目的:观察扶正化瘀胶囊治疗慢性乙型肝炎肝纤维化的临床疗效及安全性。方法:多中心、随机、双盲、平行对照,对照药为和络舒肝胶囊,疗程24周并随访12周。结果:试验组110例, 对照组106例,其中治疗前进行肝组织学检查者分别为99例和96例,治疗后作2次肝活检者分别为50例和43例。治疗后,试验组纤维化分期降低1期以上者占52％,显著高于对照组（23．3％）, 同时肝组织炎症活动度显著下降;试验组治疗12周、24周时的血清HA、LN、P-Ⅲ-P及Ⅳ-C含量较治疗前均显著下降,其差值均显著大于对照组;两组血清Alb、ALT、AST、GGT、ALP均有显著改善;但试验组血清ALT改善率、GGT的下降值及Alb含量的增加值均显著大于对照组。未发现有临床意义的不良反应。停药12周后试验组和对照组的血清学纤维化指标和ALT稳定率比较无显著性差异。结论:扶正化瘀胶囊是治疗慢性乙型肝炎肝纤维化安全、有效的药物。

Objective: To observe the efficacy and safety of Fuzhenghuayu （strengthening healthy Qi to solve stagnation） Capsules in liver fibrosis caused by chronic hepatitis B. Method: Trials of multi - center, randomization, double blindness and parallel control （with Heluoshugan Capsules as control medicine） are conducted in patients suffering from liver fibrosis caused by Chronic hepatitis B in 24 weeks and followed by 12 -week visit. Result: 110 cases of the experimental group and 106 cases of the control group have been placed into the trial, among which 99 cases and 96 cases went through the examination of liver biopsy before treatment and 50 cases and 43 cases recieved twice the examination of liver biopsy after treatment respectively. And after treatment 52% of those in the experimental group has decreased more than 1 stage in the staging score of liver fibrosis, which is notfably higher than that of those in the control group （23.3%） and the index of their hipatic inflammation activity has lowered down remarkably as well. In comparison with the pretreatment the contents of HA, LN, P - Ⅲ- P and Ⅳ- C of those in the experimental group have significantly gone down and the rate of their difference is greater than those in the control group. The serum Alb, ALT, AST, GGT and ALP of the testees in the two groups have been greatly improved, but the improvement rate of ALT, the drop - out value of GGT and the increase value of Alb of the testees in the experimental group are much higher than those of the testees in the cortrol group respectively. No untoward effect with clinical significance has emerged. After 12 week's withdrawal of treatment appears little difference of serological parameters and the stability rate of ACT between the two groups. Conclusion: Fuzhenhuayu Capsule is a Chinese medicine which can be able to treat chronic hepatitis B safely and efficaciously.

上海市医学发展基金重点研究项目(No:99ZD1001):复方319胶囊干预肝纤维化的研究，负责人：刘平，胡义扬。