目的 评估恩替卡韦联用扶正化瘀胶囊（Fuzheng Huayu Capsules，FHC）、复方鳖甲软肝片（Fufang Biejia Ruangan Tablets，BRT）及安络化纤丸（Anluo Huaxian Pills，AHP）治疗慢性乙型肝炎（chronic hepatitis B，CHB）肝纤维化的效益与风险，指导临床合理用药。方法 应用多准则决策分析模型，确定效益风险指标，建立价值树。检索筛选随机对照试验（andomized controlled trials，RCTs）与半随机对照试验（quasi-randomized controlled trials，qRCTs）。通过Meta分析生成合并值，并根据摆动权重法为各指标进行赋权，采用Hiview 3软件计算恩替卡韦联用中药的效益值、风险值和效益风险总值，利用蒙特卡洛模拟优化研究结果。应用敏感性分析检验结果稳定性。结果 恩替卡韦联用FHC、BRT、AHP的效益值分别为32、27、31，风险值分别为70、56、63，效益风险总值分别为51、41、47，恩替卡韦联用FHC作为最优用药方案与BRT、AHP联用方案的差异分别为10 [95% CI (3，154)]，4 [95% CI (−121，137)]，差异大于0的概率为98.37%和54.35%。结论 恩替卡韦联用3种中药治疗CHB肝纤维化的疗效显著，安全性较好；其中，联用FHC临床应用优先级最高。因此，恩替卡韦联用FHC方案值得进一步推广。

Objective To evaluate the benefits and risks of entecavir combined with Fuzheng Huayu Capsules (FHC, 扶正化瘀胶囊), Fufang Biejia Ruangan Tablets (BRT, 复方鳖甲软肝片) and Anluo Huaxian Pills (AHP, 安络化纤丸) in the treatment of chronic hepatitis B (CHB) liver fibrosis, in order to provide reference for clinical rational drug use. Method The multi-criteria decision analysis model was applied to determine benefit and risk indicators and establish the value tree. The randomized controlled trials (RCTs) and quasi-randomized controlled trials (qRCTs) were searched and screened. The combined value were generated through Meta-analysis, and each index was weighted according to the swing weight method. The Hiview 3 software was used to calculate the benefit value, risk value and total benefit risk value of entecavir combined with traditional Chinese medicine, and Monte Carlo simulation was used to optimize the research results. Sensitivity analysis was used to test the stability of the results. Results The benefits of entecavir combined with FHC, BRT, and AHP were 32, 27, 31. The risk values were 70, 56, 63, and the total benefits and risks were 51, 41, 47. The difference between entecavir combined with FHC as the optimal drug regimen and BRT, AHP combined regimens were 10 [95% CI (3, 154)], 4 [95% CI (−121, 137)], and the probability that the difference was greater than 0 was 98.37% and 54.35%. Conclusion Entecavir combined with three traditional Chinese medicines has significant efficacy and safety in the treatment of CHB liver fibrosis. Among them, the combination of FHC has the highest priority for clinical application. Therefore, entecavir combined with FHC program is worthy of further promotion.

R285.64

成都中医药大学杏林学者学科人才科研提升计划（CXTD2018005）