丹参川芎嗪注射液治疗冠心病心绞痛系统评价

摘要

Objective To systematically evaluate the clinical efficacy and safety of Danshen Chuanxiongqin Injection (DCI) in the treatment of angina pectoris. Methods Randomized controlled trials (RCTs) regarding DCI in the treatment of angina pectoris were searched in CNKI, VIP, Wanfang Database, CBM, PubMed, Embase and Cochrane Library by Feb. 2014. Two researchers independently retrieved the RCTs and extracted the information. The Cochrane risk of bias method was used to assess the quality of the included studies, and a meta-analysis was conducted with Review Manager 5.2 software. Results A total of 12 RCTs with 1145 participants were included. The meta-analysis indicated that the combined use of DCI and conventional treatment with western medicine was more effective in the outcomes of the total clinical effective rate [RR=1.27, 95%CI (1.19,1.35), P<0.000 01], the total effective rate of ECG [RR=1.34, 95%CI (1.23,1.46), P<0.000 01], and decrease of plasma viscosity [MD=-0.15, 95%CI (-0.25,-0.05), P=0.004] and fibrinogen [MD=-0.96, 95%CI (-1.14,-0.78), P<0.000 01]. And there were no adverse drug reaction reports. Conclusion Based on this systematic evaluation, DCI combined with conventional therapy is effective and relatively safe in treating angina pectoris, but it still needs larger samples, multi-center, and high quality RCT to verify.%目的：系统评价丹参川芎嗪注射液用于治疗冠心病心绞痛的有效性及安全性。方法全面系统地检索中国知识资源总库(CNKI)、中文科技期刊数据库(VIP)、中国学术期刊数据库(万方数据)、中国生物医学文献数据库(CBM)、PubMed、Embase和Cochrane Library等数据库,检索时间2014年2月,获得符合纳入标准的随机及半随机临床对照试验。2名研究者独立采用Cochrane风险评价表评价其研究质量,并提取所需资料,采用RevMan5.2软件进行Meta分析。结果共纳入12篇文献,共计受试者1145例。Meta分析结果显示,丹参川芎嗪注射液联合西医常规疗法治疗冠心病心绞痛具有较好疗效,临床总有效率[RR＝1.27,95%CI(1.19,1.35), P＜0.00001]、改善心电图总有效率[RR＝1.34,95%CI(1.23,1.46),P＜0.00001]优于对照组,且能更好地降低血浆黏度[MD＝-0.15,95%CI(-0.25,-0.05),P＝0.004]、纤维蛋白原[MD＝-0.96,95%CI(-1.14,-0.78),P＜0.00001]等。临床未见不良反应报告。结论丹参川芎嗪注射液用于治疗冠心病心绞痛具有一定的疗效且相对安全,但仍需进行大样本、多中心、高质量的临床随机对照试验进一步验证。