国产与进口雷帕霉素洗脱支架治疗应用远期安全性与有效性

背景：药物洗脱支架治疗冠状动脉粥样硬化性心脏病能有效降低术后中远期冠状动脉再狭窄和远期心脏不良事件的发生率。 目的：对比国产与进口雷帕霉素洗脱支架治疗冠状动脉粥样硬化性心脏病的安全性和有效性。 方法：按照循证医学要求全面检索国内外近5年来有关国产和进口雷帕霉素洗脱支架治疗冠状动脉粥样硬化性心脏病的随机对照或临床对照试验，对符合纳入标准的文献进行Meta分析。 结果与结论：共纳入16篇临床对照试验，其中2 603例使用国产雷帕霉素洗脱支架，2 646例使用进口雷帕霉素洗脱支架。国产雷帕霉素洗脱支架组与进口雷帕霉素洗脱支架组主要心脏不良事件、靶血管血运重建、心源性死亡、心肌梗死、支架内血栓发生率差异均无显著性意义。显示从目前临床研究看，国产雷帕霉素洗脱支架在安全性和有效性方面不亚于进口雷帕霉素洗脱支架。

Medium- and long-term efficacy and safety of domestic and imported rapamycin-eluting stents

BACKGROUND:The use of drug-eluting stents in the treatment of coronary atherosclerotic heart disease is effective in decreasing restenosis after percutaneous transluminal coronary artery angioplasty and major adverse cardiac events in medium- and long-term. OBJECTIVE:To assess the safety and efficacy of domestic and imported rapamycin-eluting stents for the treatment of coronary heart disease. METHODS:The literatures about domestic and imported rapamycin-eluting stents in the treatment of coronary heart disease are comprehensively searched in accordance with the demands of the evidence-based medicine in the last 5 years. Meta-analysis was conducted on the literatures enrolled. RESULTS AND CONCLUSION:Totally 16 controlled clinical trials were enrolled, including 2 603 casesundergoing domestic rapamycin-eluting stents and 2 646 cases undergoing imported rapamycin-eluting stents. Meta-analysis results suggested no statistical difference in major adverse cardiac events, target vessel revascularization, cardiac death, myocardial infarction, and stent thrombosis incidence between the domestic and imported rapamycin-eluting stents. It is indicated that from the present clinical trials, domestic rapamycin-eluting stents are not secondary to imported rapamycin-eluting stents in safety and efficacy.