速效救心丸治疗急性冠状动脉综合征疗效和安全性的系统评价

A systematic review of the efficacy and safety of Suxiao Jiuxin Pill in the treatment of acute coronary syndrome

关键词:  速效救心丸  急性冠状动脉综合征  临床终点事件发生率  随机对照试验  系统评价  Meta分析

Key words:  Suxiao Jiuxin Pill  acute coronary syndrome  incidence of clinical endpoint events  randomized controlled trial  systematic review  Meta-analysis

摘要:

[目的] 系统评价速效救心丸治疗急性冠状动脉综合征（ACS）的疗效和安全性。[方法] 计算机检索MEDLINE、EMbase、Cochrane Library、中国知网数据库（CNKI）、维普数据库（VIP）和万方数据库（WanFang Data）等，纳入速效救心丸联合常规西药（治疗组）与单纯常规西药（对照组）对比治疗ACS的随机对照试验（RCT），检索时限均为从2009年1月1日—2019年7月15日。由两位评价者独立筛选文献、提取资料和评价纳入研究的偏倚风险后，采用RevMan 5.3软件进行Meta分析。[结果] 最终纳入11个RCT，共1 296例ACS患者。Meta分析结果显示：治疗组的临床终点事件发生率[RR=0.43，95% CI（0.29，0.64），P<0.000 1]显著低于对照组，临床总有效率[RR=1.19，95% CI（1.12，1.26），P<0.000 01]和心电图疗效[RR=1.29，95% CI（1.14，1.46），P<0.000 1]均显著高于对照组，且差异有统计学意义；在C反应蛋白（CRP）[SMD=-0.55，95% CI（-1.09，-0.01），P=0.05]和不良反应发生率[RR=1.68，95% CI（0.09，30.38），P=0.73]方面，两组差异无统计学意义。[结论] 当前证据显示，速效救心丸联合常规西药治疗能有效缓解ACS患者的临床症状、改善心电图疗效和降低临床终点事件的发生率，且安全性较好。受纳入研究质量和数量所限，上述结论仍需更多高质量的RCT加以验证。

Abstract:

[Objective] To systematically evaluate the efficacy and safety of Suxiao Jiuxin Pill in the treatment of acute coronary syndrome.[Methods] The MEDLINE,EMbase,Cochrane Library,CNKI,VIP and WanFang Data were searched by computer. The randomized controlled trial (RCT) of Suxiao Jiuxin Pill combined with conventional Western medicine (treatment group) and simple conventional Western medicine (control group) in the treatment of acute coronary syndrome was included. The search time was from January 1,2009 to July 15,2019. Two evaluators independently screened the literature,extracted the data and evaluated the bias risk included in the study,and then used RevMan 5.3 software for Meta-analysis.[Results] Eleven RCTs were finally included,with a total of 1 296 patients with acute coronary syndrome. Meta-analysis showed that the incidence of clinical endpoint events in the treatment group[RR=0.29,95%CI (0.17,0.51),P<0.000 1] was significantly lower than that in the control group,and the total clinical effective rate[RR=1.19,95%CI(1.12,1.26),P<0.000 01] and electrocardiogram curative effect[RR=1.29,95%CI(1.14,1.46),P<0.000 1] were significantly higher than those of the control group,and the difference was statistically significant. There was no significant difference in CRP[SMD=-0.55,95%CI(-1.09,-0.01),P=0.05] and incidence of adverse reactions[RR=1.68,95%CI(0.09,30.38),P=0.73] between two groups.[Conclusion] The current evidence shows that Suxiao Jiuxin Pill combined with conventional western medicine can effectively alleviate the clinical symptoms of patients with acute coronary syndrome,improve the efficacy of electrocardiogram and reduce the incidence of clinical endpoint events,and it is safe. Limited by the quality and quantity of the included studies,the above conclusions still need to be verified by more high-quality randomized controlled trials.