中国药物警戒 ›› 2026, Vol. 23 ›› Issue (10): 1149-1152.
DOI: 10.19803/j.1672-8629.20260516

• 安全与合理用药 • 上一篇    下一篇

更年安制剂安全性风险分析及思考

刘硕1, 柯秀琴2, 郑蕊3, 夏东胜1*   

  1. 1国家药品监督管理局药品评价中心,国家药品监督管理局监管科学创新研究基地,北京 100163;
    2宁夏药品审评查验和不良反应监测中心,宁夏 银川750004;
    3北京中医药大学中医内科学教育部和北京市重点实验室,北京 100700
  • 收稿日期:2026-06-23 出版日期:2026-10-15 发布日期:2026-10-16
  • 通讯作者: *夏东胜,女,硕士,主任药师,药品不良反应监测与上市后安全性评价。E-mail: xiadongsheng@cdr-adr.org.cn
  • 作者简介:刘硕,男,博士,助理研究员,药品不良反应监测与上市后安全性评价。
  • 基金资助:
    北京“高创计划”-青年人才托举工程（20250878）;国家药品监督管理局药品监管科学体系建设重点项目（RS2024Z008）

Safety risks of Gengnian’an preparations

Liu Shuo1, Ke Xiuqin2, Zheng Rui3, Xia Dongsheng1*   

  1. 1Center for Drug Reevaluation, NMPA/NMPA Center for Innovation and Research in Regulatory Science, Beijing 100163, China;
    2Ningxia Drug Evaluation Inspection and Adverse Reaction Monitoring Center, Yinchuan Ningxia 750004, China;
    3Ministry of Education and Beijing Key Laboratory of Internal Medicine, Beijing University of Traditional Chinese Medicine, Beijing 100700, China
  • Received:2026-06-23 Online:2026-10-15 Published:2026-10-16

PDF (PC)

38

摘要： 目的 分析更年安制剂的用药风险,为临床合理用药提供参考。方法 对国家药品不良反应监测数据库（2004年1月至2025年4月）的基本情况、累及系统-器官及临床表现、药品不良反应发生时间及转归情况,中国知网、万方数据库（建库至2026年5月1日）中更年安制剂相关不良反应进行整理与分析。结果 共纳入859例更年安制剂不良反应报告/事件,其中严重报告13例（1.51%）。不良反应主要累及胃肠（49.68%）、各类神经（16.99%）、皮肤及皮下组织（12.58%）、全身性及给药部位各种反应（6.61%）等,临床表现主要为恶心、头晕、腹泻、皮疹、呕吐、腹痛、头痛、瘙痒、腹部不适、口干、月经不调、肝损伤、肝细胞损伤、肝功能异常、黄疸等。国家药品监督管理局于2025年12月发布更年安制剂药品说明书修订公告。结论 临床使用时需警惕更年安制剂致肝损伤与异常子宫出血等风险,辨证用药;药品上市许可持有人应落实主体责任,基于真实世界数据强化其不良反应的主动监测与预警。

关键词: 更年安制剂, 肝损伤, 异常子宫出血, 安全性, 药品说明书, 药品不良反应

Abstract: Objective To analyze the safety risks associated with Gengnian’an preparations and provide a reference for rational clinical use. Methods Data on adverse drug reactions (ADR) caused by Gengnian’an preparations was collected from the National Adverse Drug Reaction Monitoring System database (between January 1, 2004 and April 30, 2025) and from such databases as China National Knowledge Infrastructure (CNKI) and Wanfang Medical Network (from inception to May 1, 2026). Results Between January 1, 2004 and April 30, 2025, a total of 859 ADR cases involving Gengnian’an preparations were reported in the National ADR Monitoring System database, including 13 serious ones (1.51%). These ADRs involved the gastrointestinal system (49.68%), nervous system (16.99%), skin and subcutaneous tissue (12.58%), and general disorders and conditions at administration sites (6.61%). Clinical manifestations included nausea, dizziness, diarrhea, rash, vomiting, abdominal pain, headache, pruritus, abdominal discomfort and dry mouth. Other reported adverse reactions included menstrual disorders, liver injury, hepatocellular injury, abnormal liver function and jaundice. In December 2025, the National Medical Products Administration (NMPA) unified the revision of package inserts for Gengnian’an preparations. Conclusion Clinicians should remain alert to the risks of liver injury, bleeding, and other hazards associated with Gengnian’an preparations, and prescribe this drug based on syndrome differentiation. Marketing authorization holders should fulfill their responsibility and strengthen proactive adverse reaction monitoring and early warning based on real-world data.

Key words: Gengnian’an Preparations, Liver Injury, Abnormal Uterine Bleeding, Safety, Package Insert, Adverse Drug Reaction (ADR)

中图分类号: