【摘要】 目的 评价九味柔肝颗粒治疗慢性乙肝肝纤维化的疗效和安全性。 方法 根据纳入与排除标准，选取2007年2-8月入院的慢性乙肝肝纤维化（气滞血瘀兼湿热未净证）患者96例，按3∶1随机分为两组进行随机双盲双模拟对照试验。试验组72例，口服九味柔肝颗粒， 2次/d，每次10 g；阳性对照药鳖甲软肝片组（对照组）24例，口服鳖甲软肝片，4片/次，3次/d；两组疗程均为6个月。 结果 试验组完成治疗66例，对照组完成21例。符合方案数据分析（PPS）结果显示，试验组治疗后中医证侯积分及B超积分分别下降了0.50±1.04和8.61±3.62，对照组分别下降了0.32±1.01和8.63±3.15，均较治疗前显著下降（Plt;0.05），两组比较无统计学意义（Pgt;0.05）。在血清肝纤维化四项指标方面，试验组除LN外，其余指标治疗后均较治疗前明显下降（Plt;0.05），对照组中仅PⅢP有显著下降（Plt;0.05），其余指标下降不明显，两组比较无统计学意义（Pgt;0.05）。两组患者治疗期间均未观察到明显不良反应，不良反应发生率分别为5.56%和4.17%。 结论 九味柔肝颗粒能明显改善慢性肝炎肝纤维化患者的症状和部分肝纤维化指标，其疗效与鳖甲软肝片相当，安全性良好。【Abstract】 Objective To assess the safety and therapeutic effect of Jiuweirougan grandule on chronic hepatitis B with hepatic fibrosis. Methods A double-blind, double dummy and randomized controlled method was adopted. Ninety-six patients from February to August 2007 selected by including and excluding criteria were distributed randomly in accordance with the 3∶1 ratio into the test group (n=72, treated with Jiuweirougan 10 g, two times per day) and the control group (n=24, treated with Biejiaruangan 4 tablets, three times per day). The period of treatment for both groups lasted for half a year. Results A total of 66 cases in the test group and 21 cases in the control group completed the experiment. The results of per-protocol population (PPS) suggested that the accumulated score of B ultrasound and symptom decreased 0.50±1.04 and 8.61±3.62 in the test group and 0.32±1.01 and 8.63±3.15 in the control group, respectively. The score decreased remarkably compared with pre-treatment(Plt;0.05). There was no significant difference between the two groups (Pgt;0.05). For serum liver fibrotic parameters, all parameters except laminin (LN) in the test group decreased remarkably compared with pre-treatment(Plt;0.05). But in the control group, besides type Ⅲ procollagen (PCⅢ) decreased remarkably(Plt;0.05), other parameters showed no obvious changes. There was no significant difference between the two groups (Pgt;0.05). At the same time, no obvious adverse effect was found in the two groups. The incidence of adverse reactions was 5.56% and 4.17% respectively. Conclusion Jiuweirougan granule may improve the syndrome and part of fibrotic index of chronic hepatitis B with fibrosis, and the effect is equal to that of Biejiaruangan with good security.