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西罗莫司洗脱支架与其他冠脉支架治疗冠心病的临床安全性比较
引用本文:刘威.西罗莫司洗脱支架与其他冠脉支架治疗冠心病的临床安全性比较[J].中国药物警戒,2012,9(6):363-366.
作者姓名:刘威
作者单位:国家食品药品监督管理局医疗器械技术审评中心,北京,100044
摘    要:目的 对西罗莫司洗脱支架(SES)和其他冠脉支架治疗冠心病的临床安全性进行比较.方法 通过文献检索国内外大型数据库如pubmed、OVID medline、sciencedirect、CNKI、万方数据库等,检索近5年发表的关于SES与裸金属支架及其他药物洗脱支架术后主要心脏不良事件(MACE)、靶血管重建率和靶病变重建率等终点的对比性研究.结果 SES与裸金属支架相比,术后MACE明显下降,靶血管重建率和靶病变重建率也显著下降.SES与其他药物洗脱支架相比,临床安全性与紫杉醇洗脱支架(PES)相当,在某些患者(如合并糖尿病或冠脉分叉病变)可能优于佐他莫司洗脱支架(ZES).对于合并肾功能不全的患者,SES同样优于BES,安全性与PES相当.C反应蛋白对于SES术后发生MACE可能具有预测价值.结论 SES与裸金属支架相比,安全性明显提高,与PES相当.

关 键 词:西罗莫司洗脱支架  裸金属支架  紫杉醇洗脱支架  佐他莫司洗脱支架  主要心脏不良事件  靶血管重建率  靶病变重建率

The Clinical Safety Comparison Between Sirolimus-eluting Stent and Other Coronal Stents in Treating Coronary Artery Disease
LIU Wei.The Clinical Safety Comparison Between Sirolimus-eluting Stent and Other Coronal Stents in Treating Coronary Artery Disease[J].Chinese JOurnal of Pharmacovigilance,2012,9(6):363-366.
Authors:LIU Wei
Institution:LIU Wei (Center for Medical Device Evaluation, SFDA, Beijing 100044, China)
Abstract:Objective To compare the clinical safety of sirolimus-eluting stent(SES) and other coronary stents in treating coronary artery disease. Methods All comparision study relating to the endpoints of SES in treating coronary artery disease published in the last five years, including major adverse cardiac events(MACE), target vessel revascular- ization(TVR), target lesion revascularization(TLR.), are retrieved by indexing pubmed, OVID medline,sciencedirect, CNKI and Wanfang Data. Results Compared to bare-metal stent(BMS), the MACE of SES decreased obviously, at the same time TVR and TLIL of SES dropped in significantly too. Contrasting to other drug-eluting stents, the clinical safety of SES was equal to PES, and better than ZES in some patients who had complications of diabetes mellitus or coronary bifurcation lesions. For patients with renal inadequacy, the clinical safety of SES was better than BMS and equal to PES. Perhaps C-reactive protein had a predictive value of the MACE incidence after SES implantation. Conclusion Compared to BMS, SES preferred to show a significantly higher safety which equals to PES.
Keywords:sirolimus-eluting stent  bare-metal stent  pachtaxel-eluting stent  zotarolimus-eluting stents  major adverse cardiac events  target vessel revascularization  target lesion revascularization
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