30例T型含铜宫内节育器断裂不良事件报告分析  

Analysis on the Adverse Events of Copper-T IUD Breakage of 30 Cases

作　　者：周定杰[1,2] 姚捷[1,2] 魏永越[3] 李瑛[1,2] 

机构地区：[1]江苏省计划生育科学技术研究所,南京210036 [2]国家人口计生委计划生育药具不良反应监测中心 [3]南京医科大学公共卫生学院流行病与卫生统计学系

出　　处：《国际生殖健康／计划生育杂志》2012年第3期217-219,共3页Journal of International Reproductive Health/Family Planning

基　　金：中央财政专项"避孕药具不良反应监测与防治";"十一五"国家科技支撑计划课题"避孕药具上市后监测和风险再评价研究"(2006BAI15B07);江苏省科技厅项目"江苏避孕药具上市后监测与风险评价业务建设"(BM2009904)

摘　　要：目的:了解T型含铜宫内节育器(IUD)断裂不良事件的情况。方法:收集国家人口计生委计划生育药具不良反应监测中心自2005年10月—2010年11月全国105个试点上报的T型含铜IUD(TCu380A/TCu220C)断裂不良事件报告共计30例,对事件进行因果关系分析和关联性评价,探索其相关影响因素,为其防治提供依据。结果:30例断裂事件中涉及TCu380A 4例,TCu220C 26例。其中28例断裂部位发生在横臂,2例发生在纵臂。B企业生产的TCu220C发生断裂事件的比例高于A企业(信息成分IC=0.40,95%CI下限=0.02)。结论:建议加强对B企业的TCu220C上市后安全性监测。计划生育技术服务人员应重视IUD断裂事件,加强置器后随访服务,发现问题及时处理,并报告IUD严重伤害事件,减少其对育龄妇女健康的危害。Objective： To evaluate the adverse events of the copper-T Intrauterine device （IUD） breakage, so as to explore the relative factors. Methods： A total of 30 cases of the breakage adverse events related to copper-T IUD were collected from 105 contraceptive adverse reaction surveillance sentinels from October 2005 to November 2010. All of these cases were analyzed by the method of causality assessment. Results： There were 4 TCu380A cases and 26 TCu220C cases in 30 cases. The fracture parts were cross arms in 28 cases and trailing arms in others. The breakage constituent ratio of TCu220C from B enterprise was higher than that from A enterprise （1C=0.40, lower limit of 95%CI=0.02）. Conclusions： The postmarked surveillance of TCu220C from B enterprise should be strengthened. The professional staff of family planning should pay attention to the adverse events of copper-T IUD breakage. To prevent the serious injury events, it is key to keep up the follow-up visit system after insertion. The adverse events should be treated timely, and the serious injury event should be reported immediately.

关 键 词：宫内避孕器 铜 断裂 不良反应 严重伤害事件 

分 类 号：R169.4[医药卫生—公共卫生与预防医学]