A clinical trial of combined use of
Pien Tze Huang and TACE
in the treatment of primary liver
cancer
Shui-lian ZHAO
Jie PIAN
Zhangzhou Pien Tze Huang Pharmaceutical Co.Ltd.Zhangzhou Fujian 363000,China
*E-mail:pzhzsl@126.com
Abstract:Objectives: We aimed to investigate the therapeutic effect of combined usage of Pien
Tze Huang (PTH) on the treatment of primary liver cancer. Method: This Phase II randomized,
double-blind, placebo-controlled clinical trial enrolled 240 patients with primary liver cancer.
Patients were randomized to receive either TACE and PTH or TACE and placebo. PTH group was
prescribed to 2 pills (for 3 times a day), for 2 cycles of 4 weeks. 102 cases in PTH group and
105 cases in placebo group were used for statistical analyses. The enhancing effect of PTH on
anti-tumorigenesis was assessed. Results: A statistically greater proportion of the PTH group than
the placebo group had improvements in tumor size shrinkage, quality of life, pain relief and
therapeutic effect. Moreover, the side effects induced by chemotherapy such as lowering of
leukocytes levels, vomiting, increased ALT, AST enzyme were improved in the PTH
group.Conclusion: The combined usage of Pien Tze Huang and TACE improve the therapeutic
effect on the treatment of primary liver cancer.
Key words: Pien Tze Huang capsule primary carcinoma of the liver TACE clinical
Notice: PZH group=TACE+PZH , Control=TACE+placebo,Before=Before the treatment
After=After the treatment
Results:
1、The general efficacy:
The response rate of the PZH group was 85.3%.
The response rate of the control group was 59.0%.
100
90
80
70
60
50
40
30
20
10
0
PZH
group
Control
the efficacy
2、Chinese medicine symptom total integral
10
9
8
7
6
5
4
3
2
1
0
PZH group
Control
before the
treatment
after the
treatment
After the treatment ,the improvement of chinese medicine symptom in the PZH group was better
than that in the control group.
3、The quality of life
100
95
90
85
80
75
70
65
60
55
50
PZH group
control
Before the treatment After the treatment
After the treatment ,the quality of life was significantly increased in the PZH group.
4、After the treatment ,tumor size was significantly decreased
CM2
35
30
25
PZH group
Control
20
15
10
5
Before
After
Before-After
After the treatment,tumer size in the PZH group was decreased signaler than that in the
control group, tumer size shrinkage in the PZH group was 50%.
5、After the treatment,the AFP in serum was decreased
3000
2800
2600
2400
2200
2000
1800
1600
1400
1200
1000
800
600
400
200
0
PZH group
Control
Before
After
After the treatment,the AFP level in serum in the PZH group was declined signaler than that
in the control group.
6、The VAS grade point of pain
VAS评分实测值历时性变化
实验组
对照组
VAS评分
4
3
2
1
0
0
8
15
22
29 36
时间(天)
43
50
57
64
Notice: Red is the control group and blue is the PZH group.
7、The circumstance of pain-killer application:
PZH group
N（%）
Increase
No change
Decrease
Total
2（7.7）
1（3.8）
23（88.5）
26
control
N（%）
7（35）
2（10）
11（55）
20
P值
method
0.011
CMH
8、The variety of step that the medicine was used of treatment
cancer’s pain
.
PZH group
N（%）
Increase
No change
Decrease
Total
1（3.8）
2（7.7）
23（88.5）
26
control
N（%）
6（30）
3（15）
11（55）
20
P值
0.007
method
CMH
9、The improvement of chemotherapeutic vice-reaction and
toxic-action
3
2.7
2.4
2.1
1.8
1.5
1.2
0.9
0.6
0.3
0
PZH group
Control
Before
After
After-Before
10、The ALT changed
U/L 60
55
50
45
PZH group
Control
40
35
30
25
20
Before
After
After the treatment,the ALT of patients in the PZH group were significantly decreased.
11、The AST changed
U/L 60
55
50
45
PZH group
Control
40
35
30
25
20
Before
After
After the treatment,the AST of patients in the PZH group were significantly decreased.
12、The WBC changed
109个/L
8
7
6
PZH group
Control
5
4
3
Before
After
After the treatment,the leukocytes levels of patient in the conrtrol group were decreased signaler
than that in the PZH group.