the use of the drug.
How to measure
This indicator is measured through a review of documents of the Ministry
Health (MoH), describing the PPW, as these documents are not always
are the managers of TB programs, PPW may include
a single agency or a few, but should hold all of the above
activities.
The health system can use more detailed indicators for
identifying the specific weaknesses of the PPW. But generalizing indicator should
expressed as "Yes", unless the list of all the components PPW:
- The presence of the regulatory framework right to regulate drug supply
- Availability of a system of registration of drugs
- Availability Inspection Service
- Availability of laboratory testing
Data source
- Documents MZ
- Documents National Formulary Committee
Frequency and designation
This indicator should be measured and reported on an annual basis.
Strengths and limitations
This indicator is not specific for the TB program, he
characterized by the presence of a whole PPW, which is important for the entire health system.
In many countries there PPW. This indicator - this is an additional check
for TAP, domestically produced or procured from international suppliers.
The indicator is not acceptable for external monitoring, especially on a regular basis.
Documents may describe a good MH PPW, but in practice, it operates
110
partially. This indicator measures the availability of the PPW, but does not characterize it
functionality.
8.6.3.2 Availability of reserve at the central, regional or district
storage levels
Determination
The presence of reserve (buffer) stock TAP to ensure regular supplies
treatment centers. Recommended level of reserve is 6 months
central level and 3 months at the regional and district levels. Answer "Yes" or
"No".
What to measure
This indicator measures whether the National Programme for Control
Tuberculosis necessary resources and institutional capacity to avoid
interruptions in drug provision through the availability of additional
quantities of drugs, ie reserve. The buffer stock is required
element of the system of drug provision aimed at preventing
interruptions in the supply of medical centers that may arise as a result
errors in the evaluation of drug requirements, as well as a number of other reasons.
How to measure
This indicator is formed after a review of documentation on the calculation of drug
needs of the National Programme for Control of Tuberculosis. Review
relevant documentation to determine whether the reserve stock accounted
in assessing drug needs, commissioned and adopted at various levels
system. For example, if the program conducts supplying drugs once a year for 12
months, then in addition to the purchase must be included and a stockpile of 6
months. At the district level when ordering drugs for 3 months should be included
and a reserve order for 3 months. The presence of inadequate reserve of
any of the TAP denotes the result of "No".
Data source
- Documentation for the calculation of drug needs
- Documentation for Procurement
Frequency and designation
This indicator should be measured annually at the central level and twice
year in the regional and district stores
Strengths and limitations
This indicator does not measure all the problems in the chain of drug supply,
causing interruptions in the availability of drugs at health facilities.
However, this indicator measures the capacity of the program and the availability of resources for
prevent interruptions in delivery times from TAP at all levels of storage.
8.6.3.3 The accuracy of accounting and reporting documentation repositories for TAP
111
Determination
Percentage of compliance (records) recording and reporting documentation to the actual
number of TAP in drug stores
Number of records (documentation), corresponding to the actual number of
× 100
The total number of audited accounts
What to measure
Proper management of drug stores is important for continuous
of TAP treatment facilities. One of the important activities is
exact calculation of drugs taken and distributed from the warehouse. When
The actual data on the number of drugs vary with the data contained in
documentation, this leads to errors in the preparation of the application products.
How to measure
The number of each TAP should be counted in the drug stores and
warehouses of medical institutions. This is the actual number is compared with
quantity of the drug specified in the registration and reporting documents, or
individual storage cards. If this amount of drug or more than
less than the estimated (actual), it is denoted as the discrepancy in
record. The number of entries corresponding to the actual balance of drugs in
stock must be added up and divided by the total number tested
records. This number is multiplied by 100 per cent accuracy for the removal of records in
this repository.
Data source
- Warehouse documentation (card) for each drug
- These actual counts
Frequency and designation
This indicator should be determined twice a year for national,
regional and district warehouse (storage).
Strengths and limitations
This indicator allows managers to monitor the work of warehouse employees
premises and to identify weaknesses in the system of continuous drug supply
TAP. Frequency measurement of this indicator can be changed to once a year
in the case of a stable accuracy in the warehouse records.
8.6.3.4 The period of time the lack of TAP in drug stores (stores)
Determination
The average percentage of time the lack of TAP first-line drug stores
The total number of days in the absence of TAP delivered the first series
× 100
(365 × number of TAP)
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What to measure
This indicator measures one of the key moments of the program, such as
continuity in the drug provision. This is a basic principle, because all
TAP should be available for adequate patient treatment and prevention
emergence of resistant forms of tuberculosis. This indicator should be
used in conjunction with the indicator number 6 for the understanding of the actual presence of TAP
and existing management practices in the drug supply.
How to measure
Data should be collected as soon as possible with plenty of storage space
central, regional and district levels. This indicator is calculated
by determining the number of days in the absence of each drug during
past 12 months, based on accounting and reporting documentation repositories with their
followed by summation of total days of absence of the drug. Then
total number of days divided by 365, and multiplied by 100.
Data source
- Storage card for each drug (accounting and reporting documentation)
Frequency and designation
This indicator should be determined on a quarterly basis for all stores at all
levels.
Strengths and limitations
Measurement of this indicator should be a routine undertaking internal
monitoring. When this indicator is used during the external monitoring
possible inaccurate analysis because the data will be presented only with
areas visited by the evaluation team.
8.6.3.5 The period of time the lack of TAP in hospitals
Determination
The average percentage of time the lack of TAP first row in hospitals
The total number of days in the absence of TAP delivered the first series
× 100
(365 × number of TAP in the hospital)
What to measure
Availability and accessibility of medicines essential for the successful management
tuberculosis and uninterrupted supply of drugs and medical institutions
it is very important to cure patients and prevent the emergence of resistant
strains of tuberculosis. This indicator measures the component of the NPP such as
continuity in the drug provision. This is a basic principle, because all
TAP list should be available for adequate treatment and prevention
development of MDR-TB. This indicator should be used in conjunction with
indicator of the number 6 for the understanding of the actual existence of TAP and the available
management practices in the drug supply.
113
How to measure
Data should be collected as soon as possible with a larger number of medical institutions
central, regional and district levels. This indicator is calculated
by counting the number of days in the absence of each drug during
last 12 months, based on accounting and reporting documentation, followed by
summing the total number of days in the absence of the drug. Then total
number of days divided by 365 and multiplied by 100.
Data source
Recording and reporting documentation storage of medical institutions
Frequency and designation
This indicator should be determined on a quarterly basis to all hospitals
at all levels.
Strengths and limitations
Measurement of this indicator should be a routine undertaking internal
monitoring. When this indicator is used during external monitoring
possible inaccurate analysis because the data will be presented only with
areas visited by the evaluation team.
8.6.3.6 The basic structural unit, where TAP available
Determination
The proportion of basic structural units, where TAP are available on the day
inspection
Number of visits to the main structural units, where TAP in the presence of
× 100
The total number of visits to the main structural units
What to measure
Availability of drugs is essential for successful management of TB. This
indicator measures the functionality of systems procurement and inventory
management to ensure that drug treatment facilities in accordance with
needs of the patient. This indicator should be used in conjunction with
indicator of the number 4 and 5 for the understanding of the actual existence of TAP and the available
management practices in the drug supply.
How to measure
Data should be collected as soon as possible with a more fundamental
structural units of the TB program. This indicator
calculated based on the records of the presence of drugs in warehouses
on the day of his visit to the institution. The data obtained are compared with the list
drugs, which should be available. Drugs expired
not counted because they can not be used to treat patients.
Agencies (agencies) who did not have proper list of drugs
fixed. The number of institutions, where all the necessary list of TAP was the presence
114
on the day of inspection, summed. Then, this number is divided by the total number
institutions visited.
Data source
- Preparations warehouse facilities and warehouse records
Frequency and designation
This indicator should be determined on a quarterly basis for analysis at the National
level
Strengths and limitations
Data collection for this indicator may be a routine event
internal monitoring. However, when this indicator is used during
external monitoring is possible inaccurate analysis because the data will be
presented only with the institutions visited by the evaluation team.
8.6.3.7 Samples of TAP, not tested for quality control
Determination
Percentage of samples TAP, not tested for quality control in laboratories
quality control of the country.
The number of samples of TAP did not pass the test for quality control
× 100
The total number of samples of TAP tested in laboratories
Quality control of the country
What to measure
TAP should be purchased from reputable sources with a good reputation and should be
certification authorities of the receiving country for safety,
efficiency and quality. The system of drug supply should
provide appropriate storage conditions of drugs. This indicator measures
the proportion of tested PTP, which did not meet the criteria of the standard
quality specified by the receiving country. Ideally, all samples must go
tested successfully. Availability of samples of drugs not tested on
quality control, evidence of a weak manufacturing practices and gaps in
delivery system from the supplier, the bad system, storage and distribution
by the receiving country.
How to measure
The total number of samples of TAP did not pass quality control, is fixed and divided
the total number of samples TAP actually tested. This number is multiplied
100 to calculate the percentage of drugs that have not undergone tests to monitor
quality.
Data source
- Register of Quality Control Laboratories
- Reports MH
9. Tuberculosis and HIV
TB is a major opportunistic infection and leading cause of
death among HIV-infected persons. In Kazakhstan, he was diagnosed in
average of 45,8% of patients in symptomatic stages of HIV - infection and
36% in the structure of the causes of death among HIV-infected individuals (data RC
AIDS, 2003).. HIV infection contributes to the development of tuberculosis in recent
Mycobacterium tuberculosis-infected individuals and increases the risk of reactivation
latent TB infection. The spread of tuberculosis among HIVcontingent positive epidemiological situation worsens
tuberculosis among the general population. Events for the timely identification,
treatment and prevention of tuberculosis among HIV-infected persons are
essential component of national TB programs.
9.1. Detection of TB in HIV - infected persons
9.1.1 Detection of pulmonary tuberculosis
1. Radiography of the chest (children, adolescents, adults) - when
Establishment of HIV-positive status, if the previous X-ray
conducted over two weeks ago. Later X-ray chest
cells is carried out - 1 times per year.
2. Radiography of the chest of HIV - infected persons (children,
adolescents, adults) who applied for the place of registration for the first time in a given year,
regardless of the reasons treatment, if the previous X-ray
study was 1 year or more ago. Persons older than 14 years may
conducted fluorography.
3. The triple microscopic examination of sputum for
acid-fast bacilli (AFB) in the presence of any cough
duration. For negative results of smear
conducted radiography (fluorography) of the chest.
4. Screening for tuberculosis HIV - infected persons living in
contact with patients with pulmonary or extrapulmonary tuberculosis
regardless of the presence of bacteria in the patient - is organized
TB doctors territorial TB dispensaries (offices).
The complex diagnostic tests include X-ray organs
chest, if it was made 4 or more months ago (when
necessary - tomographic study, including through the median
plane), a common blood test. If you have contact with any coughing
duration conducted three times smear for AFB, and
with negative results - three-time sowing of sputum for the Office. At
the presence of cough and absence of sputum examined bronchial washings.
All other studies are indicated.
117
Detection algorithm of pulmonary tuberculosis in HIV-infected
E
Rentgenogrografiya bodies
Chest: (children,
adolescents, adults)
Persons older than 14 years may
conducted fluorography
In establishing the HIV - positive
status in the future - 1 times per year
When referring to a doctor for the first time in this
year, regardless of the reasons for treatment,
if the previous R-logical
study was 1 year and more
back
B-scopy sputum for AFB
(Thrice)
At negative triple
results of microscopy
sputum being
Chest x-ray
When referring to a doctor with suspicious
TB clinical symptoms
(Including cough of any duration)
Screening for tuberculosis
HIV-infected persons
living in contact with
patients with pulmonary or
extrapulmonary tuberculosis
regardless of
mycobacterium patient
The volume of research:
1. Radiography of the chest
(If it was made 4 or more months ago)
if necessary - tomographic
research, including through the median
plane
2. In the presence of cough of any duration triple smear for AFB, with
negative results of microscopy
sputum - a three-time culture conversion at the Office.
In the presence of cough and no sputum
study of bronchial washings.
3. Complete blood count.
5. Other studies - on the evidence.
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9.1.2 Identification of extrapulmonary tuberculosis
When taking on record, with the planned medical examination and treatment of complaints
HIV - infected persons held:
- A thorough collection and analysis of medical history, targeted the identification of complaints and
objective symptoms, suspicion of extrapulmonary tuberculosis:
headaches, visual disturbances, meningeal signs, symptoms of
cranial nerves, pain in joints, bones, spine, abdominal pain, in
the kidneys, changes in the urine, increased peripheral
lymph nodes, especially the softening of their contents and
formation of fistula;
- If necessary - the operational organization of consultations phthisiatrician,
neurologist, ophthalmologist, specialist for extrapulmonary tuberculosis:
ftizioosteologa, urology, gynecology;
- Carrying out the necessary complex radiation, instrumental and laboratory
investigations: ultrasound, computed and magnetic resonance imaging brain
brain, spine, joints, kidneys, abdominal, pelvic,
laparoscopy, likvorologicheskogo study of cyto-and histological,
tuberculosis microscopy and bacteriological research on tuberculosis
punctate, aspirates, biopsies.
9.1.3 Organization of detection of tuberculosis in HIV - infected persons
Identification of tuberculosis in HIV-infected persons organized physicians Centers
AIDS, or cabinets of infectious diseases (KIZ) in urban and regional
clinics in which these persons are registered, or doctors of PHC facilities,
behind which is enshrined care of HIV-infected individuals.
HIV-infected persons in the capture register informed experts
AIDS centers that, when the emergence of any symptoms they should contact the
territorial AIDS centers, or KIZy the place of registration, or medical institutions
PHC.
When planning visits to the doctor the place of registration of HIV-infected persons
purposefully interviewed a doctor about whether they have complaints, suspicious
against pulmonary and extrapulmonary tuberculosis.
If you have complaints, suspicious for TB, HIV people infected with AIDS from the Centers are sent to the territorial
TB dispensaries or (for privacy) - in
KIZy territorial polyclinics. Patients should be conducted
microscopic examination of sputum for AFB, chest X-ray
cells of other studies.
At detection of AFB in sputum, patients were sent to the TB
dispensaries. For negative results of sputum examination is conducted
X-ray of the chest. In the absence of changes on the radiograph
patients are sent to the therapist. In the presence of radiological changes in
Lung patient consults phthisiology. Future Tactics determined
119
nature of X-ray changes. When the need for
differential diagnosis of pneumonia - appointed antibiotics
broad-spectrum within 2 weeks in stationary or ambulatory
conditions in institutions OLS. You may not use antidrugs. In the absence of clinical and radiological improvement or torpid
During the process be repeated three times microscopic
sputum for AFB. Future Tactics is determined jointly
psychiatrists and specialist AIDS Centre.
Routine chest X-ray of HIV - infected persons (1
once a year) as being in the territorial polyclinics in the direction of physicians
Kiesow, or primary care physicians who are responsible for monitoring HIV-infected persons.
If HIV - infected patients observed in the center of AIDS, then for
X-rays, he goes straight to the TB dispensary
or, for privacy - in the KIZ territorial polyclinics
and physician referrals Kiza in X-ray room.
In the TB dispensaries and the Center for AIDS among doctors allocated
person responsible for contacts between the two services.
In the TB dispensaries city, district and regional levels,
National Centre for problems of tuberculosis (NTSPT) and territorial AIDS centers
creating a common database of patients with tuberculosis and HIV coinfection. Reconciliation of data between agencies and TB services
AIDS services by 1 time per month.
In TB institutions access to information about HIV-infected
individuals are only the principal doctors of these institutions and individuals, specially selected
for contact with AIDS services, with a subscription to them is taken
Nondisclosure.
9.1.4 Use of Mantoux test in HIV-infected
Given the limited capacity of HIV - infected organism to
the formation of delayed-type hypersensitivity reactions, Mantoux test is not
can be used in HIV - infected persons as a qualifying test for
further research on tuberculosis. Negative or equivocal
reaction to tuberculin in Mantoux test in HIV-infected persons, including children and
teenagers, not preclude not only the possibility of infection with Mycobacterium
tuberculosis, but the presence of active tuberculous process. For this reason,
Mantoux test is not used to detect infection with TB in HIV
- Infected children and adolescents. Annual production of Mantoux test HIV
- Infected children and adolescents is not carried out. With a view to early detection
TB all HIV - infected children and adolescents are routinely 1
once a year (according to the testimony - often) performed chest X-ray.
If necessary, appointed consultation phthisiatrician.
9.2 The course of tuberculosis in HIV - infected persons and the difficulties
differential diagnosis
120
The most common form of TB in HIV - infected persons, especially in
adults is pulmonary tuberculosis. In the early stages of HIV - infection,
superficial degree of immunodeficiency (number of CD-4 cells in the blood of more than 350 in 1 ml) it
typically occurs (as a secondary tuberculosis), with the formation of cavities in
light and bacteria.
In the later stages of HIV - infection, while reducing the number of CD-4 cells in the blood of 200
and less than 1 ml., pulmonary tuberculosis is often lower lobe localization
proceeds according to the type of primary or disseminated, accompanied by an increase
intrathoracic lymph nodes, lesions of serous membranes (TB
pleurisy, peritonitis, pericarditis), central nervous system, other organs and
systems. Despite the extensive destruction of lung cavity decay are not formed and
mycobacteria in sputum is not detected.
Table 23 - Characteristics of pulmonary tuberculosis in the early and late stages of HIV infection
The diagnostic features of advanced HIV - infection:
TB Early Late
The clinical picture often resembles
secondary tuberculosis
Often resembles
primary tuberculosis
Result microscopy
smear
Often the positive part of the negative
Changes in
Chest
cells
Often the presence of cavities
collapse
Often extensive
infiltrates without cavities
collapse
In recent years the number of tuberculosis cases with negative smear
Sputum in HIV - infected persons. No reliable criteria for laboratory
diagnosis of tuberculosis in patients with negative results
tuberculosis microscopy and culture examination of the sputum is not currently
exists.
Typical radiographic changes of tuberculosis in the lungs with the formation
cavities are found in other opportunistic infections:
pneumocystis carinii pneumonia, cytomegalovirus lung, pnevmomikozah.
If you can not exclude tuberculosis should start
antituberculous therapy.
Often in the background of HIV - infection, particularly with the expressed protein and
develop extrapulmonary forms of tuberculosis: Tuberculosis of the abdominal cavity
bones and joints, multiple lesions of peripheral lymph nodes.
HIV-infected children in the early stages of HIV infection without marked
immunity disorders tuberculosis occurs in the same way as children without HIV infection.
As the progression of immune deficiency developed disseminated disease
tuberculosis: miliary tuberculosis, tuberculous meningitis, generalized
lymphadenitis.
121
There are difficulties in the diagnosis of tuberculous meningitis in HIVinfected persons. Composition of cerebrospinal fluid in the development of
tuberculous meningitis in the background of HIV infection may remain normal. Thus,
noted that 40% of patients with tuberculous meningitis in the background of HIV infection in
composition of cerebrospinal fluid is recorded normal levels of protein in
15% - a normal level of glucose and 10% - normal cytosis (TB / HIV. A Clinical
Manual. WHO, 2004). If you can not exclude tuberculous meningitis in
HIV-infected patient should immediately begin
antituberculous therapy.
In some cases, especially in the later stages of HIV infection, TB in HIVinfected persons may occur as a generalized process, the type of acute
miliary sepsis. Clinical condition of patients with severe, there was a high
fever, chills, profuse sweats. Despite the serious health condition
radiologically miliary lesions in the lungs may be within 2 - 4 weeks not
identified. Reliably establish the diagnosis of tuberculosis in such cases
possible, often it is installed in such patients only
autopsy. Tactics physician in these cases should be next. First of all,
necessary, assuming the patient's sepsis non-tubercular etiology, a
broad spectrum antibiotics, using ingibitorzaschischennye
penicillins (amoxicillin-clavulanate), macrolides, cephalosporins, carbapenems
(Tienam). Antibiotics are recommended to enter in high doses intravenously. At
no effect of treatment within a few days, we should be suspicious
tuberculosis and immediately begin TB treatment. Diagnosis of tuberculosis
in such cases can be formulated as "Miliary tuberculosis. Acute
miliary sepsis. In the conduct of such patients should focus
Assessment of neurological status, conduct regular inspection of the ocular fundus, because
patients with miliary tuberculosis, tuberculous foci can be detected at
retina. In case of death of such patients should be sure to hold an autopsy
to verify the diagnosis.
9.3 Registration of cases of tuberculosis in HIV-infected persons. Statement on
account in TB dispensaries
Establishing the diagnosis of tuberculosis in HIV-infected persons by
tuberculotherapist and approved the decision TSVKK TB
dispensary. Once the diagnosis of TB patients are registered in
TB clinics (see "Clinical observation of patients
TB with HIV co-infection ")
Patients with tuberculosis and HIV co-infection had come from
Prisons also are registered in the territorial
TB clinics (surgeries). Information about patients
released from prison, including the address of their residence,
transferred from prison to the territorial TB
dispensaries, which are associated with patients and organize them further
observation and treatment
122
Registration of cases of tuberculosis carried out in the territorial Journal
register (TB 03) in accordance with the classification of cases of tuberculosis
approved by order of the current tuberculosis Republic of Kazakhstan.
9.4 Treatment of tuberculosis in HIV - infected patients and monitoring
treatment
Establishing a therapeutic category and the appointment of chemotherapy treatment of HIVinfected with TB by TB doctors
TB facilities.
Treatment of new cases of pulmonary tuberculosis in HIV-infected patients
be performed during Category I, regardless of the prevalence of
process and the presence of bacteria. Treatment of recurrent cases
occurs in the regime II category. The intensive phase of treatment I
therapeutic category can be extended to 4 months, inclusive,
patients with Category II - up to 5 months, inclusive. Treatment of Category III for
TB patients with concomitant HIV - is not used.
Treatment of tuberculosis in the intensive phase of HIV-infected persons by
in the territorial TB hospitals. It is recommended to avoid
transporting patients over long distances, as it is
burdensome for both the patient and for staff.
Acceptance of anti-TB drugs in intensive, and in supporting
phase, is under the direct supervision of health workers.
In conducting the treatment of HIV-infected patients, preference should be
give non-injecting forms (tablets, capsules) and other antidrugs. However, if the patient has chronic diarrhea, absorption
drugs in the gut is disturbed, and this may be the cause
ineffectiveness of therapy. In such cases, parenteral
antituberculosis drugs.
Doses of drugs in the intensive phase are calculated on the initial weight of the patient before
start of treatment.
9.4.1 Treatment in special situations
Given that patients with tuberculosis and HIV co-infection is often
found lesions of the liver and kidneys, associated with other opportunistic
infections, hepatitis transferred or ongoing anti-retroviral therapy,
they can be a bad standard modes of TB therapy. At
intolerance or poor tolerance to standard schemes are appointed
below sparing chemotherapy regimens (WHO, 1998, 2006).
Chronic liver disease - (chronic hepatitis, cirrhosis, and in cases
when the activity of alanine aminotransferase (ALT) three times higher than normal.
Patients should:
- Periodically (at least once a month, according to testimony - often) to control
Indicators of liver tests (bilirubin in the blood, ALT,
AST, thymol)
- In chronic liver disease in remission may be appointed
standard mode of therapy: 2 (4) HRZE / 4 (7) HR
- In case of intolerance of the regime in the intensive phase of isoniazid appointed
combination with rifampicin, plus one or two drugs that do not possess
hepatotoxicity, such as streptomycin or ethambutol (streptomycin more
2 months is not appointed). May apply the following treatment regimens:
Preferred regimen: 2 HRSE / 1 (2) HRE / 6 (7) HR
124
The first alternative scheme: 2 HSE / 10 Do not
The second alternative scheme: 9 RE (rifampicin and ethambutol - 9 months)
When treating patients with chronic hepatitis B with acute illness
should follow the recommendations for acute hepatitis.
Acute hepatitis
If possible, it should be postponed TB treatment until resolution of acute hepatitis. If
TB treatment can not be delayed or terminated, is the most secure
Combined therapy with streptomycin and ethambutol (with a maximum
The duration of intake of these drugs for 3 months, until resolved
acute hepatitis). Maintenance phase is carried out within 6 months of isoniazid and
rifampicin. Treatment Plan: 3 SE / 6HR;
Renal failure
Renal insufficiency is to increase blood creatinine
up to 130-160 mmol / liter. Such patients should regularly monitor the function
Kidney - monthly to determine the level of creatinine in the blood.
Since isoniazid, rifampicin and pyrazinamide are removed from the body of gall
patients with renal failure, these drugs can be given in standard
dosage. Patients with severe renal insufficiency with isoniazid
should receive pyridoxine.
Streptomycin and ethambutol are allocated by the kidneys. If possible
regular monitoring of renal function streptomycin and ethambutol can be included in
schemes of chemotherapy in these cases, they can be assigned fractionally.
The preferred regimen for patients with renal insufficiency:
2 (4) HRZ / 6HR
Alternative regimen for patients with renal failure (if
possible to monitor renal function):
2 (4) HRZE / 4HR
Pregnancy
The following standard treatment for Category I or II. Drugs used in
normal doses. Streptomycin in pregnancy is not appointed to the danger
neuritis of the auditory nerve in the fetus.
With HIV-infected women breast-feeding is prohibited in connection with
risk of HIV infection in a child through breast milk. Children
born to HIV-infected mothers, appointed artificial
feeding.
9.5 Recommendations for prophylactic use of cotrimoxazole
125
Throughout the course of treatment of tuberculosis - and in the intensive and
maintenance phase, all persons living with HIV / AIDS, is appointed
receive cotrimoxazole prophylaxis. The use of cotrimoxazole prophylaxis contributes
prevention of pneumocystis carinii pneumonia, streptococcal (pneumococcal)
pneumonia, toxoplasmosis, salmonellosis, isosporiasis, malaria. Cotrimoxazole
appointed at a dose of 160/800 mg 1 time a day at a time. If using tablets
cotrimoxazole to 0,48 gr. with the content in one tablet 80 mg. trimethoprim and 400
mg. sulfamethoxazole, the adult is appointed by 2 tablets 1 time a day, every day.
Children cotrimoxazole appointed from the age of 4-6 weeks and older. Doses
cotrimoxazole prophylaxis for children is 150 mg trimethoprim + 750 mg
sulfamethoxazole per 1 square meter of body surface child per day, or 4 mg
trimethoprim and 20 mg sulfamethoxazole per 1 kg of weight per day. Thus, a child weighing 10 kg
assigned half tablet containing 80 mg trimethoprim and 400 mg
sulfamethoxazole. This daily dose is given in one step 1 times per day or divided into
2 divided doses (morning and evening). The drug is taken by mouth 3 times a week
Mondays, Wednesdays and Fridays.
Children over 12 years of cotrimoxazole is assigned the same dose as adults - 2
tablet (1 tablet - 0.48 grams) 1 times a day or 3 times a week.
Cotrimoxazole for chemoprophylaxis ordered antiagencies, based on the number of HIV - infected persons, patients
Tuberculosis, taking into account the forecast growth in the number of persons with comorbidities.
After the treatment of tuberculosis whether to continue receiving
cotrimoxazole decides physician - infectious diseases.
9.6 Recommendations for the use of glucocorticoid drugs for tuberculosis
in combination with HIV -
Glucocorticoids are immunosuppressants and may increase the risk
adherence of opportunistic infections in patients with tuberculosis
concomitant HIV - infection. However, their use in the following
cases is appropriate and beneficial impact on the course of tuberculosis,
even in the presence of concomitant HIV - infection.
The effective dose of prednisone for tuberculosis in adults is a dose of 20-30 mg
day. However, rifampicin activates liver enzymes that destroy prednisolone,
therefore, patients receiving rifampicin, appointed by the dose of prednisolone
should be 2 times higher, ie 30-60 mg per day. Table 24 shows the indications for
the use of glucocorticoids in tuberculosis and doses of prednisolone for adults and
children. (Source: TB / HIV. A Clinical Manual. Second edition. WHO, 2004, p. 121)
Table 24 - Indications for use of glucocorticoids in tuberculosis and
doses of prednisolone for adults and children
D on r s s r e a n Indications and r o l o n a:
Application
glyukokortikoidov
Adult Children
Tuberculous
meningitis
60 mg per day for 4
weeks, then stepped
dose reduction during
weeks.
1-2 mg per 1 kg of weight per day
4 weeks, then
stepwise dose reduction
a few
weeks.
Tuberculous
pericarditis
60 mg per day for 4
weeks, then 30 mg
more within 4 weeks
then stepped
dose reduction during
weeks.
1-2 mg per 1 kg of weight per day
4 weeks, then
0,5-1 mg per 1 kg of weight per day
more within 4 weeks
then stepped
reduction in
weeks.
Tuberculous
exudative
pleurisy
30 mg / day for 1-2
weeks, then stepped
dose reduction within 1 2 weeks.
0,5 - 1 mg per 1 kg of weight
day for 1-2 weeks
then stepped
dose reduction within 1 2 weeks.
9.7 Clinical supervision for tuberculosis patients and persons
borne tuberculosis in the presence of concomitant HIV - infection
Clinical supervision for tuberculosis patients and persons with a history
tuberculosis, in the presence of concomitant HIV - infection, conducted in
accordance with the order of the tuberculosis RK.
Secondary chemoprophylaxis of tuberculosis (TB after an attack) HIV
- Infected persons are not carried out.
HIV - infected persons (children, adolescents, adults) who have identified
family, apartment or industrial contact with diseased lung or
extrapulmonary TB (irrespective of the presence of bacteria in a patient)
held clinical-radiological investigation. Complex diagnostic
Research includes: a TB examination, X-ray examination
light (if it was made 4 or more months ago), complete blood count.
In the presence of cough with phlegm conducted three times in the sputum
AFB. In the presence of cough and no sputum examined washings
bronchi. More studies are indicated. Conducting tests
PPD is not mandatory. Persons (children, adolescents, adults) have
which as a result of comprehensive research diagnosis of tuberculosis is excluded,
regardless of tuberculin sensitivity, designated course
chemoprophylaxis.
127
9.8 Identification of HIV - infection in TB patients
In accordance with applicable in the territory of the Republic of Kazakhstan "Rules
medical examination to detect the virus
Human immunodeficiency ", approved by Order of the Ministry of Health of RK № 575 from 11.07.2002
PM, the presence of tuberculosis of any localization - as pulmonary and
extrapulmonary - an absolute indication for HIV testing.
HIV testing is conducted after the diagnosis of tuberculosis. In
Further, if the patient continues to occur in the active group
tuberculosis dispensary, HIV testing is conducted annually.
HIV testing is carried out after pretestovogo counseling.
TB patients, children also are tested for HIV. In children
the age of 18 months for a diagnosis using polymerase
chain reaction (PCR) to detect HIV PNK, and in children 18 months and older
using enzyme-linked immunosorbent assay (ELISA) followed by confirmation
result in the reaction of the immune blotting.
Before the children of an HIV test should be pretestovoe
consultation with parents.
Upon receipt of a negative test result the patient necessarily being
posttetstovoe counseling, during which he reported the test result,
explained that a negative test result may be due to both
called period of "seronegative window", offers recommendations to repeat
study after three months, and discussed HIV prevention infection.
Upon receiving a positive HIV test result in the immune response
blotting information about the patient from the Republican Center for AIDS is transmitted:
a) The agency sent the blood for the study;
b) in the provincial (municipal) Centers for AIDS.
Provincial (municipal) AIDS centers directly or through KIZy during
weeks after receipt of information about positive results in the reaction
immune blotting, organize patient survey infectious diseases, in
which is carried out post-test counseling.
Infectious diseases doctor after examining the patient records in the history of the disease:
detailed clinical diagnosis of HIV - infection, diagnosis of existing
opportunistic infections, in writing makes recommendations
antiretroviral therapy (ART), as well as treatment and prevention
opportunistic infections.
128
9.9 Antiretroviral therapy of HIV - infection in patients with concomitant
Tuberculosis
9.9.1 General
Detection of tuberculosis in HIV-infected patient, irrespective
localization of tuberculosis process and clinical forms of tuberculosis, he
should immediately start TB treatment.
Antiretroviral therapy (ART) should not start simultaneously with
antituberculosis therapy. ART appointed after the sick
good tolerability of anti-TB drugs through various periods
from the beginning of antituberculosis therapy (see table 25). In earlier
appointment of ART, and also if ART is appointed TB
concurrently with TB therapy, there is a danger of a
the patient's immune reconstitution syndrome, which is characterized by
increased inflammatory reaction in the zone of tuberculous inflammation and may
pose a direct threat to the patient's life.
The timing of the appointment (ART) to TB patients with HIV coinfection in each case taken together doctor
infectious diseases and phtisiatry. To ART and dose of antiviral drugs
appointed by infectious diseases.
Table 25 - Terms beginning antituberculosis and antiretroviral therapy
HIV-positive patients with concomitant TB
Number of TB and
the number of CD-4 lymphocytes
blood
ProtivotuberKuleznev
therapy
Antiretroviral therapy (ART)
1.
Extrapulmonary TB, a combination
pulmonary and extrapulmonary TB,
generalized TB
miliary TB
disseminated TB
lungs, caseous pneumonia.
(Regardless of the number of CD-4
lymphocytes in the blood)
Start
immediately
2.
Tuberculosis, except
Forms listed in
paragraph 1 (if the number of CD-4
lymphocytes in the blood <200
1 ml (1mm3).
Start
immediately
Start as soon as it reached
good tolerability
antituberculosis drugs
but not earlier than 2 - 8 weeks
from the beginning of TB
therapy.
3.
Tuberculosis, except
Forms listed in
paragraph 1. (Number of CD-4
lymphocytes in the blood of 200 -350
in 1 ml.)
Start
immediately
Start ART after completion
intensive phase
antituberculosis therapy
4.
Tuberculosis, except
Forms listed in
paragraph 1. (Number of CD-4
lymphocytes in the blood of> 350 in 1
ml.)
Start
immediately
Add ART to complete
full course
antituberculosis therapy.
Monitor the number of CD-4
lymphocytes in the blood. With their
decline <350 cells in 1 ml,
consider the initiation of ART.
129
If HIV infection is detected in TB patients already receiving
TB treatment should be continued antituberculous
therapy and follow the recommendations on ART in table 25.
If tuberculosis was diagnosed in HIV - positive patients already receiving ART,
immediately connect TB treatment and continue
ART. In this case, if the present pattern of TB therapy
rifampicin, and in the scheme of ART there nevirapine, it is preferable to replace
Nevirapine Efavirenz (EFV), abacavir (ABC) or Kaletra (LPV / rtv + rtv).
Antiretroviral therapy of HIV - positive patients with tuberculosis
organized and carried out anti-personnel agencies or
general medical service agencies, depending on where a person with TB
currently receiving anti-tuberculosis therapy. After completion of the course
antituberculosis therapy continuation of antiretroviral therapy
by medical institutions, where the patient is observed
treated on the profile of the disease.
Anti-establishment (TB hospitals, dispensaries) and
general medical service agencies receive antiretroviral drugs in
regional (provincial, municipal), TB dispensaries, where these
drugs are delivered from the regional AIDS centers.
9.9.2 ART regimens first-line combination of HIV infection and tuberculosis
(For patients receiving rifampicin)
The preferred first-line regimens:
1. Zidovudine (AZT) + Lamivudine (3TC) + Efavirenz (EFV)
2. Zidovudine (AZT) + emtricitabine (FTC) + Efavirenz (EFV)
3. Tenofovir (TDF) + Lamivudine (3TC) + Efavirenz (EFV)
4. Tenofovir (TDF) + emtricitabine (FTC) + Efavirenz (EFV)
If Efavirenz is not available, then the absence of other alternatives, it can be
replaced with nevirapine (NVP). However, it should be remembered that in the presence of
rifampin serum concentration of nevirapine decreases by 37%. So
if the patient receives rifampicin, the use of nevirapine should be avoided.
In addition, nevirapine may have acute hepatotoxicity, which
manifested in high levels of CD-4 lymphocytes in the blood. Therefore, nevirapine is not
should be used in men with the number of CD-4 lymphocytes in the blood of 400 and more cells
in 1 ml and in women with the level of CD-4 lymphocytes 200 and more cells in 1 ml.
Alternative first-line regimens:
Zidovudine (AZT) + Lamivudine (3TC) + Abacavir (ABC)
Zidovudine (AZT) + Lamivudine (3TC) + Tenofovir (TDF)
Women of childbearing age Efavirenz can be given only if
reliable contraception.
Efavirenz is contraindicated during pregnancy because of the risk of teratogenicity
action. In pregnant women with tuberculosis safe circuit:
Zidovudine (AZT) + Lamivudine (3TC) + Abacavir (ABC);
Currently Efavirenz is not recommended for children under the age of
three years. Children under the age of three years of ART performed a combination of:
Zidovudine (AZT) + Lamivudine (3TC) + Abacavir (ABC).
If the patient is receiving one of the first-line ARV regimens, develops
tuberculosis, and if it is found in the absence of other signs
130
immunodeficiency, it is not an indicator of inefficiency of the scheme.
Go to the schemes of the second number is not shown.
9.9.3 Second-line ART regimens with a combination of HIV infection and tuberculosis
(For patients receiving rifampicin)
Preferred schemes of the second series:
1. Abacavir (ABC) + Didanosine (ddi) + lopinavir (LPV) / Ritonavir (rtv) +
Ritonavir (rtv)
2. Tenofovir (TDF) + Didanosine (ddi) + lopinavir (LPV) / Ritonavir (rtv) +
Ritonavir (rtv)
In ARV for both first-and second-line patients with renal
failure to avoid the appointment of tenofovir (TDF) in connection with
its nephrotoxicity.
Alternative schemes of the second series:
Abacavir (ABC) + Didanosine (ddi) + Saquinavir (SQV) + Ritonavir (rtv)
Tenofovir (TDF) + Didanosine (ddi) + Saquinavir (SQV) + Ritonavir (rtv)
Using the above schemes, as the drug of first-and second
series, correction doses of rifampicin is not required. However, rifampicin reduces
concentration in the blood of nonnucleoside reverse transcriptase inhibitors
(NNRTIs): Efavirenz (EFV), nevirapine (NVP) and protease inhibitors (PI):
lopinavir (LPV), saquinavir (SQV) and ritonavir (rtv). In turn, these same
medications can reduce the blood concentration of rifampicin. So
rifampicin in combination with NNRTIs and PIs should be taken daily as a
intensive, and in the maintenance phase of TB therapy.
The prevention of superinfection with the same or another subtype of HIV and
The prevention of superinfection with the same or another subtype of HIV and
pathogens of sexually transmitted infections, all women with
associated pathology of HIV / TB is recommended to use condoms.
If patients receiving TB treatment and ART,
diarrhea occurred as a manifestation of side effects of antiretroviral
drugs, ART should be suspended until the disappearance of gastrointestinal disorders, not interrupting while TB treatment. At
This anti-TB drugs that are injectable forms of release,
be given by injection.
9.9.4 Doses of antiretroviral drugs for adults and adolescents over
13 years:
- Zidovudine (AZT): 300 mg x 2 times a day
- Lamivudine (3TC): 150 mg x 2 times a day, or 300 mg x 1 time per day
- Efavirenz (EFV): 600 mg x 1 time per day, is better at night
If the patient's body weight over 60 kilograms and / or the patient takes rifampicin,
Efavirenz increases the dose to 800 mg x 1 time per day, as
Rifampicin reduces the concentration of Efavirenz in the blood.
- Emtricitabine (FTC): 200 mg (1 capsule) x 1 time per day
- Tenofovir (TDF): 300 mg (1 tablet) x 1 time per day
- Nevirapine (NVP): 200 mg (1 tablet) x 1 time per day during the first 14 days,
then 200 mg (1 tablet) x 2 times a day continuously
- Abacavir (ABC): 300 mg (1 tablet) x 2 times a day
- Didanosine (ddi): 400 mg (1 tablet) x 1 time per day, if body weight <60kg, then by
250 mg (1 tablet) x 1 time per day
(When using didanosine (ddi) in combination with tenofovir (TDF) greatly increases
the risk of toxic pancreatitis, and therefore should reduce the dose of didanosine. When appointing a
tenofovir dose didanosine are:
250 mg X 1 times per day for patients weighing 60 kilograms or more
131
125 - 200 mg X 1 times per day for patients weighing <60kg
Didanosine should be taken 2 hours after eating).
- Lopinavir (LPV) / ritonavir (rtv) + ritonavir (rtv) (400 mg/100 mg and 300 mg) x 2
times a day
(In the appointment of lopinavir (LPV) in combination with ritonavir (rtv) at doses (400 mg lopinavir +
100
mg ritonavir) x 2 times a day is recommended to additionally appoint ritonavir (rtv) at a dose of 300
mg x 2 times a day, so the total dose of ritonavir is: 400 mg x 2 times a day
(Superbustirovanny lopinavir). This requires careful monitoring of liver function and
the level of lipids in the blood.
- Saquinavir (SQV) + ritonavir (rtv) (400 mg + 400 mg) x 2 times a day;
(When using saquinavir (SQV) recommended that its combination with ritonavir (rtv) 400 mg
each drug (superbustirovanny saquinavir) x 2 times a day. It also requires
careful monitoring of liver function.
The use of protease inhibitors superbustirovannyh allows leveling reduces
effect of rifampicin on their concentration in the blood).
In this protocol are not given doses of antiretroviral drugs,
used in children. Antiretroviral therapy of HIV - infected children
designated infectious diseases physician, a pediatrician in accordance with standard
WHO protocols. (National Protocols on Treatment and Care
HIV - infection and AIDS, Protocol № 11 for the WHO European Region
"Treatment and care for HIV / AIDS in children", 2006)
9.9.5 Syndrome reconstitution of the immune system
Syndrome of reconstitution of the immune system is a paradoxical
clinical response arising from HIV - infected persons with
related opportunistic infections in response to the beginning
antiretroviral therapy. It develops in approximately one third of patients and
shows a temporary increase of symptoms of opportunistic infections
start taking antiretroviral drugs. Patients with tuberculosis
concomitant HIV - immune reconstitution syndrome
develops at the same time the beginning of TB treatment and ART
reflects restores the ability of the immune system to form
delayed-type hypersensitivity reactions to antigens of mycobacteria.
Clinical manifestations of syndrome range from minor intoxication to
high fever with the development of peripheral lymphadenopathy, expressed
growth of infiltrative changes in the lungs, and in some cases progression of specific foci in the central nervous system. In
the most severe cases of immune reconstitution syndrome, the system is
an immediate threat to the life of patients. In order to prevent it
development of antiretroviral therapy, even in cases where it is certainly
shown, should begin not earlier than 2-8 weeks after the
TB therapy, when as a result of antidrugs of the antigenic load intensity decreases. In severe
reconstitution syndrome, immune system should receive prednisolone in
dose of 1 mg per kilogram of body weight within 1 - 2 weeks followed by a step to
cancellation.
9.9.6 Specific prevention of tuberculosis in HIV-infected
9.9.6.1 Immunization by administration of the vaccine BCG.
Infants born to HIV-infected mothers in the absence
neonatal clinical signs of HIV infection and other contraindications
to the introduction of the vaccine BCG, instilled a standard dose of the vaccine BCG (0,05 mg)
132
intradermally once, in a calendar period - during the first four to six
days of life.
Infants born to HIV-infected mothers not vaccinated in
specified time, may be vaccinated during the first four weeks of life
(Neonatal period), without prior Mantoux test.
After the fourth week of life BCG vaccine to children born
HIV-infected mothers are not allowed because if a child
infected with HIV, increasing viral load (during the day formed
about 1 billion new virus particles) and the progression of immunodeficiency may
lead to the development of generalized infection BCG. For the same reason,
conducted booster BCG children with undeveloped
signs post-vaccination until the child reaches the age of 12 months, and in
some cases - 15-18 months, when it can be made final
conclusion that infected child immunodeficiency virus or not.
Children born to HIV-infected mothers not vaccinated at birth
vaccine, BCG, or graft, but with undeveloped post-vaccination marks, the
which during the re-testing for HIV by the age of 12 months (according to
studies of viral load), and in some cases by the age of 15-18 months
(According to ELISA), HIV infection is excluded, grafted standard dose
BCG vaccine after prior Mantoux test with 2 ie with its negative
results.
BCG re-vaccination of HIV - positive children and adolescents are not carried out
the risk of generalized infection BCG against a background of increasing
immunodeficiency.
If a child is born to HIV infected mother, but he is not HIV infected, then revaccination BCG he held in the calendar period after
preliminary tests with negative Mantoux its results.
9.9.6.2 Chemoprophylaxis
The aim of chemoprophylaxis is the elimination of latent
infection.
Table 26 - Contingents of HIV - infected persons to be
chemoprophylaxis of tuberculosis, and modes of chemoprophylaxis
№
Serial
Contingents of HIV infected persons to be
chemoprophylaxis of tuberculosis:
Profiles chemoprophylaxis
1. Normal Alternate
All newly diagnosed HIV infected persons (children,
teens, adults), including
previously undergone tuberculosis, with
Establishment of HIV-positive
status in the immune response
blotting, regardless of
Isoniazid (H) 5 mg per 1 kg of weight, but
not more than 0,3, the
day by mouth,
daily,
combined with the reception
Rifampicin (R)
appropriate
weight and age
Recipient dosages
daily by mouth, in
within 4 months.
133
2.
tuberculin sensitivity.
HIV - infected persons (children,
teens, adults), including
previously undergone TB
regardless of the tuberculin
sensitivity, in establishing
they have contact with patients with pulmonary
or extrapulmonary tuberculosis
(Regardless of
of bacteria in a patient).
pyridoxine 25 mg per day mouth, daily,
within 6 months.
Doses of rifampin,
used for
chemoprophylaxis,
correspond to doses
applied to
holding
intensive phase
Chemotherapy
tuberculosis.
This scheme
applies only
with proven
hypersensitive
isoniazid for
decision TSVKK
protivotuberkuleznog
of the dispensary. It is not
should be applied in
persons receiving
nevirapine.
All HIV-infected individuals (children, adolescents, adults), not
staying in contact with the patients of tuberculosis chemoprophylaxis
TB is carried out only once in determining HIV-positive
status in the reaction of the immune blotting. Her appoint tuberculotherapist
territorial TB dispensaries and carry out AIDS centers or
establishment of the general medical service (based on the greatest convenience for those
receiving chemoprophylaxis). Mantoux Tuberculin test for selection
contingent on chemoprophylaxis is not used. HIV infected persons who do not live in contact with a TB patient in
the period of chemoprophylaxis on the account in TB
dispensaries are not taken.
HIV - infected persons living in contact with sick
pulmonary or extrapulmonary TB (irrespective of
of bacteria in the patient) chemoprophylaxis of tuberculosis as
conducted once in establishing contacts with patients. If HIV infected remains in contact with the sputum in
Over the years, the TSVKK TB dispensary can take
the holding of repeated courses of chemoprophylaxis. Tuberculin
Mantoux test for the selection of contingents to chemoprophylaxis among
HIV-infected persons living in contact with a TB patient,
also not used. All HIV - infected persons in contact with
TB patient, observed in a tuberculosis dispensary.
Preparations for chemoprophylaxis they can get directly
TB Dispensary, Territorial AIDS center, office
infectious diseases, territorial primary health care facilities (based on
maximum convenience for those receiving chemoprophylaxis).
Chemoprophylaxis appointed territorial TB doctors
TB dispensaries only after the exclusion from HIV infected persons for active tuberculosis according to a comprehensive clinical
radiographic examination. This makes TB recording
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medical card patient that TB was ruled out, and indicates the regime
chemoprophylaxis (medication, dose, duration of admission).
Chemoprophylaxis of TB HIV - infected persons, being
isoniazid for 6 months, in combination with pyridoxine -25 mg
(Standard mode). In the absence of pyridoxine, it can be done without
pyridoxine. Chemoprophylaxis can also be conducted with rifampicin in
4 months (alternate mode). Alternative transport regime
worse than the standard, because hepatotoxic effect of rifampicin, which
could escalate on a background antiretroviral therapy, so an alternative
regime should be imposed only in exceptional cases - in case of intolerance
isoniazid, to address TSVKK TB dispensary.
Receiving drugs for chemoprophylaxis on a daily basis.
Doses of drugs - isoniazid and rifampicin are appointed according to
age and weight of patients and are consistent with doses of these drugs used
during the intensive phase of chemotherapy of tuberculosis.
Preparations for the chemoprophylaxis of HIV - infected persons not
staying in contact with a TB patient, ordered
Territorial AIDS Center, according to data on the alleged
the number of new cases of HIV - infection in the year.
Preparations for the chemoprophylaxis of HIV - infected persons,
staying in contact with a TB patient, ordered
anti-territorial institutions.
9.9.6.3 Prevention of HIV - infection in TB patients
HIV - infection in TB patients is essential
section of the TB program. Its main elements are:
• Conduct among TB patients, both in hospitals and in the
outpatient phase of treatment, individual and group sessions, discussions on
HIV - infection, its adverse effect on the course of tuberculosis and
measures to prevent it
• Production and dissemination of TB patients booklets, leaflets,
Posters on prevention of HIV - infection, in particular, training
methods of safe sex
• Active cooperation of TB programs with
Harm reduction: the organization of tuberculosis hospitals and post
outpatient treatment of tuberculosis needle exchange points,
free issue of condoms
• Distribution among TB patients understand the methods
post-exposure prevention of HIV - infection, venue and
Access to post-exposure prophylaxis for patients
Tuberculosis
The activities for the prevention of HIV - infection in patients
TB control programs are actively cooperating with
international and nongovernmental organizations with the resources
public and private funding.
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10. Registration and reporting system
The purpose of the information system is the possibility of obtaining data for
quantitative assessment and monitoring at different levels to identify
patients, outcomes of treatment and evaluation of the program as a whole.
This section describes the main provisions of the medical records and
forms of accounting and reporting documents that are used to manage all patients
TB organization.
The order of completion accounting and reporting documents submitted to the methodological
Guide: Using accounting and reporting documentation
TB control program of the Republic of Kazakhstan ".
Records: Medical record with TB - TB 01, "Map
monitoring dispensary contingent "- TB 16 and" Medical Card
Patient category "TB 01 - category IV are the input forms in the
computer program for tracking TB patient - National
Register of patients with tuberculosis of the Republic of Kazakhstan. To obtain reliable and
complete information on the epidemiological situation of tuberculosis in the country
(Province, district) should be timely and correct completion of all registrationreporting forms.
10.1 The records
10.1.1 A medical patient Tuberculosis - TB 01
To be completed for each case of tuberculosis: a new case, re-treatment, and
to persons identified posthumously, on the basis provided by institutions
of MH's and other agencies document - "Notification of patients with first in
life of a diagnosis of active tuberculosis, venereal disease,
Trichophyton, crusted ringworm, scabies, trachoma, mental illness, "(Form № 089 / y).
Map of TB 01 is filled in the residence after the patient phthisiatrician
confirm the diagnosis of TB in TSVKK and is designed for registration
information about the patient during the entire course of chemotherapy.
Patients' medical records Tuberculosis - TB 01 is an input document
a computer program for tracking TB.
Conduct TB 01 and the organization of data input
in an electronic database:
1. After establishing the diagnosis of TB and patient registration
Journal of TB 03
2. By the end of intensive phase of treatment
3. At the end of treatment and determine its standard outcome
10.1.2 Map monitor dispensary contingent - TB 16
Map of TB 16 is to record information about patient
TB organizations throughout the observation period on
dispensary. Kept in the dispensary department instead of the forms 030-4 / Y
approved by order of the Ministry of Health of RK № 332 from 08 july 2005. Filled by the precinct
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phthisiatrician the entire dispensary contingent, taken on the account of the place
actual residence.
Map of TB 16 is an input document into a computer program for tracking
TB.
Quarterly file TB 16 should check for each phthisiatric
site with maps of TB 01 and TB 01 - category IV, represented by doctors PHC
and replenishes the necessary information.
10.1.3 A medical patient category of TB 01 - Tier IV
Medical histories of patients in category IV contains basic information about the patient
category IV, on his previous treatment, biomedical,
epidemiological, social data of the research and other
important information.
Map of TB 01 - Tier IV completed for each patient, transferred to
category IV, consisting of the IB or IG dispensary group and is
input documents into a computer program for tracking patient categories
IV.
Conduct TB 01 - Tier IV and organization of data entry
in an electronic database:
1. After registering the patient in the register of patients with category IV
- TB 11
2. After each new solution TSVKK change of tactics of treatment
10.2 Reports Documentation
10.2.1 Quarterly Report on registered patients with tuberculosis - TB
07
Quarterly Report TB 07 captures the number of reported cases
TB on old process (new and repeat), localization (pulmonary and
extrapulmonary) on mycobacterium (positive and negative smear), in
During the past quarter. The report also shows the distribution of all
TB cases by category, gender and age. TB 07 enables
quarterly review all reported cases of tuberculosis
(Other than translations), to identify trends and forecast in the incidence
Tuberculosis, which allows us to take the necessary measures.
TB 07 also contains information about the results of testing TB patients for HIV.
10.2.2 Quarterly report on smear conversion after
intensive phase of treatment in the mode I and II category - TB 10
Quarterly report on sputum conversion of TB 10 is designed for intermediate
assess the effectiveness of treatment of patients with positive results
smear microscopy. Be drawn up for each cohort, in accordance with TB
07. Given that the intensive phase of patients of category I is extended to 4
months in patients with Category II - up to 5 months inclusive, the quarterly report
on the conversion is made after 2 quarters after the end of the reporting period.
Thus, for the cohort of patients I and II categories, begin treatment in the 1 st quarter
(January-March) Quarterly Report on conversion will be in the 3 rd quarter
(September).
10.2.3 Quarterly report on the results of treatment of patients with tuberculosis - TB
08
Quarterly Report TB 08 contains information about the standard of treatment outcomes
TB patients registered 12-15 months ago, and gives
opportunity to determine what program a success rate of treatment.
10.2.4 Annual report of new cases and relapses of the disease active
TB - a form number 8
In the reporting form number 8 represented the number of patients with first ever
a diagnosis of TB relapses and MDR-TB, taken for treatment
reporting year. Form approved by Order № 513 MH RK dated 17 August 2007. On
Amending the Order of the Republic of Kazakhstan Ministry of Health of October 31, 2006 № 509
"On approval of administrative reporting forms of organization
Health.
The report can be compiled for the territory on the basis
received from agencies of Kazakhstan Ministry of Health and other agencies "Notice
patients with newly diagnosed in the life of active tuberculosis,
venereal disease, Trichophyton, crusted ringworm, scabies, trachoma, mental
disease "(Form № 089 / y).
10.2.5 Annual report on tuberculosis - the form number 33
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Form number 33 approved by Order № 513 MH RK dated 17 August 2007. "On Making
amendments and additions to order MH RK on 31 October 2006goda № 509 "On
Approval of administrative reporting forms Health Organization.
Reports form number 33 is made according to patients' medical records
Tuberculosis - TB 01, TB patient's medical history category IV TB 01 category IV, Maps monitoring dispensary contingent - TB 16.
10.2.6 Quarterly Report registering patients with category IV - TB 07 Category IV
TB 07 - Category IV - Report on the number of patients registered on
Category IV for the quarter and receiving specific chemotherapy drugs
first and second rows. Quarterly Report also shows the number of patients
with confirmed multiresistance (TBMLU).
10.2.7 Quarterly report on sputum conversion after the completion of intensive
phase treatment of patients with category IV - TB 10 - Tier IV
Quarterly report on sputum conversion of TB 10 category IV is for
interim evaluation of the effectiveness of treatment of patients with bacterial.
Be drawn up for each cohort, in accordance with TB 07-category IV. Given
that the minimum duration of intensive phase of Category IV, in
treated SWR is 6 months and the conversion is estimated by
cultural studies (seed), the quarterly report on the conversion
drawn up after 9 months after the end of the reporting period. Example:
TB patients who started treatment during the I quarter of the year (January - March), should
be included on the "Quarterly Report of TB 10 - Category IV» in 1st quarter
next year.
10.2.8 Quarterly report on treatment outcomes in patients with category IV - TB 08 Category IV
TB Report 08-IV category reflects the standard treatment outcomes of patients
Category IV and is made after 24 and 36 months. Typically, most
patients complete treatment after 24 months. Some patients may
continue chemotherapy and 30 months. Therefore, the reported TB 08-category
IV compiled twice - at 24 and 36 months.
10.2.9 Report on the use of TAP in the field of medical organizations,
district and village (TVE, PHC), TB 13
This form provides information on the number received,
expended for the TAP and fund anti-TB drugs at the end
reporting period on the regional level (district, PHC). Provided in this
form of information is necessary to monitor the management of
TAP in medical organizations at regional level (district, PHC).
TB Report 13 at the regional level should be submitted on a quarterly basis in regional
Department of Health and National Centre of TB problem
MH RK. At the district level should be submitted monthly to the Regional
TB dispensary. To be filled by a person responsible for the storage and
leave TAP on the regional level, district and village (TVE, PHC)
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Materials Required: "log TB
drugs "," Report on the use of TAP in the field of medical organizations,
district and village (TVE PHC).
11. Tuberculosis prevention
11.1 BCG vaccination and revaccination
11.1.1 The purpose of vaccination and revaccination - active specific prevention
tuberculosis.
11.1.2 Characteristics of the drug
BCG vaccine (Bacielle Calmette-Guerin) is a live mycobacteria
BCG vaccine strain, freeze-dried in 1.5% solution glyutaminata
sodium. Has the appearance of a white porous mass of dried powder or
pill white or cream color. Live Mycobacterium strain BCG,
multiplying in the body of the grafted lead to the development of long-term immunity
to tuberculosis.
BCG vaccine is available in ampoules containing 0,5 or 1,0 mg of dry matter
BCG (10 or 20 doses, respectively). Vaccination dose of BCG vaccine from different
manufacturers contain different amounts of viable bacteria.
The vaccine, which has a crack on the ampoule, without labels or with incorrect
filled with the label, with expired date, as well as to maintain after
Breeding impurities or flakes, is unsuitable for consumption.
Due to the high sensitivity of the BCG vaccine to daylight it should
stored in a dark place in the refrigerator at T ° +5 - +8 ° C. BCG vaccine is stored
and is issued by territorial UGSEN.
In order to avoid contamination is unacceptable to combine in a single day immunized against
tuberculosis with other parenteral manipulations.
Prior to the conversation with the woman in childbirth, the purpose of the use of BCG vaccine,
as well as other vaccinations carried out immediately after birth.
11.1.3 Indications for BCG vaccination
Primary vaccination exercise healthy term infants
children in the 1-4 day of life and premature for achieving weight 2,0 kg, after
inspection pediatrician with obtaining access to vaccination in the history of the newborn, in
the presence and with the written consent of the mother.
11.1.4 Contraindications to BCG vaccination
� Generalized BCG infection, revealed the other children in the family
(The possibility of hereditary immunodeficiency)
� HIV / AIDS
� Prematurity - weight less than 2000 grams., Or gestational age
less than 33 weeks.
� CNS - birth trauma with neurological symptoms
severe.
� intrauterine infection, neonatal sepsis,
� Hemolytic disease of newborn (severe and moderate forms)
� moderate and severe disease, with febrile
temperature and a violation of the general state
11.1.5 BCG Revaccination
A healthy, uninfected children with a negative Mantoux test in
aged 6-7 years (Grade 1) professionals PHC facilities with
ftiziopediatrami VET in schools, while throughout the country
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the first month of the school year (September). In this month at the school conduct
Other vaccinations are prohibited.
The interval between the Mantoux test and BCG revaccination should be no less than three
days and not more than two weeks. If you have medical taps revaccination
should take place immediately after the removal of contraindications.
Other immunizations may be carried out at intervals of not less than 2
months before and after BCG revaccination.
11.1.6 Contraindications to BCG revaccination:
� Infection with Mycobacterium tuberculosis or the presence of tuberculosis in
past;
� positive and doubtful Mantoux
� side effects of BCG vaccination
� generalized BCG infection, revealed by the other members of the family
� HIV
� immunodeficiency states, malignancies
� acute infectious and noninfectious diseases, exacerbation
chronic diseases, including allergies. Revaccination
conducted 1 month after recovery or remission
11.1.7 Responding to the introduction of BCG vaccine
During the child's stay in the hospital doctor (nurse) informed
mother, that 4-6 weeks after intradermal vaccination in a child should
develop local grafting reaction. Immediately after the introduction of BCG vaccine
papule is formed, which dissolves in 15-20 minutes.
Local reaction begins with hyperemia and infiltration (papule), which
transformed into vesicles, pustules, then a scab, which
themselves no longer and begins forming a ridge (95-97%). Described
reactions are the norm and do not require any medical treatment
means.
The most optimal is the diameter of hilum 5-8 mm. In some cases, on-site
introduction of BCG generated apigmentnoe spot (2-3%). Final result
BCG vaccination and revaccination are estimated at 1 year after vaccination for
the size of a ridge.
In the absence of local vaccination reactions of children should be required
accounted for and vaccinated (dovaktsinirovany) repeatedly (once only) after 6 months
without prior Mantoux test, after 1 year - at a negative Mantoux test.
Need to monitor the reaction of peripheral lymph nodes, with
to determine the overall reactions to the vaccine and timely
identification of regional postvaccination lymphadenitis.
Inoculation should undertake a specially trained medical staff
Maternity Hospital (office), care of premature separation, children
clinics, outpatient clinics, health centers, has access to
inoculations, based on the doctor's prescription, in the presence of mother
child in the morning.
Data about the vaccine (producer, series, dose, expiry date, date of vaccination)
145
recorded in the history of the newborn and exchange card, which after discharge
the child from the hospital transferred to a hospital where they live.
Children who have not been vaccinated BCG in the maternity home
vaccinated children's clinic, with up to 2 months of vaccination
carried out without preliminary statement Mantoux test, and after 2 months with its negative result.
Vaccinated children falling from the hospital in terms of contact with
sick - sputum, should be isolated for not less than
2 months in office nursing infants or children's home (in the case
impossibility of isolating the patient of tuberculosis).
If the mother is ill with active tuberculosis, the child be vaccinated
BCG in the absence of contraindications, and then isolated from the mother to
formation of immunity (for a period not less than 2 months). Sick mother
breast-feeding is prohibited.
Persons who are temporarily exempt from vaccinations, should be placed under surveillance and
Accounting and inoculated after complete recovery or removal of contraindications,
including the period of convalescence at least 2 months after the disappearance
clinical symptoms.
Persons with questionable Mantoux 2m before revaccination
(Vaccination), and not covered by the BCG revaccination for various reasons
Mantoux test is put again no earlier than 1 month but within
financial year and with a negative result of its being vaccinated.
Observation of vaccinees (revaccinated) children and adolescents
conducted paediatricians general medical service. It periodically
1, 3, 6, 12 months, check local grafting reaction with registration
its nature and size of accounting forms, 063u, 026u, 112u.
The criteria for assessing the quality of vaccination coverage rates are
BCG vaccination and revaccination of children and adolescents, the proportion of
the formation of scars on his left shoulder after intradermal vaccination
BCG scars the size and severity of post-vaccination tuberculin
sensitivity to dynamics. Percentage vaccination coverage of 97.0% -98.0%
and the percentage of coverage revaccination 95,0% of tuberkulinootritsatelnyh.
11.1.8 Specific prevention of HIV-infected children and
Adolescent
Infants born to HIV-infected mothers, in the absence
have clinical signs of HIV infection and other contraindications to the introduction of
BCG vaccine imparted standard dose of BCG vaccine (0.05 mg or 0,025 mg)
intradermally once in a calendar period.
Infants born to HIV-infected mothers in the unvaccinated
calendar period, may be vaccinated during the first four weeks of life
(Neonatal period) without prior Mantoux test. After
fourth week of life, the introduction of BCG vaccine to children born to HIVinfected mothers will not be allowed because of possible development
generalized BCG infection. For the same reason, shall not reBCG vaccination of children with undeveloped post-vaccination marks (rib) to
146
the child reaches the age of 15-18 months, when it can be made
final conclusion about the infected child immunodeficiency virus
or not. With the exclusion of HIV infection by the age of 15-18 months of BCG
carried out with a negative result of Mantoux test with 2 TE.
BCG re-vaccination of HIV-infected detym and adolescents are not carried out because
the danger of a generalized BCG infection on a background of growing
immunodeficiency.
If a child is born to HIV-infected mother, but he is HIVinfected, BCG revaccination is carried out in the calendar period (6-7 years)
after pre-production with negative Mantoux test its results.
11.1.9 Adverse reactions to the vaccine are relatively rare
and are mostly local in nature:
� postvaccination lymphadenitis
� subcutaneous cold abscesses
� Superficial ulcer
� keloid scar
� The defeat of the bone system (osteitis)
TB should establish the diagnosis based on clinical and X-ray
laboratory examination. Once diagnosed with post-vaccinal
complications should inform the head of the medical institution and
to give notice in UGSEN. For information about the nature of complications recorded in
credential forms 063 / y 026 / y 112 / y. In all children with post-vaccination
complications filled map. Children with post-vaccination complications
are observed in the III dispensary group within 1 year.
11.2 Chemoprophylaxis
Conducted to prevent the development of local tuberculosis.
Chemoprophylaxis is appointed by healthy individuals at risk, who after
comprehensive survey of local tubercular process is not revealed.
The main drug for chemoprophylaxis is isoniazid (H).
Dose of H is assigned at once, daily, at 5 mg / kg (not
more than 0,3 g / day), under the direct supervision of medical staff
the entire period of the course. Duration of chemoprophylaxis
different groups of children is governed by legal documents MZ
RK.
11.2.1 Indications for chemoprophylaxis
� If you bend tuberculin reactions (normergiya, giperergiya) duration
course of chemoprophylaxis is 3 months. To better
tolerability of the drug simultaneously with H prescribe multivitamins, in
of which there are vitamins A and B.
� persons previously infected with Mycobacterium tuberculosis, the detection
hyperergic reaction of isoniazid chemoprophylaxis is held and
ethambutol for 2 months (2NE). Ethambutol is appointed at 15
mg / kg body weight. Before the appointment of ethambutol need advice
ophthalmologist.
147
� Chemoprophylaxis contact persons shown in the presence of superelevation and
hyperergic reactions at the time of taking on the account and once done,
controllable in a sanatorium-type institutions, or
organized children's groups.
� All healthy children under 1 year of life of the foci of tuberculosis infection,
regardless of the patient and the results of bacterial tests Mantoux 2 TE
isoniazid chemoprophylaxis for 3 months (3H) with
compliance with the 2-month intervals after BCG vaccination.
� If the newborn has been in close contact with sick mother before the introduction
BCG vaccine (birth outside the medical establishment, not immunized because
contraindications, etc.), vaccination did not immediately carry out and nominate course
chemoprophylaxis for 3 months isoniazid (3H). After
chemoprophylaxis with negative Mantoux test 2, the graft
BCG vaccine. During the period of chemoprophylaxis and within 2 months after
BCG vaccination is required compulsory isolation of the child from her sick mother.
� If TB in the mother or family members is installed after the newborn
BCG vaccine was not known TB Dispensary,
prophylactic treatment for the child spend 2 months after the introduction
BCG vaccine.
� The fire death of a previously unknown TB Dispensary
the patient, conducted a comprehensive survey of children and adolescents, and
recreational activities - chemoprophylaxis with bends and
giperergii.
� Chemoprophylaxis isoniazid for 2 months to show children and
adolescents infected with Mycobacterium tuberculosis, receiving
basic hormone (cytotoxic) therapy.
� Duration isoniazid chemoprophylaxis - 6 months (
WHO recommendations)
� When adverse reactions to receive H (eosinophilia, allergic
dermatitis, dyspepsia, paresthesia, etc.) should
additional tests (blood, urine). When
adverse reactions of H is canceled for 5-7 days. When allergic reactions
appointed by desensitizing therapy antihistamines.
If you are hypersensitive when reappointing H
chemoprophylaxis canceled. After suffering a viral hepatitis
chemoprophylaxis appointed not earlier than 6 months after
disappearance of all clinical manifestations, the conclusion infectionist.
This category of chemoprophylaxis is held against the
hepatoprotectors.
11.2.2 Contraindications for chemoprophylaxis
� Epilepsy
� Organic CNS
� Diseases of the liver and kidneys non-tubercular etiology with a violation of their
function.
11.2.3 Organization of chemoprophylaxis
Chemoprophylaxis is free, drugs, isolated
centrally from the national budget. TB Dispensary
(Tubbolnitsa, tubotdelenie, tubkabinet) in the annual application for chemotherapeutic
should take into account the need for drugs (H and E) for
chemoprophylaxis.
148
Chemoprophylaxis is appointed and supervised by health workers
TB dispensaries, tubbolnits, tubotdeleny, tubkabinetov.
To carry out chemoprophylaxis medical staff of health centers
outpatient clinics, offices of general practitioners, in schools, child
kindergartens, secondary and higher education institutions under the control of TB
institutions.
Data on chemoprophylaxis recorded in medical records
outpatient (Form 026 / y), the map monitoring dispensary
contingent (TB 16), daily recorded in the list control performed
treatment, carried out under the direct supervision of medical staff.
The effectiveness of anti-TB drugs for the prevention
or treatment of latent infection of multiresistant strains of the Office until
quite clear. Until additional data is not recommended as
common practice of prophylactic treatment of persons in contact with
patients with MDR-TB.
Chemoprophylaxis of HIV infected children and adolescents being
once:
1) all in determining HIV-positive status in the immune response
blotting (not staying in contact with TB);
2) staying in contact with patients with pulmonary or extrapulmonary tuberculosis
regardless of the bacteria.
Chemoprophylaxis of HIV-infected children and adolescents is appointed
TB doctors territorial TB dispensaries only after
exclusion of active tuberculosis according to a comprehensive clinical
radiological investigations and conducted izonizidom (H) at 5 mg / kg
weight (not more than 0,3 g) in combination with pyridoxine -25 mg per day, daily
mode for 6 months. Performed directly in the center of AIDS in
study of infectious disease clinics or in primary health care facilities in
children's organized groups (school, health center, spa, gardens),
colleges, universities, and is under the direct supervision of medical
sisters.
11.3 Indications for the direction of children in tuberculosis sanatorium
agencies
Shows the effectiveness of preventive measures carried out in
children's spa facilities. Isolation tuberkulinootritsatelnyh children
foci of infection in the spa facilities aimed at preventing
infection with tuberculosis. During their stay in contact child
spa facilities, most patients have converted to negative
and they are not dangerous for their children.
Organized TB prevention must first be covered
young children from tuberculosis contacts.
An essential prerequisite for the effective prevention of tuberculosis
is the early identification of infected children. Newly infected
(Turn), TB children are most numerous and troublesome group
dispensary contingent. Timely identification of infected
Tuberculosis children and holding them chemoprophylaxis provides reliable
suppression of tuberculosis infection in the body of the child and prevents the development of
disease.
149
Preventive work among children at high-risk "disease
Tuberculosis should also be aimed at strengthening the immune
Masks
Ordinary surgical masks reduce the likelihood of contamination of airdroplets through sneezing or coughing. Patients with uncontrolled coughing
must wear a mask when you walk on the hospital grounds. Hospital staff
must wear masks when exposure to airborne
infection is inevitable (room sputum, bronchoscopy study).
11.4.3 Defining the focus of tuberculosis and risk factors
Fireplace TB infection - a place of residence (private home, apartment, room
in a dormitory), study, work, leisure-patient sputum.
A prerequisite for infection is contact with infectious patients
tuberculosis. When human contact with the Office come into the risk factors
infection, the risk of tuberculosis and the risk of fatal
outcome.
The main factors determining the risk of contact with the ILO, are the number of
and nature of contacts between infectious patients and susceptible individuals for
unit time contagiousness.
Contact - the interaction between TB patients with bacterial and
people at a distance close enough for conversation or
enclosed space.
Contact person - a person who is and (or) was in contact with
patients isolated in the external environment in the Office.
The risk of infection after an exposure depends on the following
factors:
• the number of infected droplets in unit volume of air, ie the density
infectious particles
• duration of contact of an individual with infectious particles
In order could have been a transfer of infection, TB patients should
into the air infectious particles. Typically, this is only possible in cases
Pulmonary TB. Among patients with pulmonary TB are not all equally may
spread the infection.
Number of Office, found in samples of sputum correlates with infectiousness
patient. The intensity of bacteria are divided into:
• moderate MBT (the exact number of AFB 1 +)
• Massive MBT (2 + to 3 +)
Timely medical intervention and the appointment of the correct
chemotherapy reduces the duration of the period of contagiousness. Where
Chemotherapy is inadequate, there remains a risk of infection of surrounding people.
Under inadequate chemotherapy refers to the wrong combination of TAP
or lack of dose, therapy is also becoming inadequate in those cases
when developing strains resistant to one or more used
antimicrobial, or when patients take their assigned
medication irregularly or at its discretion.
Environmental factors conducive to the spread of infection:
• contact with TB patients within a relatively small private
space;
153
• Lack of proper ventilation, which allows "clean" environment
Wednesday through dilution air or removing droplets containing
Office.
• recirculation of air containing, aerogenically infection.
Factors influencing the risk of disease:
• Re-infection of the Office
• Presence of HIV infection.
• Presence of residual fibrotic changes, concomitant diseases
(Diabetes), malnutrition
11.4.4 The epidemic foci of tuberculosis
The epidemic foci of tuberculosis have spatial and temporal boundaries.
In the spatial boundaries of focus include housing the patient, his place of work,
training, education, treatment, and groups and groups of people with whom he
communicate continuously, periodically or temporarily.
Temporary border focus include two terms: the entire period of communication with the source
Mycobacteria and the duration of incubation in contact. Probability
increased incidence of contact in the outbreak persists for years after
removal of a patient with bacteriological accounting.
In different groups, groups, due to intensive migration
population with a significant number of unidentified sources of infection may
be the group of tuberculosis. They can occur in children
groups, by place of work or study in the social security institutions,
hospitals with a prolonged stay of patients
(Psychiatric and other institutions), in small relatively isolated
localities where conditions exist for frequent and close communication between people.
These foci of tuberculosis requires the commission to train professionals
phthisiatric and anti-epidemic services and development with the participation
administration of the institution (administration of a settlement) plan
on their localization and liquidation.
11.4.4.1 The epidemiological characteristics of foci of tuberculosis infection
Foci of tuberculosis infection is divided into 3 epidemiological groups. Reason for
attributing the fire to one group or another are the following criteria: massive
of bacteria, presence of children and adolescents in the hearth, the presence of harmful habits among
patients and their families (alcoholism, drug addiction), living conditions and
compliance with sanitary and epidemiological rules and
social level of life of the patient and family members.
The first group of epidemiological foci:
• pockets inhabited by patients with massive bacterial
• pockets where there are patients with moderate to bacterial
presence of children and adolescents, pregnant women, alcoholics,
addicts
• centers with poor sanitary conditions,
low life
Frequency of visits: TB doctors, epidemiologists and physicians ftiziopediatry - 1 times
quarter, nurses and assistants epidemiologist - not less than 1 per month.
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The second epidemiological group:
• pockets inhabited by patients with moderate bacterial,
in the absence of the factors listed in the two last
subparagraphs.
Frequency of visits: TB doctors and doctors epidemiologists - 1 time in 6 months;
nurses and assistants epidemiologist - not less than 1 time in 2 months.
Third Epidemiological Unit:
• pockets of the cessation of bacteria, exit, change
permanent residence or death smear (including
patients with unknown dispensary whose tuberculosis was found only
at autopsy);
• pockets of TB, where TB patients are identified
livestock
Frequency of visits: TB doctors and doctors epidemiologists - 1 times per year, medical
nurses and assistants epidemiologist - not less than 1 time per quarter.
Affiliation focus of tuberculosis to one or another group determines the precinct
TB in the compulsory participation of a physician-epidemiologist. This order is preserved under
transfer the focus from one group to another epidemic in the event of changes in
focus conditions, increase or decrease the risk of infection or disease.
11.4.4.2 Duties phthisiatric service work in areas of:
• epidemiological survey focus, risk assessment of infection in the outbreak in
according to risk factors, develop an action plan, the dynamic
observation of the fireplace, the primary focus of survey anthroponotic
TB expedient to carry out specialist Territorial
UGSEN and focus Zoonotic tuberculosis - with specialists phthisiatric,
sanitary-epidemiological and veterinary services
• Hospitalization and treatment of TB patients
• isolation of TB patients within the hearth (if not hospitalized), isolation
Children
• order and organization of the final disinfection, provide ongoing
disinfection and patient education and contact with its methods
• Primary survey of contact
• Monitoring of contact persons and their dynamic examination (holding
fluorographic examination, Mantoux test 2 TE, bacteriological
examination, general clinical tests)
• prophylactic treatment
• education of patients and contact with the healthy lifestyle and
hygiene education
• determine the conditions under which the center can be removed from the epidemiological
Accounting
• filling and maintaining a dynamic map showing characteristics of hearth and
held its activities
In urban areas, remote from the clinic, these activities do
experts in the PHC network guidance to a TB clinic and
epidemiologist GSEN.
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11.4.4.3 Responsibilities of service GSEN to work in areas of:
• conducting epidemiological survey of primary focus,
completes the definition of its borders and developing a plan for recovery,
necessarily in conjunction with phthisiatrician
• maintaining adequate accounting and reporting documentation (f.060 / y, "Map
Epidemiological surveys focus bacillary forms of tuberculosis,
Reports ip. 1 and 2, TB02)
• TB doctors help in organizing and conducting epidemiological
activities focus
• dynamic monitoring in the centers, making additions and changes to the plan
events
• Epidemiological analysis of the situation in the district as a whole in the foci
tuberculosis, evaluation of the foci served
Territory and discussion with TB doctors of this work
• monitoring of the timeliness, quality and completeness of outbreaks in all
complex anti-epidemic measures
The most important condition for successful work in the foci is constant contact phthisiatrician
and epidemiologist, consistency in their actions.
In every case, the first time identified tuberculosis of the respiratory system among the rural residents
territorial GSEN Alerting veterinary services, representatives
which are examined for TB pets in the household patient.
Veterinary Service, GSEN inform the defined event and provide
disseminating information on all cases to identify animals, positive
reacting to tuberculin. Specialist veterinary service makes binding
participate in defining a set of measures in areas of Zoonotic tuberculosis.
11.4.5 Registration and accounting foci of tuberculosis
For each patient with the first-ever diagnosed active
tuberculosis, including posthumously, at his place of identification in each health
institution, regardless of departmental affiliation, the doctor filled
Account Form № 089 / W. The diagnosis of tuberculosis is established only by a physicianTB doctors, as evidenced by the decision TSVKK. Notification to identified
the patient in 3 days (72 hours) is sent to the territorial authority
Management GSEN. A duplicate of the notice sent to the TB
institution of the place of residence the patient.
In patients with established allocation of the Office, except f.089 / Y prepared
"Emergency Notice" (f.058 / V), which is within 24 hours sent to
district (city) center of state (GSEN) and TB
establishment of residence of residence and work sick.
Notification of f.058 / Y filled in the event of death from tuberculosis patients who did not
held during the life of registered TB Dispensary (hospital). For those
no permanent place of residence and registration, notification is
TB dispensary (SSC) at the detection of the disease. In large
cities for more rapid and comprehensive of the anti
activities in the foci of tuberculosis register of patients with active tuberculosis
information to the extent f.058 / V within 24 hours can be transmitted by telephone
department of accounting and registration of infectious patients disinfection stations
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subsequent transfer of emergency information in the PDD and territorial GSEN post
residence, work and study patient.
In the district (city) center GSEN all information received under the form № 089 / U
and the form 058 / U is included in the "Register of infectious diseases" (f. № 60-y),
houses a card index file of organizations.
If you have a focus group of diseases or deaths from tuberculosis
(2 cases or more) and PDD GSEN inform the parent institution.
To accommodate groups of patients with established allocation Office and with the collapse
lung tissue in GSEN annually as of January 1, clarifies the information about
patients remaining from previous years and new patients. In order to harmonize treatment GSEN
perform monthly reconciliations with PDD information about newly registered and taken
with registration of patients, other data are specified, 2 times a year.
In accordance with the requirements of statistical reporting forms 2 "Information
Infectious and parasitic diseases, district and city PDD monthly to
2-th of the month following the reporting reported to the district and city GSEN information about
All identified primary patients with active tuberculosis.
In the PDD and GSEN than a previous medical records for allocating
MBT patients, each center was filled with tuberculosis "Map of epidemiological
survey and monitor a hotbed of tuberculosis.
11.4.6 Sanitary control measures
In order to prevent new infections and diseases in the Office environment
patients in foci of tuberculosis, the following health and disease control
Activities:
1. isolation and treatment of the patient
2. Survey contacts
3. control over the conduct of out-patient treatment and quality
chemoprophylaxis for children and adolescents
4. educational work
Contact persons must undergo a comprehensive survey
antituberculosis organizations in the registration chamber and then periodically 2
times a year. The terms of contact persons should be determined by a physician-epidemiologist. By
number of contacts at work (study) should treat workers, employees and
students are surrounded by a patient with active tuberculosis
bacteriologically. All contacts should be screened
TB organization at work (study);
The observation period of contact of the entire period of contact and 1 year after
effectiveness of chemotherapy. Contact persons from the foci of death
observed for 1 year.
Isolation contact children for rehabilitation should be carried out
spa kindergartens, kindergartens, boarding schools, motels.
One of the important components in reducing the risk source of infection for
surrounding an educational work, both among patients and among
relatives of the patient. From the moment of diagnosis the patient and his family
should receive basic information available to them in the form of that
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such as tuberculosis, he extends that TB is curable. Necessary
reported on a course of treatment and explain the need for medication under
direct supervision.
The patient and his relatives must be persuaded that, if done right treatment
and comply with treatment, TB can be cured. The health worker should
explained that the treatment under the direct supervision required for all
patients. If the patient plans to move, he must notify the
paramedics so that he could take steps to continue treatment at the new
place. The health worker must contact the phthisiatrician the institution where the patient
moved in order to ensure the continuation of treatment and to obtain information
the outcome of treatment.
The patient and his relatives should be explained that TB could become infected
any, of the importance of the survey contact. Especially important to explore children
under 5 years, since they may develop a particularly severe form of tuberculosis.
People from the focus of tuberculosis infection should be able to suspect TB in patients
of contact.
Should explain that the patient, taking all the prescribed medications and
healing from tuberculosis, thereby preventing the disease in their relatives
colleagues and neighbors. In addition, the patient should cover mouth and nose, to turn away in
side when coughing or sneezing; well ventilated area.
I must warn, that soon after the start of treatment the patient feels
better, but it is very important to continue taking medication. The patient and his
relatives should understand that improvement does not mean
recovery. The health worker is obliged to explain that when a break in treatment may
develop multidrug resistance, which
virtually incurable.
In a complex and long-term treatment, as in the case of TB, patients are often not
take any medication. This behavior is one of the largest
problems in TB control and could lead to very serious consequences. Realizing
reasons for poor compliance, health care worker can provide each patient
individual.
Educational work - an ongoing process. After the first visit
hearth, and then in subsequent health care worker must return to such work
during each interview, where in addition to the above should discuss the type and
color assigned to drugs, the number and frequency of taking pills, possible
side effects of TAP.
11.4.7 Actions at the focus of tuberculosis
11.4.7.1 Initial evaluation and implementation of primary measures
In the place of residence of the patient
The primary focus of visiting the place of residence of the patient carried the precinct
psychiatrists and epidemiologists not later than 3 days from the date of its registration. This
specify the place of residence, occupation of the patient, the possibility of his residence on
other locations, contact identified by the family apartment, with other relatives
and individuals.
blood tests, urine tests, Mantoux test 2, the, on the evidence - a study of sputum for Office
and inspection phthisiatrician. The contact persons who have from the time the previous
survey has been more than 6 months, x-ray examination and
tuberculin tests carried out on a mandatory basis.
Principles of survey centers, organization and conduct of epidemiological
activities in higher and secondary special educational institutions are no different from
those in the workplace. However, while taking into account profile institutions
organization of educational process, epidemic risk source of infection and
degree of communication contact with individuals (course, group, flow, cycle). In training
teaching institutions, medical and other profile solves the problem
supervised practice and other matters of educational process.
In children and Related Institutions
Employees of educational, therapeutic and preventive, health, and health
spa, sports facilities and social service institutions for
Children and teenagers are subject to an annual differential fluorographic
examinations for early detection of tuberculosis, in accordance with statutory
Acts of tuberculosis in the Republic of Kazakhstan.
Epidemiological surveys conducted in each case, the registration of patients
with active tuberculosis. His conduct and TB epidemiologist with
health workers serving the institution and its leader.
If you want to attract a physician of the sanitary
unit GSEN. At the same time reconcile their payroll working with the report card on
Salary, payroll of children and adolescents, check the date and result
fluorographic examinations for the previous and current year. During
surveys define the boundaries of the fire, develop an action plan.
Information on all contact persons transferred to the clinic and PDD post
residence to bring them to the survey. This work is particularly well
carried out in maternity wards, offices for premature and weakened children, and
in children's homes.
In establishing the diagnosis of active TB in patients undergoing
treatment of somatic and neuropsychiatric hospitals, primary complex
epidemiological measures implementing the personnel of these institutions.
Not later than 3 days, psychiatrists and epidemiologists conduct in-depth
epidemiological survey.
The list of activities includes:
• registration of the patient in the regional PDD and GSEN
• transfer the patient to TB hospital (persons
neuropsychiatric institutions in case of tuberculosis
transferred to a specialized hospital or department for patients
Tuberculosis with mental health problems)
• the appointment and disinfection at the source
• identifying the contact person for the primary survey
monitor them and send in the future all the contact details on
their main place of residence.
In hospitals with long stay patients in the event of 2 or more
linked cases of tuberculosis requires the commission a survey and
development of measures to ensure containment and recovery focus.
In areas with low population density (rural,
remote villages)
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Foci of tuberculosis that are located in areas with low density
population, have their own specific features, which are counted
examination centers and their rehabilitation. In modern social conditions
require priority attention delimitation hearth. Small
village, numbering up to 400-500 people, with a single social and
municipal structure, where one or more of patients
tuberculosis per 100 inhabitants, may be a single township (rural)
hearth. In these circumstances, patients are closely interact in everyday life with others
its residents, including children.
In the villages located at a considerable distance from other communities
points (hundreds or thousands of kilometers), due to irregular transport links,
become isolated in the appearance of even a single smear,
contacts are formed very high density. In the number of contact here includes all
the villagers, sometimes more than a thousand people.
If you find in the village (or a larger area) smear
psychiatrists and epidemiologists GSEN conducting epidemiological survey. Among
contact persons are not only members of the family of the patient, but also residents of the village or
another territorial unit. Along with filling in cards
epidemiological survey section epidemiological survey
is mapping. On-map of the village with the order numbering
Houses celebrate with family living in their sputum, indicate the date
diseases, noted in regular contact patient (in the form of lines connecting
apartments and / or at home). For information on contact points set by
employees of the local administration, paramedics and the patients and their families.
Based on the received card-schemes define and verify the list of persons
belonging to different categories of contact. In large towns
or in settlements with isolated sputum door-to-door list
contacts may be made without mapping.
All work carried out with strict observance of the requirements of medical ethics, sparing
psyche of the patient, his family and other residents.
In foci of Zoonotic tuberculosis
In foci of tuberculosis Zoonotic infections are a source of origin
sick animals that secrete the Office of milk, faeces and other
secretions. Diagnosis of tuberculosis in animals put on the basis of complex
diagnostic method - analysis of epizootic data, clinical signs and
results of allergic (tuberculin tests), serological (RSK with
tuberculosis antigen), postmortem, histological,
bacteriological and biological research. All cases diagnosed
TB in animals GSEN receives confirmation of the Veterinary Service.
Conducting anti-epidemic measures in the foci of zoonotic origin
carried out in accordance with approved safety regulations.
11.4.7.2 Dynamic observation of foci
The volume of activities in the source and the frequency of his patronage during dynamic
depends on the degree of epidemiological risk.
Before reconnecting the patronage of the focus on medical instruments Dispensary
reviewed developments since the primary focus of the survey
(The nature of bacteria in the patient and the diagnosis of tuberculosis, the results
Survey of contact). The fire specify the composition of contact and their health,
implementation of disinfection and hygiene rules sick
and his relatives.
15. Interagency cooperation in
TB programs
15.1 Basic principles of detection, diagnosis, treatment and prevention
tuberculosis at the organizational level PHC network
When implementing complex TB control activities, mainly
document - "State program of reforming and development
Health of RK for 2005-2010 "identifies the need ubiquitous and
wide transition to the diagnosis and treatment of various diseases in
outpatient basis with the involvement of PHC network.
On this basis, the bulk of TB control activities should
carried out in conjunction with the territorial agencies of public
Health (FAP, SUB SMA, clinics, hospitals). These rules
apply to the organization of medical insurance, family and
private doctors and paramedics, the various departments and
industrial health centers.
On the professional organizations of the network responsible for the fulfillment of PHC activities
three main areas:
1. Timely detection of tuberculosis, based on the quality
sputum microscopy and x-rays
2. Working directly observed (supervised) chemotherapy
TB on an outpatient stage of treatment and chemoprophylaxis.
3. Conducting a large-scale health education about
the first signs of tuberculosis and its prevention methods.
15.1.1 Activities to detect TB at PHC facilities
Tuberculosis is an infectious disease transmitted airdroplets, because of all TB cases in more than 85% affected
lungs. Pulmonary tuberculosis in adults in half the cases has an open
(Infectious) form. Therefore, the task of health professionals PHC is
early identification of infectious patients for their treatment and reduction
spread of tuberculosis infection in the environment.
As a rule, absolute majority of patients with symptoms suspicious for
TB (section 4.2 "Clinical signs"), apply to medical facilities
PHC network. And for the early detection of infectious tuberculosis, all these
ill be sure to investigate the sputum microscopic method for
the presence of Mycobacterium tuberculosis. This method is simple, affordable and
effective in identifying TB, its widespread use will
identify the most dangerous in the epidemiological infectious patients and
thus be the first step to protect the public from the spread
tuberculosis.
Sputum for diagnostic purposes should be performed three times for
regulated rules, according to special instructions (see
Appendix). In cases of incorrect diagnosis of sputum may
billed incorrectly, the disease progresses, the patient will continue
spread the infection may be at risk of infection of contact persons.
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To ensure quality sputum in primary health care facilities must
everywhere to teach the responsible medical personnel at all levels and
Profiles collection procedure of pathological material. Clinical laboratory
PHC should be equipped with modern binocular microscopes and
quality reagents.
At detection of Mycobacterium tuberculosis in sputum, the patient should be
sent to the PTO, where he conducted additional laboratory studies
and assigned to appropriate treatment.
When negative results of sputum microscopy, and the intensification of symptoms
suspicious for tuberculosis after a nonspecific antiinflammatory
therapy, the patient should necessarily be sent for consultation
to tuberculotherapist.
In children and adolescents, as a rule, no humidity, therefore the presence
the above symptoms, they should be sent to ftiziopediatru.
With extra-pulmonary forms of tuberculosis may be affected various organs:
lymph nodes, lining of the brain, bones, joints, genito-urinary organs,
intestine, and others. In difficult diagnostic cases, and in the presence
long standing fistulas of different localizations, the patient should
send to a TB specialist in the field. Along with this, at the opening
or removal of peripheral lymph nodes, fistula of unknown etiology
their contents (pus, mucus, detritus, etc.) should be investigated
microscopic method for the presence of the Office.
Clinical analysis of advanced cases of tuberculosis should be
together with government bodies for sanitary and epidemiological service
VET and PHC, with compulsory execution of protocol parsing and plan
activities.
Teaching assistants, paramedics, doctors, PHC network of antiinterventions should be based on the PTO and completed the issuance
certificate. This prerequisite is
subsequent certification of trained health workers for development
their methods of the Strategy at least 1 times a year.
15.1.2 Treatment of tuberculosis patients at the PHC organizations
The principle of directly supervised treatment of tuberculosis should be
strictly ensured throughout chemotherapy. As is known, in the organization
treat the main condition is to create convenience for the patient. So
receiving anti-TB drugs in outpatients referred to the
primary health care facilities, as the most approximate to the population. This cost-effective to
clinical and economic positions (reduced transport costs,
stop social exclusion, domestic problems are positively solved). C
On the other hand, in this period, virtually all TB patients have
symptoms and most do not want to be in hospitals.
Uncontrolled withdrawal from the hospital is fraught with breaks in treatment, so
much better to conduct a controlled outpatient treatment.
185
For treatment in primary care are sent to TB patients do not pose
epidemiological risk, usually located in the maintenance phase.
In rare cases, outpatient treatment may be prescribed to patients in
intensive phase in the absence of the ILO in the sputum.
In each primary health care facilities where TB patients are treated, should be allocated
place (room) to receive anti-TB drugs and appointed
medical officer responsible for NKL (usually a nurse, so
called "himizator). The medical officer should be trained
Implementation procedures NKL, Records and interpersonal skills
communication. Patients receiving outpatient treatment, should take
Antibacterial drugs under the supervision himizatora every day or
according to the prescribed treatment regimen. Practitioner must
hold weekly clinical examination the patient. When side
TAP reactions or signs of acute illness, the patient should be
directed to consult a TB specialist.
In primary health care facilities should be adequate supply (not less than six months)
TB drugs, depending on the number of patients. Report
movement of drugs should be given to the territorial
TB hospital monthly.
Quality treatment maintenance phase prevents the development
multiresistance Office and preventing relapse.
15.1.3 Health education on TB at the network level
PHC
The success of TB control is largely dependent on the volume and the
quality of the health education (ORS) in the population.
AB is one of the methods for early detection,
prevent and reduce the risk of tuberculosis. In its
implementation should use all available methods in specific circumstances
and means, focusing on building knowledge of the population and patients
about early signs of tuberculosis, the need for appropriate examination and
proper treatment, foster care and hygiene practices.
It should organize awareness campaigns, methods of "interpretation" and
"Printed" word on the regional level, district, any locality where
is the establishment of a network of PHC. You must have an action plan for each
quarter and the corresponding reports on their implementation.
By "oral" methods AB are: interviews, lectures, seminars, public
speech. Effective presentations on local television with the creation of
special game trailers, commercials and documentaries. Speeches
the radio should be interesting with the release of "live" to close
contact with the audience. Statements should be no less than 1 time in
quarter.
186
Promoting healthy lifestyles should be carried out in childhood. In schools
educational centers, it is desirable to hold on a competitive basis to write
works devoted to the identification, treatment and prevention of tuberculosis.
"Printed" methods include the AB publication of articles in local newspapers,
leaflets, posters, leaflets, brochures, sanitary
newsletters, wall newspapers. The place of distribution facilities may be therapeutic
prevention agencies, clinics, pharmacies and libraries. Posters
need to hang out at all enterprises, shops, training centers,
public transport facilities, markets, shops, schools, kindergartens, ie places
the largest concentrations of population. The presence of posters and other visual
materials must be controlled and updated monthly.
ORS should be meaningful, competent, easy to understand.
The content of speeches all the time to be updated.
Evaluation of quality and volume of ORS is carried out in monitoring
Precinct psychiatrists and other specialists on the following indicators:
1. Results of the anonymous survey of patients and 10-15 people (prospectively,
For example, query on the streets in a row every fifth passer). Interview
should identify the level of knowledge of patients and the public about tuberculosis (ways
transmission, risk factors, the main symptoms, ways
diagnosis, treatment, and prevention).
2. The number of posters, leaflets, pamphlets on tuberculosis in public places
(Schools, clinics, shops, transport, etc.)
3. Availability of lectures, pamphlets, essays in the network of PHC workers.
15.2 The roles of sanitary-epidemiological surveillance
Tuberculosis
This section describes the actions of government agencies sanitary
epidemiological services for tuberculosis.
15.2.1 The authorities sanitary and epidemiological service
exercise:
1. coordination of TB control at the regional, urban and
district levels
2. inter-sectoral coordination and interaction with public
organizations to implement national, sector and regional
programs to combat tuberculosis
3. monitoring of epidemiological indicators of tuberculosis among the population
(Morbidity, mortality), accounting and statistics
4. interaction with other government agencies and organizations
tuberculosis control
5. organizing and monitoring of disinfection
6. organizing and conducting seminars, conferences, training sessions on
surveillance of tuberculosis
187
7. administrative measures to the heads of TB and
treatment and prevention organizations in case of violation of the requirements
normative legal acts
8. State purchase of BCG vaccine and tuberculin
15.2.2 The authorities sanitary and epidemiological service
hold:
1. accounting for the first time identified in the reporting year, TB patients on the basis
Notification form 089 / U and smear on the basis of emergency
notification of infectious disease - form 058 / U
2. systematic epidemiological analysis of statistical indicators
characterizing the spread of tuberculosis among the population, as well as the volume
and the effectiveness of interventions on the basis of automated
management system "Surveillance of Tuberculosis and
National Register of TB patients
3. together with experts and TB treatment
prevention organizations, training of health workers to work with
BCG and tuberculin, conduct preventive vaccination
against tuberculosis and tuberculin, followed by
appraisal once a year
4. together with phthisiatric service, network of primary health
Assistance (hereinafter - PHC) and the Center for the problems of forming a healthy way
life of health and social awareness of the measures
tuberculosis prevention
5. monthly reconciliation of accounting tuberculosis patients in the National Register and
TB organizations
6. quarterly monitoring of the situation according to the program
automated control system (hereinafter - ACS) 'Epidemiological
supervision of tuberculosis "
7. monthly monitoring of the use of BCG vaccine, tuberculin, and
well as adverse reactions to the vaccine, epidemiological
investigate the causes of adverse reactions
8. quarterly epidemiological analysis of statistical indicators
characterizing the spread of tuberculosis among the population, as well as the volume
and effectiveness of TB control activities
9. together with the veterinary, TB services and the network of PHC
anti-epidemic and preventive measures in the farms where
detected TB patients are people or animals to identify sources
infection, transmission routes and factors
15.2.3 The authorities sanitary and epidemiological service
monitor:
1. Organization of detection of tuberculosis by microscopy for the presence of
Mycobacterium tuberculosis among persons with clinical symptoms,
x-rays and tuberculin skin test among decreed contingents
2. detection and treatment of tuberculosis, as well as activities undertaken
TB organizations (hereinafter - PTI) and a network of PHC
188
3. separate hospitalization of tuberculosis patients by type, infection
status and the presence of multidrug resistance
4. organization and conduct of sanitary-epidemiological
(Preventive) measures to prevent tuberculosis among
population
5. compliance with anti-epidemic, sanitation and hygiene regimes
TB and the treatment and prevention organizations,
bacteriology laboratories to perform research on tuberculosis
6. organization and completeness of vaccination coverage and revaccination against
tuberculosis of children; terms of transportation, storage, techniques for
and accounting of BCG vaccine and tuberculin
7. activities carried out by anti-organizations and networks
PHC for organizing quality assurance and quality control laboratory
and radiological diagnosis, timely survey of contact
persons in the foci of tuberculosis
8. compliance with anti-epidemic in parts of VET
9. compliance with the requirements of sanitary-epidemiological rules and norms
livestock farms, organizations, products processing
Livestock
10. organization and conduct of sanitary-epidemiological
(Preventive) measures in the foci of tuberculosis
15.3 Tuberculosis control in prisons
The section is intended for specialists on tuberculosis of the civil sector
health, medical and prison officials to
medical employees of the Ministry of Defence, Ministry of
Interior and other departments.
The purpose of the section - to give advice to organizations and agencies that perform
TB in the penal enforcement
systems (MIS), and working with TB, a contingent from the MLS.
15.3.1 Goals and objectives of interagency cooperation
• Inter-departmental collaboration TB services
aimed at efficient use of resources and objective assessment
TB burden in the country. It is essential that antiservices of the penitentiary system were integrated at the national
and administrative levels of the penitentiary system and civil
sector.
• Interaction between the civilian and prison services
aimed at ensuring the quality of each patient
TB from the time of detection to complete a full course of treatment
After his arrest, transfer within the system or release. It involves
equitable access to TB care for all
TB patients, regardless of their location, as well as
continuity of care within the system and after release.
• Interagency cooperation in the control program
Tuberculosis is aimed at:
189
� improve TB control activities in
penitentiary
� reducing cases of "incomplete treatment" among patients
tuberculosis from prison
� prevent the further spread of infection and
development of drug-resistant forms of the disease.
15.3.2 Organization of the prison system and
the Interior Ministry of Kazakhstan
15.3.2.1 Medical Service Ministry of Internal Affairs of Kazakhstan is represented at the national level
Medical management at the regional level - Medical Department DIA.
15.3.2.2 Medical Service of the correctional system in Kazakhstan
presented at the national level by the Office of Medical Support
Committee MIS (EMA CIPO) at the regional level - the Department of Medical
Management Committee of MIS (OMO UKUIS, GMO UKUIS) and at the level
institutions - health units (Medical Unit). Structure
country's prison system includes several levels: effect
isolators, non-specialized institutions (prison) and specialized
institutions for treatment and detention of tuberculosis patients. In these
structures, a specialist, responsible for antiactivities.
Pre-trial detention - a penal institution for the detention of persons
under arrest before the court verdict into force. The time spent in
remand depends on the type and severity of the crime
acts, and the average duration is 5-6 months, sometimes this period may
up to 2 years or more.
Medical care of the investigative and arrested at this stage have
Specialists Medical Unit. Diagnostic measures for identifying TB conducted
within the institution, including a diagnostic algorithm,
fluorographic study, microscopic examination at the Office. In
If there is no region of the hospital / institution for the maintenance and
TB patients, or their remoteness, TB Service
civilian health sector at this stage involved in conducting
TSVKK.
The functions of the Medical Unit include the identification and diagnosis of TB cases, isolation on the
basis
MBT, registration, commencement of treatment (completion of treatment),
escorting, selection and examination of contact persons, conducting related
medical documentation, reporting and analysis of the effectiveness
TB control activities.
Patients receiving chemotherapy, after the verdict in
force is transferred to the TB facilities MIS.
190
Non-specialized correctional institution (colony) is a penal institution
for individuals after the court verdict into force. In the Medical Unit
colonies carried the identification of persons with suspected TB patients in isolation
the basis of bacteria, keeping concomitant medical records
reporting and analysis of the effectiveness of TB control activities, selection and
examination of contact persons.
Convicted on admission to the colony for 14 days contained in
quarantine, which conducts diagnostic measures to detect TB
and other diseases. After the quarantine convicted determined in residential
facilities (units).
Initial diagnostic measures (screening for smear microscopy and
etc.) to identify TB specialists conducting clinical institutions.
Civilian health sector at this stage of the program involved to
agreed to conduct the planned fluorographic study
(Mobile unit), microscopic and bacteriological examination
material at the Office. In the absence of TB in the region
hospitals / institutions for the detention and treatment of TB patients or their
remoteness, the civilian TB service health sector
at this stage involved in conducting TSVKK to confirm the diagnosis.
Detection of TB patients in the colony, are referred to
TB facilities MIS
Tuberculosis hospitals and institutions MIS designed for content and
outpatient treatment of TB patients. According to the orders of Chairman of the Committee MIS
from July 1, 2005 № 95 "On Approval of Instruction for Epidemiological
tracking of people suffering from tuberculosis and record-keeping and reporting documentation
the criminal-executive system "there are 2 types of lines
TB patients to inpatient treatment:
1 species - TB patients sent to the TB
correctional facility within its area
2 shows - tuberculosis, aimed at TB
correctional institution of another
In order CIPO MJ RK on August 2, 2004 № 154. On assignment to the treatment
prophylactic institutions of the correctional system, "stated
details of admission of TB patients.
Medical care is convicted at this stage are provided by specialists
hospital and dispensary (outpatient) facilities. Diagnostic events
identification of TB, including sputum for TB, X-ray
study, a course of non-specific therapy, if necessary,
Definitive diagnosis in TSVKK, coordinated TB doctors
outpatients.
Anti-tuberculosis activities in them - diagnosis of TB cases,
holding TSVKK, isolation of patients on the basis of bacteria,
centralized registration, management of concomitant medical
documentation, entering patients in the National Register of TB patients,
reporting and analysis of the effectiveness of TB programs.
Patient registration, appointment of therapy and monitoring treatment
by TB doctors hospital. In the case of complex diagnostic
cases involved TSVKK civilian health sector.
15.3.3 Organisational structure of interagency cooperation in
TB Program provided on 3 levels:
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• National level - The Government of Kazakhstan, Ministry of Health of Kazakhstan, Ministry of Health
NTSPT RK, KSEN
Ministry of Health, Ministry of Justice of Kazakhstan, UMO CIPO MJ RK, Ministry of Internal Affairs of
Kazakhstan, ME Kazakh Interior Ministry, the Office and the NW
RK
• Regional level - Regional governorates, CLE, OPTD, SES, UKUIS, DVD,
DT and NW
• District level - District governorates, CLE, RTD (RTB), SES, DVDs, DT and NW.
In order to ensure continuity of treatment at each level of a system of accounting
the number in custody was received and released from prison
system.
Planning for integrated services performed by the coordination and
referring the parties to participate under the guidance of NTSPT.
15.3.3.1 Tuberculosis civil service health sector.
In accordance with instructions from the Ministry of Health of Kazakhstan April 23, 2007 № 245
TB service of the civil sector has the following functions
on interagency cooperation:
At the national level:
• provision of advice, organizational and methodological assistance
medical organizations and the general medical service departments MJ RK
ROK Defense, the Interior Ministry of Kazakhstan;
• Organizing and conducting trainings, seminars, conferences
Professional phthisiatric service sector and the civil agencies
MoJ, MoD, MVD;
At the provincial and district levels:
• provision of organizational and methodological leadership PTO, medical
organizations of primary care agencies and organizations, MJ, MO, MoI
TB;
The duties of the coordinators of interagency cooperation
civilian health sector include:
1. Organization and coordination of interagency cooperation in the program
TB control at country / region / district
2. Organization of monitoring the effectiveness of interagency
interactions on selected indicators at the level
country / region / district
3. Definition of needs and provision of training specialists TB services
issues of interagency cooperation in the program control TB
4. Participation in the training of specialists TB service of inter
interaction
5. Organization and participation in the annual national intermeetings and conferences on tuberculosis, quarterly coordination
Boards
15.3.3.2 prison system
In accordance with the joint order of Ministry of Health of RK № 405 and № 145 MJ Kazakhstan dated
December
2004. Medical office MIS has the following functions
interagency cooperation:
The duties of the coordinators of interagency cooperation MIS include:
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1. Organization and coordination of interagency cooperation in the program
control of TB at the prison system
country / region / institution
2. Organization of monitoring the effectiveness of interagency
interactions on selected indicators at the level of the penitentiary
system of the country / region / institution
3. Definition of needs and provision of training specialists TB services
penitentiary system of interaction in the control program
on TB
4. Participation in the training of specialists TB services of the penitentiary system
of interagency cooperation
5. Participation in the annual national inter-agency meetings and
conferences on tuberculosis, the organization's quarterly
coordinating councils
15.3.3.3 The Ministry of Internal Affairs of the Republic of Kazakhstan
In accordance with the Regulation № 406 of December 2004. Medical Service Ministry of Internal Affairs
performs the following functions for interagency cooperation.
The duties of the coordinators of interagency cooperation MIA include:
1. Organization and coordination of interagency cooperation in the program
TB control at the level of departmental health
country / region / district
2. Organization of monitoring the effectiveness of interagency
interactions on selected indicators at the level of departmental
Health
3. Analysis of the data on interagency cooperation
4. Definition of needs, and training for professionals
departmental health issues of cooperation in the program
TB control
5. Participation in the annual, national, interagency meetings and
conferences on tuberculosis, the organization's quarterly
coordinating councils.
15.3.3.4 The Ministry of Defence of the Republic of Kazakhstan
In Defense of Kazakhstan / / provincial military enlistment offices / Rayon military enlistment offices are
determined
coordinators of interagency cooperation. Tasks are defined
as:
1. Coordination of interagency cooperation in the program
TB control at the level of departmental health
2. Organization of monitoring the effectiveness of interagency
interactions on selected indicators at the level of departmental
Health
3. Analysis of data on interagency cooperation
4. Definition of needs, and training specialists
Health departmental liaison officers in the program
TB control
5. Participation in the annual, national, interagency meetings and
conferences on tuberculosis, the organization's quarterly
coordinating councils.
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15.3.3.5 Sanitary-Epidemiological Service
In accordance with the following functions UGSEN described in order MH RK
on July 27, 2007 № 452, SES provides:
1. Coordinating the fight against tuberculosis at the regional,
city and district levels
2. Inter-sectoral coordination and collaboration with public
organizations to implement national, sector and regional
programs to combat tuberculosis
3. Interaction with other government agencies and organizations in
tuberculosis control
4. Organization and conduct of sanitary-epidemiological
(Preventive) measures to prevent tuberculosis among
population
The duties of the coordinators of interagency cooperation MIA include:
1. Organisation monitoring the effectiveness of interagency
interactions on selected indicators at the level
country / region / district
2. Analysis of data on interagency cooperation at the level of
country / region / district
3. Participation in the training of interagency cooperation
4. Participation in the annual, national, interagency meetings and
conferences on tuberculosis, the organization's quarterly
coordinating councils
15.3.4. Description of TB control activities for interagency
Interaction
15.3.4.1 Detection and diagnosis of tuberculosis
Identification of cases of tuberculosis in the penitentiary system
carried out by two methods:
• Active identification (during routine inspections, routine
fluorographic examination)
• Passive detection (when referring to a doctor)
To detect cases of tuberculosis at the detention center used only passive
identification, ie, a patient receiving a complaint seeking medical
by the assistant. The latter makes a request to the territorial civil
institution for a diagnostic algorithm for tuberculosis. Further
organized visits the patient in the TB dispensary or
territorial institution of PHC.
Identification of tuberculosis cases within the prison system is carried out,
mainly in the peripheral facilities and pre-to
following stages:
• when entering the facility during the time spent in quarantine
• during their stay in the facility during a preventive health
examinations, as well as in the case of seeking medical help at the
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disease
In order to identify persons with suspected tuberculosis fluorographic
survey is all new arrivals at the prison
if the term of the last survey than 3 months, and in
Subsequently, every 6 months.
Medical professionals institution hold weekly round
for orders with a view to identifying persons with complaints of feeling unwell and sick,
who do not go to the doctor yourself.
Persons suspected of having tuberculosis (changes in the fluorogram, symptoms,
complaints) conducted microscopic examination of sputum smears. If
negative result of sputum, the patient being diagnostic
algorithm.
Diagnosis of tuberculosis confirmed TSVKK MIS. To remand
diagnosis is confirmed by TSVKK regional TB
dispensary in the absence of TB facilities MIS or
remoteness.
In the absence or malfunction fluorographic apparatus in penal institutions in
during routine x-rays TB service of civil sector
technical assistance (mobile x-ray machine).
In the absence of opportunities in the penal institutions (lack
microscopic laboratory, lack of laboratory), the territorial
antituberculosis institutions of civil society spend microscopy
sputum smears for the prison system agreed.
In order to ensure the quality of diagnosis of tuberculosis in the penitentiary system,
diagnosis is confirmed TSVKK. The diagnosis of tuberculosis for institutions MIS
confirmed the territorial TSVKK civil sector in the following
cases:
• in the penal system of no
TB facilities for maintenance and outpatient
prisoners with tuberculosis
• The establishment of the penal system is located on a large
distance from tuberculosis institutions MIS, based on which
There TSVKK
• there are complex with a diagnostic point of view of cases
15.3.4.2 Laboratory Service
MIS has its own laboratory services, which is represented
laboratories I and II. Typically, laboratories are located at Level I
the basis of the detention facility, the peripheral and TB facilities. Depending
opportunities and conditions, laboratory level I organized either
the basis of each institution, or on the basis of only antituberculous institutions
(Eg, in the Pavlodar region).
In the laboratories of Tier I conducted microscopic examination of sputum smears
diagnostic (in the peripheral facilities, remand) and monitoring of treatment
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patients (based on TB facilities and jail). Lab I level
organized on the basis of TB control agencies
quality of research conducted by laboratories in the peripheral colonies,
Remand.
Lab II levels are based TB dispensaries and
conduct all the research laboratories of Level I, bacteriological
studies, identification of drug resistance, training and
Quality Control Laboratory I level. Exception
is UKUIS in Karaganda region, which has its own
Laboratory II level on the basis of the hospital.
Bacteriological studies and determination of drug resistance
for MIS, with the exception of the Karaganda region, spend
bacteriological laboratories TB dispensaries, according
agreement.
Quality microscopic studies conducted by specialists
civilian health sector.
Report on the results of quality control laboratory and MIS
Recommendations are sent to the county / city coordinator for the laboratory
civilian TB services in NTSPT RK and territorial
medical service MIS.
Provincial and regional TB dispensaries civil
the health sector, in the absence of bacteriological laboratories and
seed points in the penal institutions, carry out cultural studies and
definition of drug sensitivity in agreement.
15.3.4.3 treatment, monitoring treatment and treatment after release
When detected TB cases during stay in IVS software
anti-TB drugs being territorial
anti-establishment civilian health sector.
NKL holds paramedic facility.
Treatment of TB patients in prisons held in jail, TB
hospitals and special institutions for the maintenance and outpatient
prisoners with tuberculosis. Convicted women and adolescents, ex
employees of agencies and courts, persons sentenced to life imprisonment
freedom and detainees held in prison get TB treatment
post detection.
In tuberculosis hospitals and institutions for the maintenance and outpatient