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Journal of Chinese Integrative Medicine ›› 2003, Vol. 1 ›› Issue (2): 89-98.doi: 10.3736/jcim20030204

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Multicenter clinical study about the action of Fuzheng Huayu Capsule against liver fibrosis with chronic hepatitis B

Ping Liu1, Yi-yang Hu1, Cheng Liu1, Lie-ming Xu1, Cheng-hai Liu1, Ke-wei Sun2, De-chang Hu3, You-kuan Yin3, Xia-qiu Zhou4, Mo-bin Wan5, Xiong Cai6, Zhi-qing Zhang7, Jun Ye8, Bao-zhang Tang9, Jia He10   

  1. 1. Research Institute of Liver Diseases, Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China
    2. Infectious Diseases Department,The Affiliated Hospital of Hunan College of Traditional Chinese Medicine,Changsha,Hunan Province 410007,China
    3. Infectious Diseases Department,Zhongshan Hospital,Fudan University,Shanghai 200032,China
    4. Infectious Diseases Depa rtment , Ruijin Hospital , Shanghai Second Medical Unive rsity , Shanghai 200025 , China
    5. Infectious Diseases Depa r tment , Shanghai Changhai Hospital , Shanghai 200433 , China
    6. Infectious Diseases Depa rtment , Shanghai Changzheng Hospital , Shanghai 200003 , China
    7. Infectious Diseases Depa rtment , T he 4th People’s Hospital of Huai’an City , Huai’an , Jiangsu Province 223300 , China
    8. Infectious Diseases Depar tment , The Cent ral Hospital of Putuo District , Shanghai 200062 , China
    9. Infectious Diseases Depa r tment , T he Affilia ted Hospital of Yunnan College of T raditional Chinese Medicine, Kunming , Yunnan Province 650200 , China
    10. Mathematical Statistics Depar tment , Second Military Medical University , Shanghai 200433 , China
  • Received:2003-05-12 Online:2003-06-20 Published:2018-10-19

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Objective

To study the efficacy and safety of Fuzheng Huayu Capsule (FZHY Capsule) against liver fibrosis with chronic hepatitis B.


Methods

Multicentric, randomized, double blinded and paralleled control led trial was conducted on patients (aged between 18 and 65) with liver fibrosis in chronic hepatitis B．Indexes observed: (1) hepatic histological changes and HBV markers were observed at 0 and 24th week during the treatment; serological indexes (HA, LN, P-Ⅲ-P, Ⅳ-C) were determined and B ultrasound examination of spleen and liver was taken at 0, 12th, 24th week; liver function (during the period of follow-up, liver function and serological indexes for liver fibrosis were evaluated) were observed at 0, 6th, 12th, 18th, 24th week; (2) indexes for safety: blood and urine routine tests, renal function and ECG were examined.


Results

(1) Enrollment and demographic data: There was no significant difference between the trial (110 cases) and control group (106 cases) in demographic feature, vital signs, course of illness,history for drug anaphylaxis, history of previous therapy, liver function, serological indexes for liver fibrosis, liver histological examination (99 cases for test group, 96 cases for control group), HBV markers, and renal function, etc. (2) Histological pathological examination: 93 cases of liver histological examination were taken, of these 50 cases for the trial group and 43 cases for control group which turned out to be at S mean value of 2.33 and 2.11 respectively pretreatment according to criteria for liver fibrosis staging. Post-treatment, the trial showed a significant decrease with S value of 1.80 compared to that of pretreatment; however, there was no significant improvement in control group before and after the treatment with S mean value of 2.14. There was significant difference in reversing rate (decrease at least 1 stage according to criteria for liver fibrosis staging) between the trial (52%) and control (23.3%) after liver biopsy. The trial had a rather good effect on improving inflammatory activity and was superior to control group with a marked decrease of mean value of inflammatory activity and score of inflammation (P<0.05). (3) Serological indexes for liver fibrosis: There was a significant decrease in HA, LN, P-Ⅲ-P, Ⅳ-C content in test group after 12 and 24 weeks' treatment compared to that of pretreatment; the differences of HA, LN, P-Ⅲ-P, Ⅳ-C between 12 , 24 weeks' treatment and pretreatment were significantly greater than control group (P<0.01 or 0.05); the effectual was defined as 2 of 4 indexes lowered more than 30% of the baseline, according to this criteria, the trial was 72.7%, while control group 27.4% (P<0.01). (4) Liver function: Obvious improvement of serum Alb, ALT, AST, GGT was seen in 2 groups; compared with control group, marked improvement of GGT and Alb in the trial (P<0.05); the effective rate of serum ALT in the trial group was 72.7%, while control 59.4%. (5) No changes of significant difference between pre- and post-treatment in routine tests for blood and urine, renal function and ECG, etc. There was also no difference in the stable rate of ALT and serological indexes for liver fibrosis between the trial and control group 12 weeks after withdrawal (P<0.05).


Conclusion

Fuzheng Huayu Capsule has good effect on alleviating liver fibrosis in chronic hepatitis B without any adverse effect and is superior to Heluo Shugan Capsule. Fuzheng Huayu Capsule is a safe and effective medicine for the treatment of liver fibrosis in chronic hepatitis B.

Key words: Fuzheng Huayu Capsule, chronic hepatitis, liver fibrosis, clinical study

CLC Number: 

  • R657.31

"

组别 n 性别（男/女）（例） 年龄（岁）（$\bar{x}$±s） 婚姻（未/已）（例） 体重（kg）（$\bar{x}$±s ） 既往治疗史(例) 伴随用药(例)
试验组 110 95/15 37.7±9.2 21/89 64.30±8.25 11 26
对照组 106 89/17 38.5±8.9 15/91 64.09±6.64 17 26
P 值 0.848 0.512 0.361 0．844 0.155 0.174

"

组别 n 红细胞(1012/L) 血红蛋白(g/L) 白细胞(109/L) 血小板(109/L) BUN(mmol/L) Cr(μmol/L) PT(s)
试验组 110 4.6±0.7 139.8±16.7 5.1±1.4 137.1±86.0 4.4±1.3 84.1±17.4 13.6±1.9
对照组 106 4.5±0.7 138.9±16.5 5.0±1.4 117.8±48.1 4.7±1.6 86.9±21.0 13.5±1.7
P 值 0.499 0.761 0.499 0.054 0.193 0.441 0.168

"

组别 n 炎症(G) 纤维化(S)
1 2 3 4 1 2 3 4 a
试验组 99 12 49 29 9 22 39 21 17
对照组 96 22 39 27 8 33 31 20 12
P 值 0．277 0.121

"

组别 n HbsAg HbsAb HbeAg HbeAb HbcAb HBcAb-IgM HBV-DNA
试验组 110 110 3 48 48 105 40 38
对照组 106 106 2 48 56 100 35 37
P 值 1.000 0.891 0.220 0.765 0.659 1.000

"

组别 n 治疗前（例数） 治疗后（例数） P 值
1 2 3 4 G均数 1 2 3 4 G均数
试验组 50 5 25 15 5 2.40 18 20 11 1 1.90 0.001
对照组 43 10 19 12 2 2.14 11 17 10 5 2.21 0.583
P 值 0.277 0.004

"

组别 n 治疗前（例数） 治疗后（例数） P 值
0 1 2 3 4 S均数 0 1 2 34 4 S均数
试验组 50 0 8 23 10 9 2.40 1 23 14 9 3 1.80 0.001
对照组 43 0 11 20 7 5 2.14 2 8 22 4 7 2.14 1.000
P 值 0.121 0.001

"

组别 n 治 疗 前 治 疗 后 P 值
试验组 37 8.8±3.9 6.6±4.7 0.001
对照组 31 7.3±4.1 7.4±4.1 0.978
P 值 0.185(P1) 0.036(P2)

"

组别 n 治 疗 前 治 疗 后 P值
试验组 37 8.1±5.6 6.0±5.4 0.001
对照组 31 7.2±5.5 8.1±6.3 0.413
P 值 0.433(P1) 0.007(P2)

"

组别 n 显效例（％） 有效例（％） 无效例（％） P值
试验组 50 4（8.0） 22（44.0） 24（48.0） 0.008
对照组 43 1（2.4） 9（20.9） 33（76.7）

"

项目 组别 n 治 疗 前 治疗12周 治疗24周
HA(μg/L) 试验组 110 303.6±235.7 178.9±158.0** 147.9±131.3**
对照组 106 276.3±234.9 258.9±243.2* 261.8±253.6
LN(μg/L) 试验组 110 137.0±84.6 127.5±92.7* 122.4±96.5*
对照组 106 134.1±98.6 128.4±55.7 121.2±48.9
P-Ⅲ-P(μg/L) 试验组 110 11.1±5.0 8.8±4.9** 7.4±4.4**
对照组 106 9.6±5.6 9.7±6.6 9.4±6.9
Ⅳ-C(μg/L) 试验组 110 119.1±132.5 74.5±88.4** 64.5±82.5**
对照组 106 91.8±76.7 71.4±57.8 62.4±54.7**

"

时间 组别 n HA(μg/L) LN(μg/L)
差值的中位数 标准差 差值的百分数(%) 差值的中位数 标准差 差值的百分数(%)
治疗12周 试验组 110 -75.6** 196.5 -36.3 -10.0* 58.3 -8.1
对照组 106 -19.8 222.6 -12.8 3.0 102.2 2.0
治疗24周 试验组 110 -96.1** 201.5 -48.5 -17.0 69.3 -13.0
对照组 106 -26.0 254.6 -15.9 -4.5 108.0 -4.5

"

时间 组别 n P-Ⅲ-P (μg/L) Ⅳ-C (μg/L)
差值的中位数 标准差 差值的百分数(%) 差值的中位数 标准差 差值的百分数(%)
治疗12周 试验组 110 -2.2** 5.0 -20.1 -25.0** 128.2 -39.3
对照组 106 -0.0 5.0 -1.3 -6.5 87.0 -9.1
治疗24周 试验组 110 -2.9** 4.6 -33.9 -33.0** 139.1 -48.3
对照组 106 -0.3 5.5 -3.0 -14.0 80.4 -18.6

"

组别 n 显效例(%) 有效例(%) 无效例(%) P值
试验组 110 80（72.7） 2（1.8） 28（25.5） 0.001
对照组 106 29（27.4） 2（1.9） 75（70.7）

"

项目 组别 n 治 疗 前 治疗6周 治疗12周 治疗18周 治疗24周
Alb(g/L) 试验组 110 40.1±5.2 42.6±5.0** 43.2±4.7** 43.3±4.3**Δ 43.5±5.7**Δ
对照组 106 41.0±5.9 42.6±5.3** 43.3±5.3** 42.8±4.9** 43.1±5.2**
Glb(g/L) 试验组 110 30.1±6.4 29.8±6.1 30.8±6.5 31.3±5.7 31.3±5.8
对照组 106 29.2±5.1 30.9±5.7** 30.9±6.0* 31.9±5.6** 31.9±6.6**
ALT(U/L) 试验组 110 116.0±74.6 57.5±56.0**Δ 50.9±39.0**Δ 50.1±43.6**Δ 49.4±41.2**Δ
对照组 106 96.7±55.0 59.5±52.0** 58.9±54.4** 61.8±58.5** 51.2±39.0**
AST(U/L) 试验组 110 78.4±59.3 55.5±47.7** 54.2±47.4** 46.2±29.2**Δ 48.2±35.0**
对照组 106 68.5±53.1 53.8±39.1** 59.3±50.2* 55.8±39.4* 51.9±51.6**
GGT(U/L) 试验组 110 92.0±71.4 75.3±64.9** 67.9±75.8** 67.4±70.1** 56.4±51.8**ΔΔ
对照组 106 86.8±68.6 68.6±52.9** 67.7±59.9** 70.4±48.0* 67.3±58.2**
ALP(U/L) 试验组 110 100.6±38.2 96.4±47.3* 100.3±52.2 97.9±47.1 93.5±38.8*
对照组 106 95.1±41.9 97.0±43.6 93.1±42.1 91.1±36.5 92.9±41.5
TBIL(μmol/L) 试验组 110 17.8±7.9 15.8±5.9** 15.9±6.4** 15.5±9.5**Δ 15.5±5.8**Δ
对照组 106 16.9±8.4 16.4±8.2 17.1±8.6 18.5±12.1 18.5±13.5
DBIL(μmol/L) 试验组 110 5.9±5.5 4.7±3.0** 4.6±3.0**Δ 4.5±2.5**Δ 4.6±2.7**ΔΔ
对照组 106 5.2±4.4 4.8±3.7 5.1±3.7 5.3±3.6 5.9±5.4

"

组别 n 显效（%） 有效（%） 无效（%） P值
试验组 110 64（58.2） 16（14.5） 30（27.3） 0.105
对照组 106 54（50.9） 9（8.5） 43（40.6）

"

项目 组别 n 治 疗 前 治疗12周 治疗24周
肝门脉主干 试验组 110 12.34±1.94 11.96±1.69**ΔΔ 12.03±1.61*
对照组 106 12.30±1.75 12.37±1.76 12.06±1.51
脾脏厚 试验组 110 42.77±9.23 41.10±8.11** 41.77±7.88
对照组 106 42.45±9.94 42.12±9.90 41.32±8.28*
脾静脉直径 试验组 110 7.57±1.86 7.41±1.84 7.28±1.52*
对照组 106 7.67±1.94 7.43±1.80* 7.39±2.00*

"

组别 n 稳定例/随访总例（％）
HA LN P-Ⅲ-P Ⅳ-C ALT
试验组 50 18/29(62.07) 29/34 (85.29) 14/29 (48.28) 30/34 (88.24) 49/50 (98.00)
对照组 54 16/28(57.14) 25/37 (67.57) 15/25 (60.00) 34/37 (91.89) 54/54 (100.00)
P 值 0.790 0.100 0.425 0.703 0.481
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