苦碟子注射液治疗不稳定性心绞痛随机对照试验系统评价

Systematic Review of Randomized Controlled Trials of Kudiezi Injection on Unstable Angina Pectoris

目的:系统评价苦碟子注射液治疗不稳定性心绞痛的有效性和安全性。方法:检索The Cochrane Library、PubMed、CNKI数据库、万方数据知识服务平台、中国生物医学文献数据库,搜集苦碟子注射液治疗不稳定性心绞痛的随机对照试验,按照Cochrane协作网推荐的方法评价纳入研究的方法学质量,提取相关数据,运用RevMan5.2软件完成异质性检验、Meta分析、敏感性分析、倒漏斗图分析等相关统计分析。结果:共纳入12项合格研究,共计1 114例患者,纳入研究方法学质量普遍较低,研究间具有异质性,Meta分析结果显示苦碟子注射液在提高不稳定性心绞痛的临床疗效方面合并效应量RR=1.25,95%CI[1.16,1.34],在改善不稳定性心绞痛的心电图表现方面合并效应量RR=1.33,95%CI[1.19,1.49],结果均具有统计学意义;敏感性分析提示结果稳定;倒漏斗图分析显示不对称;未见苦碟子注射液的不良反应报道。结论:联用苦碟子注射液治疗不稳定性心绞痛可提高临床疗效,改善心电图表现,且较为安全,但由于纳入研究的质量较低,尚需要开展样本量充足、设计合理、执行严格的临床试验以提供更加真实可靠的证据。

Objective：To systematically assess the efficacy and safety of Kudiezi Injection on unstable angina pectoris. Method ： Randomized controlled trials of Kudiezi Injection on unstable angina pectoris were retrieved from The Cochrane Library, PuhMed, CNKI, Wanfang database and CBM. The methodological quality of included studies was assessed according to the criteria recommended by the Cochrane Handbook for Systematic Reviews of interventions. Such statistical analyses as heterogeneity analysis, Meta-analyses, sensitivity analyses and funnel plot analyses were performed using the Review Manager 5.2 software. Resuhs ： Twelve qualified trials involving 1 1 14 participants were included. The methodological quality was generally low and heterogeneity existed among them. Met-analyses showed that Kudiezi Injection can improve the clinical efficacy （RR=l.25,95%CI[1.16,1.34]）and ECG manifestations （RR=l.33, 95%C1[1.19,1.4.9] ）with no adverse reaction reported. Funnel plot was asymmetry. Conclusion： Current evidence indicates that treating unstable angina, pectoris with Kudiezi Injection can improve the clinical efficacy and ECG manifestations. Due to the low quality of included studies, clinical trials with adequate samples, rational design and strict execution should be carried out to provide more reliable evidence.