中国药物警戒 ›› 2015, Vol. 12 ›› Issue (5): 305-307.

• 药械安全性研究 • 上一篇    下一篇

国内覆膜支架治疗腹主动脉瘤的有效性和安全性探讨

刘威   

  1. 国家食品药品监督管理总局医疗器械技术审评中心北京 100044
  • 收稿日期:2015-02-10 发布日期:2015-06-08
  • 作者简介:刘威,女,硕士,助理研究员,医疗器械技术审评。

Investigation of the Efficacy and Safety of Stent Graft Treatment for Abdominal Aortic Aneurysm in China

LIU Wei   

  1. Center for Medical Device Evaluation, CFDA, Beijing 100044, China
  • Received:2015-02-10 Published:2015-06-08

摘要: 目的探讨覆膜支架治疗腹主动脉瘤的有效性及安全性。方法通过“腹主动脉瘤”和“腔内隔绝术”或“支架”等关键词对万方数据库和中国期刊网、维普数据库等国内期刊数据库进行检索,对获取的数据采用定性分析的方法进行统计分析。结果符合要求的中文文献 9篇,手术成功率最低 91.35%,多数接近 100%;主要不良事件:发生率介于 1.74%~9.80%,内漏发生率在 4.65%~19.61%之间;患者 30天病死率最高 7.89%。结论覆膜支架在国内应用于腹主动脉瘤疗效相对肯定,关于并发症的评价需要更多高质量的研究进行验证。

关键词: 覆膜支架, 腹主动脉瘤, 有效性, 安全性

Abstract: Objective To investigate the efficacy and safety of stent graft treatment for abdominal aortic aneurysm in China. Methods Key words such as "abdominal aortic aneurysm" and "endovascular" or "stent" and other words were retrieved from Wangfang database and CNKI VIP database and other domestic periodicals database. Results 9 articles met with the requirements of Chinese literature, the lowest success rate of operation was 91.35%, the majority success rate were close to 100%. The incidence rates of main adverse events were between 1.74%~9.80%, the incidence of endoleak between 4.65%~19.61%, the highest mortality rate of patients in 30 days was 7.89%. Conclusion The efficacy of the stent graft in China applied to treat abdominal aortic aneurysm was relatively certain, but comments regarding the complications of stent graft to treat abdominal aortic aneurysm need more high quality research to verify.

Key words: stent graft, abdominal, aortic aneurysm, effectiveness, safety

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