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生物可吸收支架与药物洗脱支架治疗冠状动脉小血管病变的比较研究
作者:王烨萍  王月琴  刘文彬 
单位:福建医科大学公共卫生学院 卫生管理学系, 福建 福州 350122
关键词:生物可吸收支架 药物洗脱支架 冠状动脉小血管病变 Meta分析 
分类号:R816.2;R543.3
出版年·卷·期(页码):2022·41·第一期(26-34)
摘要:

目的:系统评价生物可吸收支架(BVS)与药物洗脱支架(DES)治疗冠状动脉小血管病变的安全性和有效性。方法:系统检索PubMed、中国知网、万方等数据库中对比BVS与DES的随机对照试验研究文献,时间跨度为2009年1月至2020年3月。根据改良Jadad量表评价文献质量。采用RevMan 5.3软件进行Meta分析。结果:最终纳入8个研究,共6 352例患者(BVS组3 582例,DES组2 770例)。Meta分析结果表明,两组支架置入后随访期内的心血管不良事件发生率、靶病变血运重建率差异有统计学意义(P=0.05、P=0.007),全因死亡率、支架内血栓形成率、心源性死亡率差异无统计学意义(P=0.07、P=0.17、P=0.90)。结论:基于目前获得的证据显示,BVS组的安全性和有效性并不显著优于DES组,但是纳入研究具有一定的偏倚风险,本研究结论需进一步严格的临床对照试验证明。

Objective: To systematically evaluate the safety and efficacy of bioresorbable vascular scaffolds(BVS) and drug-eluting stents(DES) in the treatment of coronary artery small vessel disease. Methods: PubMed, Chinese National Knowledge Infrastructure and Wanfang databases were searched to collect literature of randomized controlled trials comparing BVS and DES published from January 2009 to March 2020. The quality of the literature was evaluated according to the modified Jadad scale. Meta-analysis was performed with software RevMan 5.3. Results: Eight randomized controlled clinical trials involving 6 352 patients(3 582 cases in BVS group and 2 770 cases in DES group) were included. Meta-analysis showed that there were significant differences on major adverse cardiac events, target lesion revascularization rate(P=0.05,P=0.007), and there were not significant differences on all-cause mortality, stent thrombosis rate, cardiogenic mortality(P=0.07,P=0.17,P=0.90). Conclusion: Based on the currently available evidence, the safety and effectiveness in the BVS group are not significantly better than those in the DES group. However, the included studies have a certain risk of bias, and the conclusions of this study need further rigorously controlled clinical trials to prove.

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