如皋市2012-2016年5705例宫内节育器不良结局原因分析

Analysis of the Causes of Adverse Outcomes in 5705 Cases of IUD in Rugao from 2012 to 2016

目的:了解育龄妇女使用各类宫内节育器(IUD)不良结局现状。方法:对2012-2016年收集的《可疑医疗器械不良事件报告表》进行回顾性调查,核实资料的可靠性、完整性,分析各类宫内节育器不良结局的原因。结果:2012-2016年如皋市共有5705例宫内节育器不良结局案例,不良结局原因依次为意外妊娠(31.73%)、月经问题(29.27%)、位置异常(27.71%)、疼痛(10.50%)、脱落(0.32%)、其他(0.47%)。发生不良结局的IUD依次为T铜环(34.23%)、元宫环(28.97%)、宫铜环(11.10%)、其他IUD(9.57%)、爱母环(7.17)、母体乐(4.93%)、宫乐(2.03%)、吉妮环(2.00%)。T铜环、宫铜环、元宫环、母体乐、宫乐环、爱母环、其他IUD等7种IUD前三位不良结局原因均为意外妊娠、月经问题、位置异常,吉妮环为意外妊娠、月经问题和疼痛。8种IUD不良结局意外妊娠、脱落、月经问题、疼痛、位置异常、其他健康问题的上报率比较,差异均有统计学意义(P<0.05)。结论:针对IUD不良结局,开展调查研究,落实干预措施,加强质量监控。

Objective：To investigate the current situation of adverse outcomes among women of reproductive age using various intrauterine devices（IUD）.Method：A retrospective study was conducted by the《Medical Device Administration Events Report》 from 2012 to 2016,the reliability and completeness of the data were verified,and the causes of adverse outcomes were analyzed.Result：There were 5705 cases of adverse outcomes of IUD in Rugao from 2012 to 2016.The causes of the adverse events were unexpected pregnancy（31.73%）,menstrual problems（29.27%）,abnormal position（27.71%）,pain（10.50%）,fall（0.32%）,and other（0.47%）.The occurrence of adverse outcome IUD followed by Tcu-IUD（34.23%）,Yuangong-IUD（28.97%）,uterine-shaped-IUD（11.10%）,other IUD（9.57%）,MCu IUD（7.17）,Lcu IUD（4.93%）,Gongle-IUD（2.03%）and GyneFix IUD（2.00%）.The top three adverse outcomes of Tcu-IUD,uterine-shaped-IUD,Yuangong-IUD,MCu IUD,Gongle-IUD,MCu IUD and other IUD were all unexpected pregnancy,menstrual problems and abnormal position.The adverse outcomes of GyneFix IUD was unplanned pregnancy,menstrual problems,and pain.There were significant differences in the 8 IUD adverse outcomes,such as unexpected pregnancy,loss of menstruation,pain,malposition,and other health problems（P〈0.05）.Conclusion：To investigate the adverse outcomes of IUD,we should carry out investigation and research,implement intervention measures,and strengthen quality control.