目的对速效救心丸治疗急性冠脉综合征的临床疗效和安全性进行系统评价。方法电子文献检索:中文数据库包括中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、中国生物医学文献光盘数据库(CBM);外文数据库包括Pub Med、Cochrane Library。筛选合格研究,进行文献质量评价,运用异质性检验、Meta分析、敏感性分析等方法统计相关数据。结果纳入15项研究,文献质量偏低;统计分析结果显示,速效救心丸能够改善急性冠脉综合征的中医证候[RR=1.26,95%,CI(1.08-1.49),P〈0.01],提高心绞痛[RR=1.24,95%,CI(1.11-1.38),P〈0.01]和心电图疗效[RR=1.25,95%,CI(1.12-1.40),P〈0.01],降低急性冠脉综合征患者的血清超敏C反应蛋白(hs-CRP)水平(P〈0.05)。结论急性冠脉综合征患者应用速效救心丸安全有效,较单纯常规治疗可进一步提高临床疗效,可靠的结论需期待更多高质量的多中心随机双盲对照试验证据,尤其是对于长期预后影响的研究。
Objective: To evaluate the clinical curative effect and safety of Suxiao Jiuxin Pill on acute coronary syndrome with Meta-analysis. Methods: CNKI,VIP,CBM,Pub Med,the Cochrane Library and other relevant databases were electronically searched. Qualified researches were selected,and the quality of literature was evaluated. The data was analysed by the heterogeneity test,meta analysis and sensitivity analysis,et. Results: Total 15 RCTs with poor general quality were included. Results of meta-analyses showed that compared with the routine WM treatment group,additional use of Suxiao Jiuxin Pill could improve the TCM syndrome efficacy [RR =1.26,95%,CI(1.08-1.49),P〈 0.01],the angina symptoms [RR =1.24,95%,CI(1.11-1.38),P〈 0.01] and ECG efficacy [RR=1.25,95%,CI(1.12-1.40),P〈 0.01],and decrease the level of hs-CRP(P〈 0.05). Conclusion:Suxiao Jiuxin Pill is effective and safe in the treatment of acute coronary syndrome. However,rigorous design and large sample randomized double-blind controlled trial are still needed to verify and support its clinical effectiveness,especially in the research on the effects of long-term prognosis.