扶正化瘀胶囊干预慢性乙型肝炎肝纤维化作用的多中心临床研究

目的　研究扶正化瘀胶囊治疗慢性乙型肝炎肝纤维化的临床疗效及其安全性。方法　多中心、随机、双盲、平行对照的方法 ,入选年龄 18～ 65岁的慢性乙型肝炎肝纤维化患者。试验药 (扶正化瘀胶囊 )和对照药 (和络舒肝胶囊 ) ,均为每次 5粒 ,3次 /d口服 ;疗程 2 4周。疗程结束后进行 12周的随访。观测指标 :(1)于治疗第 0、2 4周观察肝组织病理学、HBV标志物 ,第 0、12、2 4周检测肝纤维化血清指标 (HA、LN、P Ⅲ P、Ⅳ C)、B超肝脾检查 ,第 0、6、12、18、2 4周观察肝功能 (随访期评价肝功能、血清肝纤维化指标 )。 (2 )安全性指标 :治疗前、后检测血、尿常规 ,肾功能 ,心电图。结果　 (1)受试者入组情况及人口学资料 :试验组 110例 ,对照组 10 6例 ,两组病例人口学特征、生命体征、病程、药物过敏史、既往治疗史、肝功能、纤维化血清学指标、肝组织病理学 (试验组 99例 ,对照组 96例 )、HBV标志物、肾功能等各项指标比较 ,无显著差异。 (2 )肝组织病理学 :治疗前后作活检肝组织学观察 93例 ,试验组 50例和对照组 43例治疗前纤维化分期 (S)均值分别为 2 .3 3和 2 .11。试验组治疗后S均值为 1.80 ,较治疗前显著下降。对照组治疗后S均值为 2 .14 ,与治疗前比较无显著改善。试验组活检肝组织纤维化分期判断

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

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.