目的 评估芪参益气滴丸联合沙库巴曲缬沙坦治疗慢性心力衰竭（chronic heart failure，CHF）的效益与风险，指导实际临床合理用药。方法 检索数据库中芪参益气滴丸联合沙库巴曲缬沙坦治疗CHF的随机对照研究（randomized controlled trials，RCTs），检索时间截至2023年7月1日。根据纳排标准筛选文献，按照不同方案分为单用沙库巴曲缬沙坦的对照组和联用芪参益气滴丸的观察组，利用RevMan 5.3软件合并效益风险指标，构建基于多准则决策分析（multi-criteria decision analysis，MCDA）模型的评价体系；利用Hiview 3软件计算芪参益气滴丸联合沙库巴曲缬沙坦治疗CHF的相关效益值、风险值及效益风险总值，采用蒙特卡洛模拟以优化所得结果，并通过敏感性分析验证所得结果的稳定性。结果 最终纳入6项RCTs。MCDA模型评价结果显示，当一级指标效益和风险权重分别占比78%和22%时，单用沙库巴曲缬沙坦与联用芪参益气滴丸的效益风险总值分别为31和63，蒙特卡洛模拟后差异为−32 [95% CI (−48, −17)]，评价结果稳定性较好。结论 芪参益气滴丸联合沙库巴曲缬沙坦治疗CHF较单用组的疗效显著，安全性较好；基于MCDA模型建立了芪参益气滴丸联合沙库巴曲缬沙坦治疗CHF的效益风险评价体系，为决策者临床合理应用中西药联合治疗疾病提供参考依据。

Objective To evaluate the benefits and risks of Qishen Yiqi Dropping Pills (芪参益气滴丸) combined with sacubitril valsartan in the treatment of chronic heart failure (CHF), and guide the rational use of medicine in actual clinical practice. Methods Randomized controlled trials (RCTs) on QishenYiqi Dropping Pills combined with sacubitril valsartan in the treatment of CHF were searched from multiple databases and the search deadline was July 1, 2023. According to the inclusion and exclusion criteria, the literature was screened and divided into the control group with sacubitril valsartan alone and the observation group with Qishen Yiqi Dropping Pills in combination. RevMan 5.3 was used to merge the data to obtain the benefit-risk indicators.The evaluation system based on multi-criteria decision analysis (MCDA) model was constructed. The benefit value, risk value, and benefit-risk value associated with the use of Qishen Yiqi Dropping Pills combined with sacubitril valsartan in the treatment of CHF were calculated by using Hiview 3. The Monte Carlo simulation was used to optimize the obtained results, and the stability was verified by sensitivity analysis. Results Six RCTs were finally included. The MCDA model evaluation showed that when the benefit and risk weights of the primary indicators of the two regimens were 78% and 22%, respectively, the total benefit-risk values of sacubitril valsartan alone and in combination with Qishen Yiqi Dropping Pills were 31 and 63, with a difference of −32 [95% CI (−48, −17)], and the opposite result did not occur after Monte Carlo simulation. The evaluation result was stable. Conclusion The efficacy and safety of Qishen Yiqi Dropping Pills combined with sacubitril valsartan in the treatment of CHF were remarkable. Based on the MCDA model, this study established the benefit-risk evaluation system of Qishen Yiqi Dropping Pills combined with sacubitril valsartan in the treatment of CHF, which provided a reference for decision makers to rationally use the combination of Chinese and western medicine in the treatment of diseases.

R285.64

天津市中医药重点领域科研项目：加参方联合化药治疗慢性心衰获益-风险评估（2024004）