中国药物警戒 ›› 2018, Vol. 15 ›› Issue (12): 728-732.

• 安全性评价与合理用药 • 上一篇    下一篇

4217例黄体酮口服制剂不良反应报告分析

胡婷霞1, 吕小琴1, 李岚2, 陶巧凤1   

  1. 1浙江省药品化妆品审评中心,浙江 杭州 310012;
    2国家食品药品监督管理总局药品评价中心,北京 100045
  • 收稿日期:2019-01-18 修回日期:2019-01-18 出版日期:2018-12-20 发布日期:2019-01-18
  • 作者简介:胡婷霞,女,硕士,工程师,中药学。

Analysis of 4217 Cases of Adverse Drug Reactions Induced by Progesterone Oral Agents

HU Tingxia1, LV Xiaoqin1, LI Lan2, TAO Qiaofeng1   

  1. 1Zhejiang Center for Drug & Cosmetic Evaluation, Zhejiang Hangzhou 310012, China;
    2Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2019-01-18 Revised:2019-01-18 Online:2018-12-20 Published:2019-01-18

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摘要： 目的 分析黄体酮口服制剂不良反应（ADR）发生特点,为临床合理用药提供依据。方法 收集2009~2017年相关企业的反馈数据和省级ADR数据库中上报的黄体酮口服制剂ADR报告4 217例,利用Excel软件进行统计并分析。结果 黄体酮口服制剂ADR多在用药当天发生,以中枢及外周神经系统损害、胃肠系统损害和全身性损害最为多见;在连续用药的情况下,有肝胆系统损害的病例报告。结论 医护人员和患者应重视黄体酮口服制剂的不良反应,特别是对神经系统的影响如头晕、眩晕、嗜睡、晕厥等;生产企业应及时修订和完善药品说明书安全性信息,确保患者用药安全。

关键词: 黄体酮口服制剂, 不良反应, 分析

Abstract: Objective To study the features of adverse drug reactions(ADRs) induced by progesterone oral agents, so as to provide rational use of drugs in clinic. Methods 4 217 cases of ADRs report caused by progesterone oral agents consisted of feedback data of related drug manufacturers and data reported by provincial ADRs monitorting system were collected from 2009 to 2017 and performed the statistical analysis by the Excel 2010 electronic form. Results Most cases of ADRs report caused by progesterone oral agents happened on the day of medication. Adverse reactions mainly included central and peripheral nervous system damage, followed by gastrointestinal system damage and systemic damage. As the extension of the duration of drug application, cases involved in hepatobiliary system damage were reported. Conclusion Hospital staff and patients should pay attention to ADRs induced by progesterone oral agents,especially for the influence of psychiatric and neurological system such as dizziness, vertigo, somnolence, syncope et al. Production enterprises should promptly revise and improve the safety information of drug instructions, so as to ensure the safety of drug use for patients.

Key words: progesterone oral agents, adverse reaction, analysis

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