3种进口药物洗脱支架临床使用中影响患者安全的因素分析  

Analysis of influencing factors for patient safety in clinical use of three imported drug-eluting stents

作　　者：张晓燕 朱丹丹 朱永丽 张虹 王学军 ZHANG Xiao-yan;ZHU Dan-dan;ZHU Yong-li;ZHANG Hong;WANG Xue-jun(Department of Medical Engineering,Inner Mongolia People's Hospital,Hohhot 010017,China)

机构地区：[1]内蒙古自治区人民医院医学工程处,呼和浩特010017

出　　处：《医疗卫生装备》2022年第12期81-84,94,共5页Chinese Medical Equipment Journal

摘　　要：以美国食品药品监督管理局制造商和用户器械使用体验(Manufacturer and User Facility Device Experience,MAUDE)数据库上报的3种药物洗脱支架(drug eluting stent,DES)不良事件为数据来源,从病变部位情况、病变血管情况、DES及患者安全相关事件3个方面分析了进口DES临床使用中影响患者安全的风险因素,并基于不良事件形成原因对产品设计、操作人员及患者等提出了相关建议,为DES临床安全使用提供了参考。The adverse events of the three drug eluting stents(DES)reported in the Manufacturer and User Facility Device Experience(MAUDE)database of the U.S.Food and Drug Administration were used as the source of data,and the influencing factors for patient safety in the clinical use of imported DES were analyzed from three aspects of lesion site,vessel condition,DES and patient safety-related events.Some suggestions on product design,operators and patients were proposed based on the causes of adverse events,and references were provided for clinical safety of DES.

关 键 词：药物洗脱支架 临床使用 患者安全 风险因素 

分 类 号：R318.6[医药卫生—生物医学工程] TH789[医药卫生—基础医学]