中国药物警戒 ›› 2025, Vol. 22 ›› Issue (12): 1394-1398.
DOI: 10.19803/j.1672-8629.20250428

• 安全与合理用药 • 上一篇    下一篇

1939例老年人中成药新的不良反应报告分析

于泽胜1, 李佳2, 徐宪超1, 吕龙龙1, 王冠杰1, 刘宝生1, 张彦丽3*   

  1. 1潍坊市中医院临床药学科,山东 潍坊 261000;
    2潍坊市市场监管发展服务中心,山东 潍坊 261000;
    3北京中医药大学东方医院药学部,北京 100071
  • 收稿日期:2025-07-01 发布日期:2025-12-19
  • 通讯作者: *张彦丽,女,本科,副主任药师,临床药学。E-mail: Zyldfyy@126.com
  • 作者简介:于泽胜,男,硕士,主管药师,临床药学。
  • 基金资助:
    潍坊市科技发展计划(软科学)(2022RKX066)

Reports of New Adverse Reactions among 1939 Elders Using Chinese Patent Medicines

YU Zesheng1, LI Jia2, XU Xianchao1, LYU Longlong1, WANG Guanjie1, LIU Baosheng1, ZHANG Yanli3*   

  1. 1Clinical Pharmacy Department, Weifang Traditional Chinese Medicine Hospital, Weifang Shandong 261000, China;
    2Weifang Market Supervision and Development Service Center, Weifang Shandong 261000, China;
    3Department of Pharmacy, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100071, China
  • Received:2025-07-01 Published:2025-12-19

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摘要： 目的 分析潍坊市1 939例老年人中成药新的不良反应（ADR）发生情况,讨论老年人发生中成药ADR的影响因素,为中成药安全性监测工作提供参考。方法 收集2019年1月1日至2025年1月1日上报潍坊市药品不良反应监测中心自发呈报系统ADR报告13 553例。以60岁以上为研究对象,筛选出1 939例（14.31%）新的ADR报告,分析其性别、年龄、药品类别、给药途径、累及系统-器官及主要临床表现等。结果 老年女性发生率多于男性,主要集中在60~75岁,严重ADR男性多于女性,其中第1天发生ADR为1 212例（62.51%）。以口服最为常见（89.79%）,其次是静脉滴注（8.30%）;功效前5位为理血剂、补益剂、通络止痛、祛湿剂、蠲痹通络剂。消化系统（57.26%）和中枢及外周神经系统（11.92%）为常见新的ADR表现。结论 临床加强老年中成药的合理应用,建议医疗机构应根据老年人的不同年龄段、不同品种等针对性加强使用中成药的ADR监测,确保临床安全合理使用中成药。

关键词: 老年人, 中成药, 理血剂, 活血化瘀, 消化系统, 中枢及外周神经系统, 药品不良反应

Abstract: Objective To analyze the incidence of new adverse drug reactions (ADR) induced by Chinese patent medicines among 1 939 elderly patients in Weifang, and to identify contributors to ADR in the elderly so as to provide references for monitoring of the safety of Chinese patent medicines. Methods A total of 13 553 ADR reports submitted to the spontaneous reporting system of the Weifang Adverse Drug Reaction Monitoring Center between January 1 2019 and January 1, 2025 were collected. Patients ages 60 and older were selected as the subjects. Among them, 1 939 cases (14.31%) of new ADR were identified and analyzed in terms of gender, age, drug category, routes of administration, affected systems-organs, and major clinical manifestations. Results The incidence of new ADR was higher in elderly females than in elderly males, with the majority of cases in the group ages 60 to 75. However, severe ADR were more prevalent in males. Among the reported cases, 1 212 (62.51%) ADR occurred on the first day of medication. The most common route of administration was oral (89.79%), followed by intravenous infusion (8.30%). The top five categories of Chinese patent medicines by function were blood-regulating agents, tonifying agents, collateral-dredging and pain-relieving agents, dampness-eliminating agents, and joint-relieving and collateral-dredging agents. The most commonly affected systems were the digestive system (57.26%) and the central and peripheral nervous systems (11.92%). Conclusion Chinese patent medicines should be used more rationally in the elderly in clinical practice. It is recommended that medical institutions enhance targeted ADR monitoring based on different age groups and varieties of Chinese patent medicines to ensure safe and rational clinical use.

Key words: Elderly, Chinese Patent Medicines, Blood-Regulating Agents, Medicines Promoting Blood Circulation and Removing Stasis, Digestive System, Central and Peripheral Nervous Systems, Adverse Drug Reactions

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