目的 系统评价注射用益气复脉（冻干）联合常规化学药治疗冠心病心力衰竭有效性及安全性。方法 系统检索中国学术期刊全文数据库（CNKI）、万方数据库（Wanfang Data）、维普生物医学数据库（VIP）、SinoMed、PubMed、CochraneLibrary、Embase和Web of Science共8个数据库，收集从建库至2024年7月31日期间发表的关于注射用益气复脉（冻干）联合常规化学药治疗冠心病心力衰竭的随机对照试验（RCTs）。采用RevMan 5.4软件进行Meta分析，并参照Cochrane风险偏倚评估标准文献质量进行评估。结果 共纳入17项RCT，总样本量为1 644例。Meta分析结果显示：相比常规化学药治疗冠心病心力衰竭，试验组在对照组的基础上联用注射用益气复脉（冻干）能有效提升患者的临床总有效率［RR＝1.20，95% CI（1.13，1.27），P＜0.000 01］、左室射血分数（LVEF）［MD＝5.86，95% CI（4.72，7.00），P＜0.000 01］、每搏量（SV）［MD＝1.86，95% CI（0.49，3.23），P＝0.008］，缩小左室舒张末期内径（LVEDD）［MD＝-5.56，95% CI（-8.68，-2.44），P＜0.000 5］、左室收缩末期内径（LVESD）［MD＝-4.38，95% CI（-8.51，-0.25），P＝0.04］，降低N末端B型利钠肽前体（NT-proBNP）水平［MD＝-438.21，95% CI（-598.37，-278.05），P＜0.000 01］，提升6 min步行距离（6MWT）［MD＝54.97，95% CI（37.87，72.08），P＜0.000 01］，降低明尼苏达州心功能不全生活质量量表（MLHFQ）评分［MD＝-6.24，95% CI（-8.71，-3.77），P＜0.000 01］。在不良反应方面，2组间的不良反应发生率无统计学差异。进一步敏感性分析提示，除LVESD、SV外，其余指标统计分析结果均稳健可靠。结论 在常规化学药治疗的基础上联用注射用益气复脉（冻干）能有效改善冠心病心力衰竭患者的临床总有效率、心功能指标、心衰标志物水平、运动质量以及生活质量，且安全性良好。

Objective To comprehensively assess the therapeutic efficacy and safety profile of Yiqi Fumai Lyophilized Injection when used in conjunction with conventional western medicine for patients suffering from coronary heart disease accompanied by heart failure.Methods A comprehensive search was conducted for randomized controlled trials (RCTs) that examined the use of Yiqi Fumai Lyophilized Injection in conjunction with conventional western medicine for the treatment of coronary heart disease with heart failure. The search spanned eight databases: CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, Embase, and Web of Science, covering all records from the inception of each database up to July 31, 2024. Included studies were used for Meta-analysis on Rev Man 5.4 software, and the Cochrane risk of bias tool in the Cochrane Handbook was used to assess the quality of the included studies.Results A total of 1 644 patients were included in 17 studies. The Meta-analysis results showed that, on the basis of conventional western medicine treatment, the combination of Yiqi Fumai Lyophilized Injection could further improve the clinical total effective rate [RR = 1.20, 95%CI (1.13, 1.27), P<0.000 01], left ventricular ejection fraction (LVEF) [MD = 5.86, 95%CI (4.72, 7.00), P<0.000 01] and stroke volume (SV) [MD = 1.86, 95%CI (0.49, 3.23), P = 0.008] in patients with coronary heart disease complicated with heart failure, reduce left ventricular end-diastolic diameter (LVEDD) [MD = -5.56, 95%CI (-8.68, -2.44), P<0.000 5] and left ventricular end-systolic diameter (LVESD) [MD = -4.38, 95%CI (-8.51, -0.25), P = 0.04], decrease the level of N-terminal pro-B-type natriuretic peptide (NT-proBNP) [MD = -438.21, 95%CI (-598.37, -278.05), P<0.000 01], increase the 6-min walk test (6MWT) distance [MD = 54.97, 95%CI (37.87, 72.08), P<0.000 01], and lower the Minnesota quality of life questionnaire for heart failure (MLHFQ) score [MD = -6.24, 95%CI (-8.71, -3.77), P<0.000 01]. There was no statistical difference in the incidence of adverse reactions between the two groups. Further sensitivity analysis suggested that, except for LVESD and SV, the statistical analysis results of the other indicators were robust and reliable.Conclusion The combination of Yiqi Fumai Lyophilized Injection with conventional western medicine can effectively improve the clinical total effective rate of cardiac function, cardiac function indicators, heart failure biomarker levels, exercise capacity, and quality of life in patients with coronary heart disease complicated with heart failure, and with good safety.

R972

国家青年科学基金项目（82200349）；广东省基础与应用基础研究基金面上项目（2022A1515011647）