目的 系统评价复方丹参滴丸联合化学药治疗对行经皮冠状动脉介入术（PCI）后的冠心病患者不良心血管事件及心脏功能的影响。方法 通过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）、中国生物医学文献服务系统（SinoMed）、PubMed、Cochrane Library、Embase、Web of Science 8个数据库检索复方丹参滴丸治疗冠心病患者PCI术后的临床随机对照试验（RCTs），检索时限从建库至2023年10月31日。使用Cochrane手册中的Cochrane风险测试偏倚工具来评估纳入研究的质量，Review Manager 5.4软件对结果进行分析。结果 最终纳入26项RCTs，总样本量3 384例，包括治疗组1 692例、对照组1 692例。Meta分析结果显示：在主要结局方面，与对照组比较，治疗组可显著减少心绞痛复发[RR=0.27，95% CI （0.16，0.45），P<0.000 01]、再发非致死性心肌梗死[RR=0.30，95% CI （0.15，0.60），P=0.000 7]、心律失常[RR=0.75，95% CI （0.62，0.90），P=0.002]、心力衰竭[RR=0.36，95% CI （0.21，0.60），P<0.000 1]、再次血运重建[RR=0.18，95% CI （0.05，0.66），P=0.01]、支架内再狭窄[RR=0.23，95% CI （0.10，0.57），P=0.001]的发生；同时，与对照组比较，治疗组能够显著提高左室射血分数（LVEF）[MD=4.13，95% CI （3.62，4.64），P<0.000 01]，降低左心室舒张末期内径[MD=-3.71，95% CI （-4.37，-3.05），P<0.000 01]、降低N末端脑利钠肽前体[MD=-325.48，95% CI （-629.97，-21.00），P=0.04]，但不能改善B型脑利钠肽[MD=-185.90，95% CI （-413.12，-41.31），P=0.11]。在次要结局方面，与对照组比较，治疗组能够改善心指数、每搏输出量、左室收缩末期内径，差异具有统计学意义（P<0.05）。在不良反应方面，2组间的不良反应发生率无统计学差异（P>0.05）。结论 复方丹参滴丸联合化学药治疗能够减少冠心病PCI术后患者的主要不良心血管事件发生率、改善患者心功能，且不会增加不良反应的发生风险，安全性良好。

Objective To systematically review the effect of Compound Danshen Dropping Pills (CDDP) combined with chemical drug on adverse cardiovascular events and cardiac function for patients with coronary heart disease after percutaneous coronary intervention (PCI). Methods Randomized controlled trials (RCTs) on CDDP in the treatment for patients with coronary heart disease after PCI were searched until October 31, 2023, through eight electronic databases:The CNKI, Wanfang, VIP, SinoMed, Pubmed, Cochranelibrary, Embase, Web of Science. This study used the Cochrane Risk Test bias tool in the Cochrane Handbook to assess the quality of the methodology. Review Manager 5.4 was used to analyze the results. Results A total of 26 RCTs were ultimately selected, with a total sample size of 3384 cases, including 1 692 cases in the treatment group and 1 692 cases in the control group. The Meta-analysis revealed significant reductions in the treatment group compared to the control group for primary outcomes, including angina pectoris recurrence [RR=0.27, 95%CI (0.16, 0.45), P< 0.000 01], recurrent nonfatal myocardial infarction [RR=0.30, 95% CI (0.15, 0.60), P=0.000 7], arrhythmia [RR=0.75, 95%CI (0.62, 0.90), P=0.002], heart failure [RR=0.36, 95%CI (0.21, 0.60), P< 0.000 1], revascularization [RR=0.18, 95%CI (0.05, 0.66), P=0.01], and stent restenosis [RR=0.23, 95%CI (0.10, 0.57), P=0.001]. Compared to the control group, the treatment group significantly increased LVEF [MD=4.13, 95%CI (3.62, 4.64), P< 0.000 01], decreased LVEDD [MD=-3.71, 95%CI (-4.37,-3.05), P< 0.000 01], and reduced NT-proBNP levels [MD=-325.48, 95%CI (-629.97,-21.00), P=0.04]. However, there was no significant improvement in BNP levels [MD=-185.90, 95%CI (-413.12,-41.31), P=0.11]. Regarding secondary outcomes, the treatment group demonstrated significant improvements in CI, SV, and LVESD compared to the control group (P< 0.05). In terms of adverse reactions, there was no statistically significant difference in the incidence of adverse reactions between the two groups (P > 0.05). Conclusion The application of CDDP combined with chemical drug for the treatment of patients after PCI could reduce the occurrence of major adverse cardiovascular events (MACE), improve cardiac function in a safe and reliable manner.

R286.2；R969.3

国家青年科学基金资助项目（No.82200349）、广东省基础与应用基础研究基金面上项目（2022A1515011647）