中国药物警戒 ›› 2012, Vol. 9 ›› Issue (12): 748-750.

• 药械安全性研究 • 上一篇    下一篇

2666例角膜接触镜不良事件分析

欧阳黎明1, 龙丽萍2, 陈希2, 刘宁2   

  1. 1 湖南食品药品职业学院,湖南 长沙 410014；
    2 湖南省食品药品安全信息中心,湖南 长沙 410013
  • 收稿日期:2012-08-29 出版日期:2012-12-10 发布日期:2015-08-07
  • 作者简介:欧阳黎明,男,硕士,医疗器械不良事件监测及评价。

Analysis of 2 666 Cases of Adverse Events of Contact Lens

OU-YANG Li-ming1, LONG Li-ping2, CHENG Xi2, LIU Ning2   

  1. 1 Hunan Food and Drug Vocational College, Hunan Changsha 410014, China;
    2 Hunan Provincial Food and Drug Safety Information Center, Hunan Changsha 410013, China
  • Received:2012-08-29 Online:2012-12-10 Published:2015-08-07

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摘要： 目的统计分析角膜接触镜不良事件数据,为安全、有效地使用角膜接触镜,减少不良事件发生提供参考。方法采用描述性方法,使用 Excel表格对湖南2011 年上报角膜接触镜2 666例报告进行分析。结果器械生产经营企业上报的病例占总数的61.63%,监测机构上报的病例占总数的32.63%,医疗机构上报的病例占总数的4.91%,药品经营企业上报的病例占总数的0.83%,发生不良反应的男女比例为1 1.94,其中年龄21~30 岁之间发生率最高,占总病例数的58.63%。眼有异物感占不良事件主要表现的33.05%。结论合理使用角膜接触镜,降低角膜接触镜不良事件发生率。建议开展宣传培训,进一步推动医疗器械不良事件监测工作,维护公众用械安全。

关键词: 角膜接触镜, 不良事件, 分析

Abstract: ObjectiveTo provide reference for safe and effective use of contact lenses and reduce the incidence of adverse events by analyzing the data of the contact lens adverse event data. MethodsWith the description method, statistically analyze 2666 reports of contact lens collected in 2011 with the help of Microsoft Excel. ResultsThe cases reported by equipment production enterprises, monitoring bodies, medical institutions and pharmaceutical enterprises respectively accounted for 61.63%, 32.63%, 4.91% and 0.83% of the total number of items. According to the report the results, the ratio of men to women was 1:1.94, and there was the highest incidence between the ages ranged from 21 to 30 years old, accounts for 58.63% of the total number of cases. Eye foreign body sensation accounted for 33.05% of the adverse events. ConclusionIt's important to rationally use of contact lenses and reduce the incidence of contact lens adverse events. Propaganda and training were recommended to further promote the medical device adverse event monitoring and maintenance of public safety.

Key words: contact lens, adverse events, analysis