目的 系统评价参麦注射液联合常规化学药治疗冠心病心力衰竭的疗效与安全性。方法 通过计算机检索中国学术期刊全文数据库（CNKI）、万方数据库（WanFang）、维普生物医学数据库（VIP）、中国生物医学文献数据库（CBM）、Pubmed、Embase、Cochrane等中英文数据库进行检索，搜集相关文献从建库—2024年5月。应用Revman 5.4和Stata 15.1软件进行Meta分析，GRADE评价系统进行证据评级。结果 共纳入3项随机对照试验（RCT），样本量2 884例； Meta分析结果显示，参麦注射液联合常规化学药在提高总有效率[RR＝1.23，95% CI（1.19，1.27），P＜0.000 01]、左室射血分数[LVEF，MD＝8.18，95% CI（6.83，9.52），P＜0.000 01]、提高6 min步行距离[6MWT，MD＝59.86，95% CI（28.17，91.56），P＝0.000 2]，降低血浆B型利钠肽[BNP，MD＝-214.27，95% CI （-306.86，-121.67），P＜0.000 01]、左室收缩末期内径[LVESD，MD＝-4.03,95% CI（-6.30，-1.76），P＝0.000 5]和舒张末期内径[LVEDD，MD＝-5.58，95% CI（-8.44，-2.72），P＝0.0001]、左心室收缩末期容积[LVESV，MD＝-18.89，95% CI（-23.44，-14.33），P＜0.000 01)、白细胞介素-6[IL-6，MD＝-6.59，95% CI（-7.75，-5.43]，P＜0.000 01]、肿瘤坏死因子-α[TNF-α，MD＝-38.64，95% CI（-55.91，-21.36），P＜0.000 1]、血清超敏C反应蛋白[hs-CRP，MD＝-2.56，95% CI（-2.88，-2.24），P＜0.000 01]方面优于单纯化学药组。GRADE质量评级结果显示，临床总有效率、hsCRP和不良反应发生方面为低质量证据，其余为极低质量证据。试验序贯分析显示临床总有效率累计纳入的研究穿过了传统界值和TSA界值，进一步肯定了临床疗效。在不良反应发生方面，参麦注射液联合常规化学药更安全，差异有统计学意义[RR＝0.34，95% CI（0.23，0.53），P＜0.000 01]。结论 临床应用参麦注射液联合常规化学药治疗冠心病心力衰竭疗效确切，且安全性更好，推荐临床应用。

Objective Shenmai Injection, a traditional Chinese medicine, has been used in combination with conventional chemical medicine for the treatment of coronary heart disease and heart failure. To systematically evaluate the efficacy and safety of Shenmai Injection as an adjunctive therapy. Methods Computerized searches were performed on Chinese and English databases, including CNKI, WanFang, VIP, CBM, Pubmed, Embase, Cochrane and to collect relevant literature from the establishment of the database until May 2024. Meta-analyses were conducted using RevMan 5.4 and Stata 15.1 software, and the GRADE system was used for evidence grading. Results Three randomized controlled trials (RCTs) with a sample size of 2 884 cases were included; The Meta-analysis results showed that the combination of Shenmai Injection and conventional chemical medicine was superior to chemical medicine alone in terms of improving the total effective rate [RR = 1.23, 95% CI (1.19, 1.27), P <0.000 01], LVEF [MD = 8.18, 95% CI (6.83, 9.52), P <0.000 01], 6MWT [MD = 59.86, 95% CI (28.17, 91.56), P＝ 0.000 2], reducing BNP [MD = -214.27, 95% CI (-306.86, -121.67), P <0.000 01], LVESD and LVEDD [MD = -4.03, 95% CI (-6.30, -1.76), P＝ 0.000 5]; [MD = -5.58, 95% CI (-8.44, -2.72), P＝ 0.000 1], LVESV [MD = -18.89, 95% CI [-23.44, -14.33], P <0.000 01], IL-6 [MD = -6.59, 95% CI -7.75, -5.43), P <0.000 01], TNF-α [MD = -38.64, 95% CI (-55.91, -21.36), P <0.000 1], and hs-CRP [MD = -2.56, 95% CI (-2.88, -2.24), P <0.000 01]. The GRADE quality rating results showed low-quality evidence for the total effective rate, hs-CRP, and adverse reactions, and very low-quality evidence for the rest of the outcomes. The trial sequence analysis showed that the cumulative number of studies on the total effective rate crossed both the traditional threshold and the TSA threshold, further confirming the clinical efficacy. In terms of adverse reactions, the combination of Shenmai Injection and conventional chemical medicine was safer, with a statistically significant difference [RR = 0.34, 95% CI (0.23, 0.53), P <0.000 01]. Conclusion The combination of Shenmai Injection and conventional chemical medicine is effective and safer for the treatment of coronary heart disease and heart failure. It is recommended for clinical application.

R974

国家自然科学基金资助项目（82204885）；天津自然科学基金项目（23JCONJC01070）