食道支架的可疑不良事件分析

摘要

目的分析总结食道支架的可疑医疗器械不良事件发生情况及问题，为进一步提高食道支架的使用安全提出建议。方法对2012年-2015年美国食品药品监督管理局 MAUDE数据库中153例食道支架有关伤害病例报告和1994年-2015年96篇涉及食道支架不良事件的国内文献进行统计分析。结果食道支架有关的伤害事件主要表现为消化道出血、断裂、胸痛、食管瘘等，构成比排名前三的是胸痛及异物感、胃食道反流和出血。结论监管部门和有关单位应加强风险责任意识，建立健全监测相关的工作制度，保障公众使用食道支架的安全。%Objective To probe into the characteristics and influencing factors of ADR cases induced by Esophageal stents, so as to provide effective resolutions for safety use. Methods By retrieving published MDR cases induced by Esophageal stents in FDA MAUDE database and CNKI database, 153 cases of adverse events in MAUDE database from 2012 to 2015 and 96 valid documents between 1994 and 2015 were obtained, screened and analyzed retrospectively. Results The main MDR performance were gastrointestinal bleeding, chest pain, foreign body sensation, etc, due to the risk inherent in the product or risk during use. Conclusion The public safety of Esophageal stents use can be ensued according to perfecting related laws, establishing and regulating the MDR monitor system and strengthening the responsibility of authority, manufacturers, suppliers and medical institutions.