中国药物警戒 ›› 2016, Vol. 13 ›› Issue (5): 295-297.

• 安全性评估与合理用药 • 上一篇    下一篇

156例左炔诺孕酮宫内节育系统药品不良反应/医疗器械不良事件分析

张敏,孙志明,许豪勤,杨月华,   

  1. 江苏省计划生育科学技术研究所，国家人口计生委计划生育不良反应监测中心，江苏 南京 210036
  • 收稿日期:2016-01-04 修回日期:2016-06-30 出版日期:2016-05-20 发布日期:2016-06-30
  • 通讯作者: 许豪勤，女，研究员，计划生育药具不良反应监测。E-mail:1325825613@qq.com
  • 作者简介:张敏，女，硕士，助理研究员，计划生育药具不良反应监测。

Analysis of 156 Cases of Adverse Drug Reactions/Medical Device Events Induced by Levonorgestrel-releasing Intrauterine System

ZHANG Min, SUN Zhi-ming, XU Hao-qin, YANG Yue-hua   

  1. Jiangsu Institute of Planned Parenthood Research, NPFPC Center for Contraceptives Adverse Reaction Surveillance, Jiangsu Nanjing 210036, China
  • Received:2016-01-04 Revised:2016-06-30 Online:2016-05-20 Published:2016-06-30

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摘要： 目的 了解左炔诺孕酮宫内节育系统相关药品不良反应（ADR）/医疗器械不良事件（MDE）表现及特点，对临床规范使用左炔诺孕酮宫内节育系统，减少育龄妇女副反应及不良反应提供参考。方法 对国家人口计生委计划生育药具不良反应监测中心避孕药品及器械的数据库中156例关于左炔诺孕酮宫内节育系统的报告进行回顾性分析，对ADR/MDE的年龄、时间分布及表现等进行探讨。结果156例ADR/MDE报告中只有6例来源于避孕药品的ADR库；126例左炔诺孕酮宫内节育系统是在医院放置，占81.29%；ADR/MDE中月经问题85例，占54.49%，其中闭经有31例，占36.47%。结论 左炔诺孕酮宫内节育系统的主要ADR/MDE是月经问题。左炔诺孕酮宫内节育系统的放置机构主要是医院，医生的推荐对曼月乐的使用有着重要作用，放置前应做好充分的知情同意。LNG-IUS具有药品和器械的特点，若发生药品相关的终止取出，既要上报药品的不良反应报告，也要上报器械的不良事件报告。

关键词: 左炔诺孕酮宫内节育系统, 药品不良反应, 医疗器械不良事件, 分析

Abstract: Objective To explore the characteristics of adverse drug reactions（ADRs）/medical device events（MDEs）caused by the levonorgestrel-releasing intrauterine system (LNG-IUS). Methods 156 cases of ADRs/MDEs caused by LNG-IUS were analyzed via retrospective study in terms of ages, time distribution and manifestation. Results The LNG-IUS was mainly placed in hospital, 85 cases were menstruproblems (54.49%), of which 31 cases were absence of menstruation (36.47%). Conclusion The most information on LNG-IUS was from hospital and doctor. Recommendation of doctor was important for using LNG-IUS. The main ADR/MDE of LNG-IUS was the change of menstruation. Informed consent should be done before using LNG-IUS. The LNG-IUS has the characteristics of drug and medical device, once taken out because of the drug, both ADR and MDE reports should be sabmitted.

Key words: levonorgestrel-releasing intrauterine system (LNG-IUS), adverse drug reaction, medical device event, analysis

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