目的 系統(tǒng)評價注射用益氣復脈（凍干）聯(lián)合常規(guī)化學藥治療冠心病心力衰竭有效性及安全性。方法 系統(tǒng)檢索中國學術(shù)期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫（Wanfang Data）、維普生物醫(yī)學數(shù)據(jù)庫（VIP）、SinoMed、PubMed、CochraneLibrary、Embase和Web of Science共8個數(shù)據(jù)庫，收集從建庫至2024年7月31日期間發(fā)表的關(guān)于注射用益氣復脈（凍干）聯(lián)合常規(guī)化學藥治療冠心病心力衰竭的隨機對照試驗（RCTs）。采用RevMan 5.4軟件進行Meta分析，并參照Cochrane風險偏倚評估標準文獻質(zhì)量進行評估。結(jié)果 共納入17項RCT，總樣本量為1 644例。Meta分析結(jié)果顯示：相比常規(guī)化學藥治療冠心病心力衰竭，試驗組在對照組的基礎(chǔ)上聯(lián)用注射用益氣復脈（凍干）能有效提升患者的臨床總有效率［RR＝1.20，95% CI（1.13，1.27），P＜0.000 01］、左室射血分數(shù)（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］，縮小左室舒張末期內(nèi)徑（LVEDD）［MD＝-5.56，95% CI（-8.68，-2.44），P＜0.000 5］、左室收縮末期內(nèi)徑（LVESD）［MD＝-4.38，95% CI（-8.51，-0.25），P＝0.04］，降低N末端B型利鈉肽前體（NT-proBNP）水平［MD＝-438.21，95% CI（-598.37，-278.05），P＜0.000 01］，提升6 min步行距離（6MWT）［MD＝54.97，95% CI（37.87，72.08），P＜0.000 01］，降低明尼蘇達州心功能不全生活質(zhì)量量表（MLHFQ）評分［MD＝-6.24，95% CI（-8.71，-3.77），P＜0.000 01］。在不良反應方面，2組間的不良反應發(fā)生率無統(tǒng)計學差異。進一步敏感性分析提示，除LVESD、SV外，其余指標統(tǒng)計分析結(jié)果均穩(wěn)健可靠。結(jié)論 在常規(guī)化學藥治療的基礎(chǔ)上聯(lián)用注射用益氣復脈（凍干）能有效改善冠心病心力衰竭患者的臨床總有效率、心功能指標、心衰標志物水平、運動質(zhì)量以及生活質(zhì)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

國家青年科學基金項目（82200349）；廣東省基礎(chǔ)與應用基礎(chǔ)研究基金面上項目（2022A1515011647）