Use of the Enterosgel in combined therapy of pyelonephritis in children, 2009
http://www.mif-ua.com/archive/article/8638
Bagdasarova I.V., Fomina S.P., Lavrenchuk O.V., Osadchaya O.I., Sheiman B.S., Bagdasarov
R.V.
Institute of Nephrology, Ukraine Academy of medical sciences, Kiev
Categories: Pediatrics / Neonatology
Prevalence of urinary system diseases in Ukraine is 37 per 1000 children and tends towards
constant growth. Among the urinary tract infections pyelonephritis (PN) is the most serious
problem, which occupies a leading place among nephrology pathologies of childhood [3, 4]. In
the recent years, an increase of recurrent and latent disease types is often accompanied by
development of intoxication syndrome, probably caused by agents of toxin production, as well as
by response of the body, with the development of endotoxemia, metabolic and immune distress
[2, 3, 8].
Increasing resistance of infectious agents to antibiotics, in spite of their choices, limits the
effectiveness of PN treatment, while biocenosis violation caused by prolonged therapy, with
development of allergic sensitization and reduced adaptive capacity and complicates the disease
course.
An integrated approach to PN treatment using detoxification methods, in particular enterosorbent
Enterosgel allows to increase the effectiveness of treatment in children. Enterosgel is a sorbent,
which has high selective sorption activity towards medium-weight molecules of toxic substances
and pathogens. Known for its detoxifying properties of the liver and gastrointestinal tract,
kidneys and mitigation of allergic conditions in children, the product can improve the results of
standard therapy [2, 6-8]. It is not transformed and is completely eliminated from the body,
resulting in the safe use and absence of side effects.
The purpose of research is to study clinical effect of Enterosgel in children with pyelonephritis.
Materials and methods
The study was conducted with participation of 60 children aged from 3 to 14 years in the active
stage of acute and chronic primary and secondary PN. The diagnosis was verified on the basis of
traditional clinical and laboratory methods (medical history, assessment of complaints, objective
data, results of laboratory and microbiological examination, ultrasound of the kidneys and
bladder, according to testimony - excretory urography, voiding cystourethrography). Renal
function was assessed in terms of dynamic and static renal scintigraphy. Endotoxemia degree
was determined using standard clinical and laboratory tests (hyperthermia, leukocytosis, ESR
level etc.) as well as objectified indices - leukocyte intoxication index (LII), autologic blood
serum activity (ABSA) [1, 5].
Patients were randomly divided into 2 groups. The study group consisted of 30 people receiving
Enterosgel in addition to standard treatment, the test group – of 30 children receiving only
antibiotic therapy according to the protocol. Standard antibiotic therapy included the use of
antibiotics for 10-14 days in the age-matching dosages (with parenteral administration of drugs
in hyperthermia, intoxication, and step transition to administration per os as symptoms
subsided). The drugs of choice were protected penicillins and cephalosporins of II-III generation.
In septic course of the disease or secondary PN genesis combination therapy used (antibiotics
and uroseptics). Enterosgel was administered 1.5 hours before or after meals for 14 days, the
dose depending on the age of the child (3-5 years - 1 teaspoon (5 g) 3 times a day, older than 5
years – 1 dessertspoon (10 g) 3 times a day).
Treatment efficiency was assessed by the same type of clinical and laboratory parameters on
days 7 and 14 from the beginning of the observation.
The results were processed using variation statistics methods (statistical software package
SigmaPlot 2000) and Fisher's exact test (significance of differences rTMF <0.05), afterwards
they were compared with the laboratory parameters of 10 healthy children.
Table 1. Classification of patients with pyelonephritis considering disease type, age and gender
Pyelonephritis form
Primary
Secondary
Primary
Secondary
<5 years
5-10 years
>10 years
Boys
Girls
Acute
Chronical
Age
Gender
Main group, n (%)
17 [56.7]
3 [10.0]
4 [13.3]
6 [20.0]
12 [40.0]
13 [43.3]
5 [16.7]
6 [20.0]
24 [80.0]
Control group, n
(%)
12 [40.0]
4 [13.3]
8 [26.7]
6 [20.0]
12 [40.0]
16 [53.3]
2 [6.7]
3 [10.0]
27 [90.0]
Table 2. Dynamics of the main values in the study groups (M±m)
Lab
values
Main group, n=30
0
RBC,
1012/ l
Hb, g/l
WBC,
106/ l
ESR,
mm/h
LII
3.90±0.0
6
119.0±4.
30
8.80±0.6
1*
20.00±2.
90*
ABSA,
%
2.20±0.2
5*
64.30±1.
23*
Urea,
mmol/l
4.70±0.3
0
Control group, n=30
Examination day
14
0
Complete blood count
3.80±0.0 3.80±0.07 3.90±0.0
6
6
121.00±2 121.00±2.2 124.00±2
.10
0
.10
6.80±0.4 5.60±0.32* 7.10±0.3
8
8
18.00±2. 11.00±1.50 18.00±2.
50*
80*
Endotoxemia indeces
1.10±0.09* 2.00±0.3
*
3**
42.00±1.04 65.20±1.
***
45
Blood serum study
4.30±0.29 4.40±0.3
2
7
Healthy
children,
n=10
7
14
3.80±0.0
6
123.00±2
.00
6.40±0.3
9
15.00±1.
50*
3.90±0.07
121.00±2.
10
5.30±0.21
**
9.00±1.20
**
4.00±0.0
2
125.00±3
.80
6.20±0.7
1
6.00±1.8
0
-
1.80±0.10
*
69.40±1.3
5*
0.90±0.1
3
20.50±2.
45
4.30±0.32
4.80±0.6
1
-
-
Creatini
ne,
mmol/l
Total
protein,
g/l
ALT,
mmol/l
0.060±0.
004
-
0.060±0.00
4
0.060±0.
003
-
0.070±0.0
05
0.060±0.
005
72.00±1.
40
-
73.00±1.40
69.00±1.
20
-
70.00±1.3
0
70.00±1.
50
0.30±0.0
7
-
0.40±0.11
-
0.20±0.02
0.20±0.0
4
Protein, 0.030±0.
g/l
003
WBC, All HPF*
per HPF
RBC,
2.50±1.0
per HPF
0
0
0.20±0.0
2
Urinalysis
0
0.030±0.
003
2.30±1.20* All HPF*
*
0
3.00±0.5
0
0
0
0
18.20±1.
80*
0
12.30±1.1
0**
0
2.00±0.2
0
0
8.50±1.0
0*
0
Results and discussion
The groups were matched by age, sex structure, PN form and type, as well as its activity (Table.
1).
In both groups girls aged 5 to 10 years dominated. One-third of patients was diagnosed with
secondary PN by urinary system malformations (ureterohydronephrosis, vesicoureteral reflux,
etc.).
An objective examination of the disease manifestations showed acute form in 31 children
accompanied by clinical signs of intoxication: weakness, nausea, high temperature, abdominal
and lower back pain (63.3% of cases in the study group - 17 patients, and 46.7% in the control
group – 14 patients).
In the active PN phase laboratory studies (Table. 2) in all children showed a slight increase in
ESR and moderate leukocytosis, but endotoxemia indices were significantly higher than normal:
LII – twice of three times higher, ABSA - 3-4 times higher.
No changes in the biochemical blood analysis were observed. In five patients partial disorder of
renal functions was recorded (3 patients in the main group, 2 patients in the control group).
Table 3. Frequency and of urine pathogens in the study groups
Microbial
species
Examination day
E.coli
Klebsiella
Ps. aeruginosa
Proteus spp.
Streptococcus
Enterobacter
Not defined
Main group
n (%)
0
25* (83.4)
1 (3.3)
1 (3.3)
1 (3.3)
2* (6.7)
n (%)
14
1 (3.3)
28 (96.7)
Control group
n (%)
0
17* (56.7)
1 (3.3)
1 (3.3)
2 (6.7)
2 (6.7)
7* (23.3)
n (%)
14
1 (3.2)
1 (3.3)
1 (3.3)
27 (90.0)
Note: * - pFT<0.05 in comparison with day 14 of the study.
Urinary sediment was manifested through leukocyturia in all cases: in 85.0% of cases - massive,
15% - 40-60 per HPF (p / HPF).
In microbiological study E. coli with high bacterial count prevailed in the urine culture (Table 3).
Only in seven cases (15.0%) bacteriuria was absent.
The assigned therapy promoted decrease of clinical signs of PN activity in all the patients. By
day 4-5 normal temperature restored, pain, dysuria and intoxication syndrome decreased,
appetite restored in 18 patients of the main group (60.0%) and 10 patients of the control group
(33.3%). By day 7 of the treatment, all patients receiving Enterosgel felt satisfactory in the
control group, in six patients (20.0%) asthenic syndrome persisted. Subjective data corresponded
laboratory data - in the main group normalization of erythrocyte sedimentation rate was earlier,
while leukocytosis decreased (Table. 2). By the end of week 1 of observation leukocyturia
decreased in 17 patients of the main group (56.7%) and 13 patients of the control group (43.3%),
and by day 14 it preserved only in 10 and 20%, respectively, with the secondary PN (3 and 6
patients). On bacteriological examination of urine no microbial growth was identified in the
majority of cases (Table. 3).
Despite the positive dynamics of clinical and laboratory parameters with their normalization in
most cases, intoxication indices remained high on day 14 of treatment (Table. 2). Patients treated
with Enterosgel in the complex therapy showed a significant decrease in the mean values of
these parameters from baseline, although they did not reach those of healthy children. In the
control group there was a downward trend only in LII and ABSA.
In general, high efficiency of treatment (measured by time of normalization of body temperature,
restoration of clinical and laboratory parameters, LII degree, ABSA reduction) was significantly
more frequent in PN patients of the main group. This was due to selective action of enterosorbent
towards toxins with molecules of small and medium size in the blood plasma, which maintains
natural detoxification systems, as shown by previous studies, (toxin-binding property of serum
albumin, functional activity of phagocytic and immune-competent cells) and immune reactivity
at subcompensated level [ 2, 7, 8].
Application of Enterosgel in the treatment of pyelonephritis in children aged 3 to 14 years during
14 days promoting regression of intoxication symptoms and subjective complaints earlier than in
patients receiving only antibacterial and symptomatic therapy. In these patients laboratory signs
of inflammation and endotoxemia decreased significantly (ESR, WBC count in the peripheral
blood, LII, ABSA).
Enterosgel is well tolerated by children and has no side effects, thus it can be recommended for
widespread use in the treatment of microbial and inflammatory diseases, not only renals, but in
other organs and body systems.
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