注射用红花黄色素治疗稳定型劳累性心绞痛疗效的系统评价

目的:系统评价注射用红花黄色素(safflor yellow injection,SYI)在大样本、扣除多中心疗效变异时,治疗稳定型劳累性心绞痛不同症状的有效性。方法:收集4个多中心临床试验资料,试验由26个分中心完成,结果不完全一致,将每个分中心试验作为一个独立研究,根据筛选标准,选择合适的25个分中心资料(总病例数1242例,试验组787例,对照组455例)作为Meta分析的合并对象,并对纳入研究的质量进行评价。计数资料采用相对危险度(RR)、计量资料采用加权均数差值(WMD)进行合并分析。发表偏倚以失效安全数(Nfs)进行分析。结果:SYI治疗稳定型劳累性心绞痛的疗效均优于对照组,包括胸痛疗效(RR合并=1.25,95%CI 1.12~1.39),胸闷疗效(RR合并=1.14,95%CI 1.06~1.22),心悸疗效(RR合并=1.13,95%CI 1.04~1.22),症状综合疗效(RR合并=1.21,95%CI 1.13~1.31),症状总积分下降值[WMD合并=0.83,95%CI为(0.55,1.12)]。单项症状胸痛、胸闷、心悸改善的有效率分别为60%、77.7%、73.0%,症状综合疗效有...

Effectiveness of safflor yellow injection in the treatment for stable angina pectoris: a systematic review

AIM: To review the effectiveness of the safflor yellow injection(SYI) in the treatment for stable angina pectoris under the condition of large sample and deduction of multicentre effectiveness variation.METHODS: Four multicenter clinical trials(completed by 34 sub-centers with different efficacy) were collected.Each sub-center clinical trial was regarded as an independent study.According to our criteria,25 suitable sub-centers were identified.A total of 1242 participants(787 participants in treatment group and 455 subjects in control group)were analyzed by Meta-analysis.Quality of included trials was assessed.Relative risk(RR) was used for the analysis of dichotomous outcomes,and the weighted mean difference(WMD) for continuous outcomes.Analysis of publication bias was shown with Fail-Safe number(Nfs).RESULTS: The effectiveness of SYI in treating stable angina pectoris were superior to control group,such as the efficacy of chest pain with pooled RR 1.25 and 95%CI 1.12 to 1.39,the chest distress with pooled RR 1.14 and 95%CI 1.06 to 1.22,the cardiopalmus with pooled RR 1.13,95%CI 1.04 to 1.22,the effective rate of total scores of symptoms with pooled RR 1.21,and 95%CI 1.13 to 1.31,and the decrease of total scores of symptoms with pooled WMD 0.83 and 95%CI 0.55 to 1.12.The effective rates of chest pain,chest distress and cardiopalmus are 60%,77.7% and 73.0%,respectively.It was 81.7% in total scores of symptoms.Fail-Safe number showed that the publication bias was not significant and the results were reliable.CONCLUSION: SYI is an effective agent for stable angina pectoris.This study also shows that if the result from each sub-center clinical trial is quite different or opposite,Meta-analysis can make decision about efficacy in multicentre clinical trial.