中国药物警戒 ›› 2013, Vol. 10 ›› Issue (11): 679-682.

• 药械安全性研究 • 上一篇    下一篇

856例宫内节育器不良事件报告分析

王睿,王军*   

  1. 云南省药品不良反应监测中心,云南昆明 650101
  • 收稿日期:2013-01-04 修回日期:2016-03-09 出版日期:2013-11-08 发布日期:2016-03-09
  • 通讯作者: 王军,男,副主任医师,医疗器械不良事件监测。 E-mail: 630313958@qq.com
  • 作者简介:王睿,女,硕士,流行病与卫生统计学。

Analysis of 856 Adverse Event Reports Caused by Intrauterine Devices

WANG Rui Wang Jun*   

  1. Yunnan Center for ADR Monitoring, Yunnan Kunming 650101, China
  • Received:2013-01-04 Revised:2016-03-09 Online:2013-11-08 Published:2016-03-09

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摘要： 目的 对宫内节育器（IUD）不良事件报告进行分析,为安全、有效地使用IUD 和更好开展监测工作提供参考和依据。方法 对云南省2011年收集的856例涉及IUD可疑不良事件的报告进行分析。结果IUD不良事件报告主要由使用单位上报。67.6%的报告集中在四季度上报。以TCu IUD、MCu IUD、元宫型IUD 的不良事件报告数量位居前3位,分别为292 例（34.1%）、161 例（18.8%）、156 例（18.2%）。IUD 位置和形状改变、意外妊娠、月经问题的报告数量位居不良事件构成的前3 位,分别为269 例（31.5%）、240 例（28.0%）、207 例（24.2%）,其中IUD 下移242 例（28.3%）,带器妊娠238 例（27.8%）。结论进一步提高认识,积极开展IUD的不良事件监测工作,提高上报数量和质量。加强操作者的专业水平和熟练程度,预防和减少IUD的不良事件发生。

关键词: 宫内节育器, 不良事件, 器械

Abstract: Objective To provide references for the use of IUD more safely and effectively and better carry out monitoring work of medical device by analyzing the reports of Intrauterine Device(IUD) adverse events. Methods 856 cases of IUD adverse events in Yunnan province in 2011 were collected and analyzed. Results Case reports mainly came from medical facilities that used IUD. 67.6% cases were reported in the fourth quarter of 2011. The top three of IUD adverse event reports were TCu, MCu and Yuangong, which involved 292 cases(34.1%),161 cases (18.8%) and 156 cases(18.2%) respectively. The case reports of IDU position and shape change, accidental pregnancy, menstrual problems were the top three adverse events, which involved 269 cases(31.5% ), 240 cases(28.0% ) and 207 cases(24.2%) respectively, among them, IDU downward involved 242 cases(28.3%), and pregnancy with IUD involved 238 cases (27.8%).Conclusion We should enhance awareness, carry out monitoring work actively, and improve the quantity and quality of IUD adverse event reports. In order to prevent and reduce the IUD adverse events, the professional skills and proficiency level of the operators also need to be improved.

Key words: intrauterine device, adverse events, devices

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