目的 系统评价芪苈强心胶囊联合沙库巴曲缬沙坦治疗慢性心力衰竭（chronic heart failure，CHF）的疗效及安全性。方法 计算机检索PubMed、Embase、The Cochrane Library、中国学术期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、维普中文期刊全文数据库（VIP）、万方数据库，收集芪苈强心胶囊联合沙库巴曲缬沙坦治疗CHF的临床随机对照试验（RCT）。检索时限从建库至2021年8月31日，评价纳入文献的偏倚风险后，采用Revman 5.3软件进行Meta分析。结果 共纳入17篇RCTs，包括患者1 511例。Meta分析结果显示：芪苈强心胶囊联合沙库巴曲缬沙坦比单纯使用沙库巴曲缬沙坦或芪苈强心胶囊，可以明显提高总有效率［OR=3.49，95% CI（2.48，4.92），P<0.000 01］，增加6 min步行距离（6MWD）［MD=78.92，95% CI （34.24，123.60），P<0.000 01］，增加左室射血分数（LVEF）［MD=5.57，95% CI（4.98%，6.17%），P<0.000 01］，减小左心室舒张末期内径（LVEDD）［MD=-4.12，95% CI（-5.49，-2.74），P<0.000 01］，减小左心室收缩末期内径（LVESD）［MD=-3.26，95% CI（-4.46，-2.07），P<0.000 01］，降低N末端脑利钠肽前体（NT-proBNP）［MD=-534.61，95% CI（-708.82，-360.39），P<0.000 01］，降低生活质量评价MLHFQ评分［MD=-13.02，95% CI（-13.99，-12.05），P<0.000 01］，不良事件发生率无显著性差异［MD=0.91，95% CI（0.41，1.99），P=0.8］。结论 芪苈强心胶囊联合沙库巴曲缬沙坦在治疗CHF的疗效优于单用沙库巴曲缬沙坦或芪苈强心胶囊，对于改善CHF患者心功能和提高生活质量是安全有效的，上述结论尚需更高质量的随机双盲对照研究予以验证。

Objective To systematically evaluate the efficacy and safety of Qili Qiangxin Capsule (QLQX) combined with Sacubitril/Valsartan in the treatment of chronic heart failure (CHF). Methods A literature search was conducted across PubMed, Embase, Cochrane Library, CNKI, CBM, Wanfang, and VIP from the establishment of database to 31 August 2021 to search for randomised controlled trials (RCT) comparing QLQX combined with Sacubitril/Valsartan with Sacubitril/Valsartan in CHF. Literatures were evaluated the risk of bias of included literatures, and Meta-analyses were performed by using Revman 5.3 software. Results A total of 17 studies involving 1 511 participants were included. Meta-analysis results showed that QLQX combined with Sacubitril/Valsartan significantly increased the effective rate[OR=3.49, 95%CI (2.48, 4.92), P < 0.000 01] and increased 6MWD[MD=78.92, 95%CI (34.24, 123.60), P < 0.000 01], increased LVEF[MD=5.57, 95%CI (4.98%, 6.17%), P < 0.000 01], decreased LVEDD[MD=-4.12, 95%CI (-5.49, -2.74), P < 00.000 01], decreased LVESD[MD=-3.26, 95%CI (-4.46, -2.07), P < 0.000 01], decreased serum brain natriuretic peptide[MD=-534.61, 95%CI (-708.82, -360.39), P < 0.000 01], decreased the MLHFQ score[MD=-13.02, 95%CI (-13.99, -12.05), P < 00.000 01], and there was no significant difference in adverse events[MD=0.91, 95%CI (0.41, 1.99), P=0.8]. Conclusion Meta-analysis indicated that QLQX combined with Sacubitril/Valsartan therapy is safe and effective to improve cardiac function and quality in CHF patients, which required more high-quality, multi-center randomized double-blind clinical trials for further validation.

R286.5

新疆维吾尔自治区药学会科研基金资助项目（YXH201922）