目的 探討扶正化瘀膠囊聯(lián)合恩替卡韋治療慢性乙型肝炎肝纖維化的臨床療效和作用機(jī)制。方法 2013年5月—2013年11月西寧市第一人民醫(yī)院收治的慢性乙型肝炎肝纖維化112例，隨機(jī)分為治療組（56例）和對(duì)照組（56例），治療組口服恩替卡韋片1片/次，1次/d，同時(shí)口服扶正化瘀膠囊1粒/次，3次/d。對(duì)照組給予恩替卡韋片，用法用量同治療組，同時(shí)口服安慰劑1粒/次，3次/d。兩組患者均連續(xù)治療24周。比較兩組癥狀、肝纖維化及炎癥程度、肝功能、肝纖維化指標(biāo)及Fas表達(dá)。結(jié)果 治療組患者乏力、肝區(qū)疼痛、厭食、腹脹的改善率均高于對(duì)照組，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.01）。治療后，兩組纖維化、炎癥活動(dòng)程度、肝功能均明顯好轉(zhuǎn)，同組治療前后差異有統(tǒng)計(jì)學(xué)意義（P<0.01）；且治療組的改善程度優(yōu)于對(duì)照組，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05、0.01）。兩組丙氨酸氨基轉(zhuǎn)移酶（ALT）、天冬氨酸氨基轉(zhuǎn)氨酶（AST）均較治療前降低，同組治療前后差異有統(tǒng)計(jì)學(xué)意義（P<0.01），治療24周時(shí)治療組ALT水平顯著低于對(duì)照組，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療后，兩組患者肝纖維化指標(biāo)透明質(zhì)酸（HA）、層粘連蛋白（LN）、IV型膠原（C-IV）、Ⅲ型前膠原（PCⅢ）、HBV DNA拷貝數(shù)和Fas表達(dá)均較治療前顯著降低，同組治療前后差異有統(tǒng)計(jì)學(xué)意義（P<0.01），且治療組比同期對(duì)照組改善更加明顯，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.01）。結(jié)論 扶正化瘀膠囊聯(lián)合恩替卡韋治療慢性乙型肝炎肝纖維化具有較好的臨床療效，可以更好的改善患者的癥狀，改善患者肝纖維化和炎癥活動(dòng)程度，值得臨床推廣應(yīng)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.