中国药物警戒 ›› 2012, Vol. 9 ›› Issue (12): 740-744.

• 药械安全性研究 • 上一篇    下一篇

心脏血管内支架常见风险因素分析

周定杰1,2, 赵燕3*, 周晶鑫4   

  1. 1 江苏省计划生育科学技术研究所,江苏 南京 210036；
    2 国家人口计生委计划生育药具不良反应监测中心,江苏 南京 210036；
    3 国家食品药品监督管理局药品评价中心,北京 100045；
    4 哈尔滨市药品不良反应监测中心,黑龙江 哈尔滨 150016
  • 收稿日期:2012-08-29 出版日期:2012-12-10 发布日期:2015-08-07
  • 通讯作者: 赵燕,硕士,医疗器械不良事件监测与评价。E-mail:zhaoyan@cdr.gov.cn
  • 作者简介:周定杰,男,硕士,医疗器械不良事件监测与评价、临床医学。

Analysis on the Common Risk Factors of Coronary Stent

ZHOU Ding-jie1, 2, ZHAO Yan3*, ZHOU Jing-xin4   

  1. 1 Jiangsu Institute of Planned Parenthood Research, Jiangsu Nanjing 210036, China;
    2 NCFPC Center for Contraceptives Adverse Reactor Surveillance, Jiangsu Nanjing 210036, China;
    3 Center for Drug Reevaluation, SFDA, Beijing 100045, China;
    4 Harbin Center for ADR Monitoring, Heilongjiang Harbin 150016, China
  • Received:2012-08-29 Online:2012-12-10 Published:2015-08-07

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摘要： 目的探讨心脏血管内支架不良事件风险点,提出风险控制措施。方法收集国内文献中有关心脏血管内支架可疑不良事件108例进行回顾性分析。结果心脏血管内支架不良事件主要伤害可分为3类：①术中或术后的继发疾病;②植入过程中或植入后支架本身出现异常;③支架植入后患者各种不适症状和体征异常。最常见的事件后果为需要内、外科治疗避免机体结构永久损伤。结论支架内血栓是伤害后果最严重的风险点。支架内再狭窄是心脏血管内支架最常见的风险点。需要生产企业、医疗机构和监管部门共同采取措施减少心脏血管内支架产品的临床使用风险。

关键词: 经皮冠状动脉介入治疗, 心脏血管内支架, 医疗器械不良事件, 支架内血栓, 支架内再狭窄

Abstract: Objective To explore the risk point of coronary stent adverse events and offer the risk control measures respectively. Methods A total of 108 cases of coronary stent adverse events were collected from the domestic literature and analyzed retrospectively. Results The primary lesions of coronary stent adverse events were grouped into three categories: the intraoperative and postoperative secondary diseases, the device operated differently than expected or device malfunction, the signs and symptoms after stent implanted. The most common event consequence was needed for internal, surgical treatment to avoid permanent damage to the body structure. Conclusion The injury of stent thrombosis was the most severe and the in-stent restenosis was the most common risk point in all of the coronary stent adverse events. The control measures should be taken at same time by the manufacturing enterprises of medical device, the medical institutions and the supervision departments to decrease the risk of coronary stent in clinic.

Key words: percutaneous coronary intervention, coronary stent, medical device adverse event, stent thrombosis, in-stent restenosis