基于Meta分析的红花注射液治疗不稳定型心绞痛临床评价研究

Meta-analysis on the Randomized Controlled Trials of Safflower Injection in the Treatment of Unstable Angina Pectoris

目的:运用Meta分析方法评价红花注射液联合西医常规治疗不稳定型心绞痛的临床疗效及安全性。方法:系统检索Embase、Pub Med、the Cochrane Library、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、中国生物医学文献数据库(Sino Med)、万方数据库,检索时间从各数据库建库至2016年6月1日,全面搜集红花注射液联合西医常规治疗不稳定型心绞痛的随机对照试验,对纳入文献进行质量评价,提取资料并通过Rev Man 5.3软件进行数据分析。结果:共纳入9篇文献,累计876例受试者。Meta分析结果显示:在常规用药的基础上,联合使用红花注射液可提高心绞痛疗效(RR=1.31,95%CI:1.22~1.40,P<0.000 01)和心电图疗效(RR=1.40,95%CI:1.24~1.59,P<0.000 01);但红花注射液不能明显改善不稳定型心绞痛患者的血浆黏度。仅4篇文献记录了药品不良反应发生情况,未发生严重不良反应。结论:在西医常规治疗的基础上联合使用红花注射液对不稳定型心绞痛有较好的疗效,但其安全性仍需进一步探讨。

Objective：To systematically evaluate the clinical effectiveness and safety of Safflower injection combined with conventional therapy in the treatment of unstable angina pectoris （UAP）. Methods： According to literature databases, we conducted a thorough and systematic retrieval of randomized controlled trials （RCTs） which regarding Safflower injection for treating UAP. The Cochrane Risk of Bias Assessment Table was used to evaluate the methodological quality of the RCTs and then the data were extracted and Meta-analysed by RevMan 5.3 software. Results： A total of 9 RCTs with 876 participants were included. In the Meta-analysis, the combining use of Safflower injection and conventional therapy in the treatment of UAP can achieve a higher angina pectoris curative effect （RR = 1.31, 95% CI： 1.22-1.40, P 〈 0.000 01）, and the electrocardiogram curative effect （RR = 1.40, 95% CI： 1.24-1.59, P 〈0.000 01 ）. Furthermore, Safflower injection can not reduce plasma viscosity significantly. And there was no major or serious adverse drug event. Conclusion：Safflower injection combined with conventional therapy had good therapeutic effect on unstable angina pectoris （UAP）. Drug safety should be confirmed by more well-designed and large-scale RCTs.