目的 系统评价麝香保心丸（SXBX）联合常规化学药在降低冠心病患者经皮冠状动脉介入治疗（PCI）后主要不良心血管事件（MACE）和改善生活质量方面的疗效及安全性，为临床决策提供循证依据。方法 计算机检索中国学术期刊全文数据库（CNKI）、维普生物医学数据库（VIP）、万方数据库（Wanfang Data）、SinoMed、PubMed、Cochrane Library、Embase及Web of Science，获取自建库至2025年6月30日关于SXBX联合常规化学药治疗冠心病患者PCI术后的随机对照试验（RCT）。经过2名研究者独立筛选文献、提取数据并交叉核对后采用Revman 5.4软件进行Meta分析。采用Cochrane手册第6版评估偏倚风险。结果 共纳入29项RCT（2 960例）。与单用常规化学药相比，SXBX联合治疗显著降低PCI术后MACE总体风险：心肌再梗死［RD＝-0.03，95%置信区间（CI）（-0.05，-0.02），P＜0.000 1］、再发心绞痛［RD＝-0.04，95% CI（-0.06，-0.02），P＜0.000 1］、心力衰竭［RD＝-0.03，95% CI（-0.04，-0.01），P＝0.009］及心律失常[RD＝-0.04，95% CI（-0.06，-0.01），P＝0.001]；西雅图心绞痛量表（SAQ） 5个维度评分均显著提高；次要结局指标方面，联合治疗较对照组提高左室射血分数（LVEF） 3.73%［MD＝3.73，95% CI（2.57，4.90），P＜0.000 01］，显著降低超敏C反应蛋白（hsCRP）水平［MD＝-2.79，95% CI（-3.70，-1.89），P＜0.000 01］。两组不良反应发生率差异无统计学意义［RD＝0.00，95% CI（-0.03，0.03），P＝0.78］。结论 在常规化学药基础上加用SXBX可显著减少冠心病PCI术后早期MACE，改善心功能、减轻炎症反应并提高生活质量，且安全性良好。

Objective To systematically evaluate the efficacy and safety of Shexiang Baoxin Pill (SXBX) combined with conventional western medicine in reducing major adverse cardiovascular events (MACE) and improving quality of life in patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI). Methods Eight Chinese and English databases (CNKI, VIP, Wanfang, SinoMed, PubMed, Cochrane Library, Embase and Web of Science) were searched from inception to 30 June 2025 for randomized controlled trials (RCT) that administered SXBX plus conventional Western medicine after PCI. Two investigators independently screened the literature, extracted data and cross-checked consistency; RevMan 5.4 was used for the Meta-analysis, and risk of bias was assessed according to the Cochrane Handbook (version 6). Results Twenty-nine RCT comprising 2 960 participants were included. Compared with conventional western medicine alone, combined therapy significantly reduced the overall risk of MACE: myocardial re-infarction [RD = -0.03, 95%CI (-0.05, -0.02), P < 0.000 1], recurrent angina [RD = -0.04, 95%CI (-0.06, -0.02), P < 0.000 1], heart failure [RD = -0.03, 95%CI (-0.04, -0.01), P = 0.009] and arrhythmia [RD = -0.04, 95%CI (-0.06, -0.01), P = 0.001]. All five dimensions of the Seattle Angina Questionnaire (SAQ) were significantly improved. Additional outcomes showed a 3.73 % increase in left ventricular ejection fraction [MD = 3.73, 95%CI (2.57, 4.90), P < 0.000 01] and a significant reduction in highsensitivity C-reactive protein [MD = -2.79, 95%CI (-3.70, -1.89), P < 0.000 01]. No statistically significant difference in adverse events was observed between groups [RD = 0.00, 95%CI (-0.03, 0.03), P = 0.78]. Conclusion The addition of SXBX to conventional chemical drugs can significantly reduce early MACE after coronary heart disease PCI, improve cardiac function, reduce inflammatory reactions, and enhance quality of life, 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）