麝香保心丸治疗急性心肌梗死临床疗效及安全性的Meta分析

Treatment of Acute Myocardial Infarction with Shexiang Baoxin Pill:a Meta-analysis

目的系统评价麝香保心丸联合西医常规治疗急性心肌梗死(AMI)的临床疗效及安全性,并进行证据评价。方法计算机检索中国知网(CNKI)、万方(WanFang Data)、维普(VIP)、中国生物医学文献数据库(CBM)、PubMed及Cochrane Library等数据库,收集麝香保心丸治疗AMI的随机对照试验(RCT),检索时限均为从数据库建库至2019年5月31日,由两位研究者独立按照纳入及排除标准进行文献筛选、资料提取和方法学质量评价,采用RevMan 5.3进行Meta分析,并采用GRADE工具对证据质量进行评价。结果最终纳入27个RCT,共2910例AMI病人,组间基线均可比。Meta分析结果显示:麝香保心丸联合西医常规治疗与单用西医常规治疗相比,在降低心血管事件发生率、死亡率、超敏C-反应蛋白(hs-CRP)、肌酸激酶同工酶(CK-MB)及提高左室射血分数(LVEF)方面疗效更为明显(P<0.05);不良事件发生率比较差异无统计学意义(P>0.05)。根据GRADE标准,hs-CRP为中等质量证据,心血管事件发生率、死亡率与CK-MB 3个结局指标为低质量证据,LVEF为极低质量证据。结论当前证据表明:麝香保心丸联合西医常规治疗AMI的疗效优于单用西医常规治疗,安全性较好,在降低hs-CRP方面证据可信度较高,在降低心血管事件发生率、死亡率、CK-MB及提高LVEF方面证据可信度偏低。

Objective To evaluate of the clinical efficacy and security of Shexiang Baoxin Pill combined with routine western medicine in the treatment of acute myocardial infarction(AMI).Methods CNKI,WanFang Data,VIP,CBM,PubMed,and Chorane Library were searched and the data covered the time from the establishment to May 31,2019.Randomized controlled trials(RCTs)of Shexiang Baoxin Pills in the treatment of AMI were collected.According to inclusion and exclusion criteria,the data was independently screened,extracted and methodologically quality evaluated by 2 researchers independently.Rev Man 5.3 was used to carry out meta-analysis,and GRADE profile was used to evaluate the evidence quality.Results Twenty-seven RCTs were eventually enrolled,and baselines were comparable between the trials.2910 patients with AMI were enrolled.Meta-analysis showed that Shexiang Baoxin Pill combined with routine western medicine treatment was more effective than routine western medicine treatment alone in reducing the incidence of cardiovascular events,mortality,high-sensitivity C-reactive protein(hs-CRP),creatine kinase-MB(CK-MB),and improving left ventricular ejection fraction(LVEF)(P<0.05).There was no significant difference in the incidence of adverse events between two groups.According to GRADE criteria,hs-CRP was moderate quality evidence,the incidence of cardiovascular events,mortality and CK-MB were low quality evidence,LVEF was very low quality evidence.Conclusions The efficacy of Shexiang Baoxin Pill combined with routine western medicine in the treatment of AMI is better than that of routine western medicine alone.It is high credibility in reducing the hs-CRP,and low credibility in reducing cardiovascular events,mortality,CK-MB,and improving LVEF.