目的 系统评价参附注射液（SFI）联合西医常规治疗对急性心肌梗死（AMI）患者经皮冠状动脉介入治疗（PCI）术后的有效性及安全性。方法 计算机检索中国学术期刊全文数据库（CNKI）、万方数据知识服务平台（Wanfang Data）、维普中文期刊全文数据库（VIP）、中国生物医学文献数据库（CBM）、PubMed、Cochrane Library及Web of Science数据库中有关SFI应用于AMI患者PCI术后的临床随机对照试验（RCT），检索时限均为建库起至2023年1月，应用RevMan 5.3软件对收集的数据进行Meta分析。结果 最终纳入12个RCTs，总样本量1 032例，包括试验组520例、对照组521例。Meta分析结果显示，在常规治疗基础上加用SFI在改善主要不良心血管事件（MACE）发生率［RR＝0.19，95% CI （0.12，0.31），P＜0.000 01］、肌酸激酶同工酶［MD＝-32.40，95% CI（-62.65，-2.15），P＝0.04］、B型利钠肽［MD＝-106.76，95% CI（-192.76，-20.76），P＝0.01］、心肌肌钙蛋白T［MD＝-1.25，95% CI（-2.08，-0.43），P＝0.003］、收缩压［MD＝5.73，95% CI （1.67，9.79），P＝0.006］、舒张压［MD＝2.24，95% CI （1.10，3.38），P＝0.000 1］、心率［MD＝-8.84，95% CI（-10.46，-7.22），P＜0.000 01］、TIMI血流分级［RR＝0.58，95% CI（0.46，0.74），P＜0.000 1］及不良反应等方面均优于对照组，但在改善左心室射血分数［MD＝2.48，95% CI （-3.47，8.43），P＝0.41］及左室舒张末期内径［MD＝-1.20，95% CI（-3.67，1.28），P＝0.34］方面两组疗效相当，差异无统计学意义。结论 在西医常规治疗基础上联合SFI能显著降低AMI患者PCI术后MACE发生率、改善患者心功能水平、降低心肌损伤、改善术后TIMI血流分级等，优于西医常规治疗，并且能降低患者不良反应发生率、安全性较好，为临床合理用药提供了有效依据。但纳入文献量较少且质量参差不齐，所得结论仍需更多高质量的RCT加以证实。

Objective To systematically evaluate the efficacy and safety of Shenfu Injection (SFI) combined with conventional western medicine treatment for patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI). Methods Databases such as CNKI, Wanfang Data, VIP, CBM, PubMed, Cochrane Library and Web of Science were searched by computer from foundation to January 2023 to collect randomized controlled trials of application of SFI in AMI patients after PCI. The collected data were analyzed using RevMan 5.3 software for Meta-analysis. Results A total of 12 RCTs were included, involving 1 032 patients, 520 cases in the experimental group and 521 cases in the control group. Meta-analysis showed that adding SFI to conventional Western medicine treatment improved the incidence of MACE events [RR = 0.19, 95%CI (0.12, 0.31), P < 0.000 01], creatine kinase isoenzymes [MD = -32.40, 95%CI (-62.65, -2.15), P = 0.04], B-type natriuretic peptide [MD = -106.76, 95%CI ( - 192.76, - 20.76), P = 0.01], cardiac troponin T [MD = - 1.25, 95%CI ( - 2.08, - 0.43), P = 0.003], and systolic blood pressure [MD = 5.73, 95%CI (1.67, 9.79), P = 0.006] diastolic blood pressure [MD = 2.24, 95%CI (1.10, 3.38), P = 0.000 1], heart rate [MD = -8.84, 95%CI (-10.46, -7.22), P < 0.000 01], TIMI blood flow classification [RR = 0.58, 95%CI (0.46, 0.74), P < 0.000 1], and adverse reactions were better than the control group, but improved left ventricular ejection fraction [MD = 2.48, 95%CI (-3.47, 8.43), P = 0.41] and left ventricular end diastolic diameter [MD = -1.20, 95%CI (-3.67, 1.28), P = 0.34]. The therapeutic effects of the two groups were comparable, and the difference was not statistically significant. Conclusion On the basis of conventional western medicine treatment, the combination of SFI can significantly reduce the incidence of MACE events in patients with acute myocardial infarction after PCI, improve the patient's cardiac function level, reduce myocardial injury, improve postoperative TIMI blood flow grading, etc., which is superior to traditional Western medicine treatment alone, and can reduce the incidence of adverse reactions in patients. The safety is good, providing an effective basis for clinical rational medication. However, the sample size included in the literature is small and the quality is uneven, and the conclusions obtained still need to be confirmed by more highquality RCTs.

R286.1

天津市教委科研计划项目（2021ZD019）