国际生殖健康/计划生育杂志

国际生殖健康/计划生育 ›› 2012, Vol. 31 ›› Issue (3): 217-219.

• 论著 • 上一篇    下一篇

30 例T型含铜宫内节育器断裂不良事件报告分析


周定杰 ,姚 捷, 魏永越, 李 瑛   

  1. 210036 南京，江苏省计划生育科学技术研究所（周定杰，姚 捷，李 瑛）；国家人口计生委计划生育药具不良反应监测中心（周定杰，姚 捷，李 瑛）；南京医科大学公共卫生学院流行病与卫生统计学系（魏永越）
  • 收稿日期:1900-01-01 修回日期:1900-01-01 出版日期:2012-05-15 发布日期:2012-05-15
  • 通讯作者: 李 瑛

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

ZHOU Ding-jie，YAO Jie，WEI Yong-yue，LI Ying   

  1. Jiangsu Institute of Planned Parenthood Research，Nanjing 210036，China（ZHOU Ding-jie，YAO Jie，LI Ying）；NCFPC Center for Contraceptives Adverse Reactor Surveillance，Nanjing 210036，China（ZHOU Ding-jie，YAO Jie，LI Ying）；Department of Epidemiology ＆ Biostatistics，School of Public Health，Nanjing Medical University，Nanjing 210029， China（WEI Yong-yue）
  • Received:1900-01-01 Revised:1900-01-01 Published:2012-05-15 Online:2012-05-15
  • Contact: LI Ying

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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。

关键词: 宫内避孕器, 铜, 断裂, 不良反应, 严重伤害事件

Abstract: 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（IC=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.

Key words: Intrauterine devices, copper, Breakage, Adverse event, Serious injury event