摘要
目的:分析软性角膜接触镜不良事件的特点,为用镜安全提供参考。方法:对2010年~2018年江西省药品不良反应监测中心收集的399例不良事件报告统计分析。结果:女性人数是男性的2.30倍;不良事件主要伤害表现为眼部不适、眼部病变,器械故障主要表现为镜片损坏;77位需药物治疗的配戴者未去医疗机构诊治;配戴行为不当与不良事件发生具有很强的关联性。结论:软性角膜接触镜存在较高的风险,监督管理部门需加强监督管理,保障用镜的安全。
Objective:To analyze the characteristics of medical devices adverse events of soft contact lenses,to provide reference for public safety of using.Methods:399 medical devices adverse events reports of soft contact lenses collected by Jiangxi Adverse Drug Reaction Monitoring Center from 2010 to 2018,were statistically analyzed.Results:Female were 2.30 times that of male.The main injuries of adverse events were eye discomfort symptoms,eye lesions,and,device failure was mainly manifested as lens damaged;Seventy-seven wearers needed medical treatment,did not visit the medical institution.There was a strong correlation between inappropriate wearing behavior and adverse events.Conclusion:Soft contact lenses have high risks,supervision and management departments must strengthen supervision and management to ensure the safety of lens.
作者
李穗
徐玉茗
詹杨
余超
罗培
LI Sui;XU Yu-ming;ZHAN Yang;YU Chao;LUO Pei(Jiangxi Drug Adverse Reaction Monitoring Center,Jiangxi Nanchang 330046)
出处
《中国医疗器械信息》
2020年第23期12-13,25,共3页
China Medical Device Information
基金
江西省药品监督管理局科研项目(项目编号:2019JS29)。
