红花黄色素治疗稳定型心绞痛疗效的Meta分析

Meta-analysis of Safflower Yellow Injection for the Treatment of Stable Angina Pectoris

目的系统评价红花黄色素治疗稳定型心绞痛的临床疗效和安全性。方法通过全面检索与红花黄色素治疗稳定型心绞痛相关的随机对照临床试验研究文献,运用Cochrane图书馆系统评价方法,对纳入的文献进行质量评价及Meta分析。结果 13个随机对照试验纳入系统评价,包含了3024例患者。Meta分析结果显示:红花黄色素注射液组对心绞痛症状总体疗效显著优于对照组,差异有统计学意义(OR=2.69,95%CI(1.95,3.70),P<0.01);对中医症候疗效(OR=2.73,95%CI(2.20,3.38),P<0.01)及心电图情况的改善方面(OR=1.72,95%CI(1.31,2.25),P<0.01),试验组亦显著优于对照组。结论红花黄色素注射液治疗稳定型心绞痛在临床症状、中医症候、心电图改善方面疗效确切,而不良反应与对照组比较没有明显差别,安全性较好。但受纳入文献的质量限制及可能存在的发表性偏倚,本结论仍需更多多中心、大样本的随机双盲对照实验进一步证实。

OBJECTIVE To evaluate the efficacy and safety of Safflower Yellow Injection（SYI） in the treatment of Stable Angina Pectoris（SAP）. METHODS Randomized controlled trials（RCTs） on the efficacy and safety of SYI in treating patients with SAP were retrieved in the following databases as CNKI,Wan Fang Data,Pubmed et al. The literature which met the inclusion and exclusion criteria were selected,data were extracted,the quality was evaluated,and meta-analysis was performed by using Rev Man 5. 0 software. RESULTS A total of 13 RCTs involving2612 patients were included. The meta-analysis showed that,compared with the control group,SYI was significantly superior in the following 3 aspects： the efficacy on Angina（OR = 2. 69,95% CI（1. 95,3. 70）,P〈0. 01）,the total effect on TCM Symptoms（OR = 2. 73,95% CI（2. 20,3. 38）,P〈0. 01）,and the efficacy on ECG（OR = 1. 72,95%CI（1. 31,2. 25）,P〈0. 01）. CONCLUSION Based on current studies,SYI is superior to other medicines in the control group for SAP at present,and it has no significant difference in side effects compared with the control group,so it is regarded as an effective and safe drug. For the quality restrictions and possible publication bias of the included studies,this conclusion needs to be confirmed by more high quality,large sample,muiti-center,double blind RCTs.