目的 探讨扶正化瘀胶囊联合恩替卡韦治疗慢性乙型肝炎肝纤维化的临床疗效和作用机制。方法 2013年5月—2013年11月西宁市第一人民医院收治的慢性乙型肝炎肝纤维化112例，随机分为治疗组（56例）和对照组（56例），治疗组口服恩替卡韦片1片/次，1次/d，同时口服扶正化瘀胶囊1粒/次，3次/d。对照组给予恩替卡韦片，用法用量同治疗组，同时口服安慰剂1粒/次，3次/d。两组患者均连续治疗24周。比较两组症状、肝纤维化及炎症程度、肝功能、肝纤维化指标及Fas表达。结果 治疗组患者乏力、肝区疼痛、厌食、腹胀的改善率均高于对照组，两组比较差异有统计学意义（P<0.01）。治疗后，两组纤维化、炎症活动程度、肝功能均明显好转，同组治疗前后差异有统计学意义（P<0.01）；且治疗组的改善程度优于对照组，两组比较差异有统计学意义（P<0.05、0.01）。两组丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转氨酶（AST）均较治疗前降低，同组治疗前后差异有统计学意义（P<0.01），治疗24周时治疗组ALT水平显著低于对照组，两组比较差异有统计学意义（P<0.05）。治疗后，两组患者肝纤维化指标透明质酸（HA）、层粘连蛋白（LN）、IV型胶原（C-IV）、Ⅲ型前胶原（PCⅢ）、HBV DNA拷贝数和Fas表达均较治疗前显著降低，同组治疗前后差异有统计学意义（P<0.01），且治疗组比同期对照组改善更加明显，两组比较差异有统计学意义（P<0.01）。结论 扶正化瘀胶囊联合恩替卡韦治疗慢性乙型肝炎肝纤维化具有较好的临床疗效，可以更好的改善患者的症状，改善患者肝纤维化和炎症活动程度，值得临床推广应用。

Objective To investigate the effect of Fuzheng Huayu Capsule combined with entecavir in the treatment of chronic hepatitis B with liver fibrosis and its mechanism. Methods Collecting 112 cases suffered from chronic hepatitis B with liver fibrosis from May 2013 to November 2013 in the First People's Hospital of Xining, which were randomly divided into treatment group (56 cases) and control group (56 cases). Patients in the treatment group were po administered with Entecavir Tablets, 1 tablet each time, once daily. At the same time, they were po administered with Fuzheng Huayu Capsule, 1 grain each time, three times daily. Patients in the control group were po administered with Entecavir Tablets, and the usage and dosage were the same as the treatment group. And they were po administered with placebo, 1 grain each time, three times daily. Two groups were treated for 24 weeks. The symptoms, the degree of liver fibrosis and inflammation, liver function, the indexes of hepatic fibrosis and the expression of Fas in the two groups were compared. Results The improvement rates of fatigue, liver area pain, anorexia, abdominal distension in the treatment group were higher than those in the control group, with significant difference between the two groups (P < 0.01). After the treatment, the degree of fibrosis, inflammation activity, and liver function in the two groups were significantly improved, and the difference was statistically significant before and after the treatment in the same group (P < 0.01). And the degree of the improvement in the treatment group was better than that in the control group, with the significant difference between the two groups (P < 0.05, 0.01). ALT and AST in the two groups were reduced, and the difference was statistically significant before and after the treatment in the same group (P < 0.01). ALT in the treatment group was lower than that in the control group for treatment at 24 weeks, with significant difference between the two groups (P < 0.05). After the treatment, the indexes of liver fibrosis, such as HA, LN, C-IV, PC Ⅲ, copy number of HBV DNA, and Fas expression were significantly reduced, and the difference was statistically significant before and after the treatment in the same group (P < 0.01). And the patients in the treatment group improved more obviously than those in the control group in the same time of the treatment, with the significant difference between two groups (P < 0.01). Conclusion Fuzheng Huayu Capsule combined with entecavir has good clinical effect in the treatment of chronic hepatitis B with liver fibrosis, and could better improve the symptom of the patients, at the same time, improve the degree of fibrosis and inflammation activity, which is worthy of clinical application.