中国药物警戒 ›› 2012, Vol. 9 ›› Issue (6): 363-366.

• 药械安全性研究 • 上一篇    下一篇

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

刘威   

  1. 国家食品药品监督管理局医疗器械技术审评中心,北京 100044
  • 收稿日期:2012-01-12 出版日期:2012-06-10 发布日期:2015-08-10
  • 作者简介:刘威,女,硕士研究生,主治医师,无源医疗器械技术评审。

The Clinical Safety Comparison Between Sirolimus-eluting Stent and Other Coronal Stents in Treating Coronary Artery Disease

LIU Wei   

  1. Center for Medical Device Evaluation, SFDA, Beijing 100044, China
  • Received:2012-01-12 Online:2012-06-10 Published:2015-08-10

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。

Abstract: Objective To compare the clinical safety of sirolimus-eluting stent(SES) and other coronary stents in treating coronary artery disease. MethodsAll 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 revascularization(TVR), target lesion revascularization(TLR), are retrieved by indexing pubmed, OVID medline,sciencedirect, CNKI and Wanfang Data. ResultsCompared to bare-metal stent(BMS), the MACE of SES decreased obviously, at the same time TVR and TLR 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. ConclusionCompared to BMS, SES preferred to show a significantly higher safety which equals to PES.

Key words: sirolimus-eluting stent, bare-metal stent, paclitaxel-eluting stent, zotarolimus-eluting stents, major adverse cardiac events, target vessel revascularization, target lesion revascularization