心脏血管内支架常见风险因素分析  

Analysis on the Common Risk Factors of Coronary Stent

作　　者：周定杰[1,2] 赵燕[3] 周晶鑫 

机构地区：[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

出　　处：《中国药物警戒》2012年第12期740-744,共5页Chinese Journal of Pharmacovigilance

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。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.

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 

分 类 号：R197.39[医药卫生—卫生事业管理]