中国药物警戒 ›› 2026, Vol. 23 ›› Issue (5): 564-568.
DOI: 10.19803/j.1672-8629.20260022

• 安全与合理用药 • 上一篇    下一篇

以某中药制剂为实证的真实世界药品不良反应可视化研究

魏伟1, 权勤波1, 王玲华1, 田月洁2#, 黄琳2, 李娜2, 王维波3,*   

  1. 1东营市食品药品检验研究院不良反应监测科,山东 东营 257000;
    2山东省药品不良反应监测中心,山东 济南 250014;
    3东营市人民医院药学部,山东 东营 257091
  • 收稿日期:2026-01-09 发布日期:2026-05-20
  • 通讯作者: *王维波,男,硕士,副主任药师,临床药学。E-mail: quiet12345@163.com #为共同通信作者。
  • 作者简介:魏伟,男,博士,副主任药师,药物警戒。
  • 基金资助:
    山东省药品不良反应监测哨点课题（2025SDADR-KY14）

Visualization of Real-World Adverse Drug Reaction Based on a Traditional Chinese Medicine Preparation as Empirical Evidence

WEI Wei1, QUAN Qinbo1, WANG Linghua1, TIAN Yuejie2#, HUANG Lin2, LI Na2, WANG Weibo3,*   

  1. 1Department of ADR Monitoring, Dongying Institute for Food and Drug Control, Dongying Shandong 257000, China;
    2Shandong Center for ADR Monitoring, Jinan Shandong 250014, China;
    3Department of Pharmacy, Dongying People's Hospital, Dongying Shandong 257091, China
  • Received:2026-01-09 Published:2026-05-20

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摘要： 目的 将药品不良反应（ADR）特点和联系可视化,为说明书修订、安全性研究及安全用药提供方法学参考。方法 收集山东省2020年1月1日至2024年12月31日某制剂ADR报告1 898例,利用多种信息可视化分析方法展现ADR的位置分布和联系。结果 经多种可视化图谱和数值指标确认,该制剂ADR共分为4种类型。“胃肠型”是核心集团,该集团ADR之间的联系强度远大于该集团ADR与其他集团ADR的联系强度。“过敏型”“神经型”和“心血管型”是环绕于核心集团的3个外围集团。“肝功能异常”是一个独立于各集团需特殊关注的ADR。结论 药品上市许可持有人应针对“肝功能异常”加强自主收集和信号检测,对“神经型”和“心血管型”集团中非预期ADR开展安全性研究,补充完善说明书不良反应。医疗机构可参考可视化图谱显示的ADR特点预防和处理ADR。

关键词: 中药制剂, 肝功能异常, 神经型, 心血管型, 药品不良反应, 信息可视化, 真实世界

Abstract: Objective To visualize the characteristics of and relationships between adverse drug reactions (ADR) so as to provide methodological support for revision of package inserts of drugs, safety research, and safe medication. Methods Different analytic methods for information visualization were used to display the distribution of and correlations between ADR based on 1 898 adverse reaction reports of a preparation from reports collected in Shandong Province in 2020-2024. Results As confirmed by multiple visualization maps and indicators, ADR fell into four types. Gastrointestinal ADR were the core cluster. The intragroup connections between ADR were much stronger than the intergroup ones. Allergic, neurological, and cardiovascular ADR were peripheral clusters around the core cluster. “Hepatic dysfunction” was independent of any cluster that required special attention. Conclusion Marketing authorization holders should strengthen proactive collection of ADR reports and signal detection for “hepatic dysfunction”, and conduct safety research on unexpected ADR in “neurological” and “cardiovascular” groups to improve the instructions about ADR in drugs' package inserts. Medical institutions can prevent and treat ADR according to their characteristics displayed in visualization maps.

Key words: Traditional Chinese Medicine Preparation, Hepatic Dysfunction, Neurological, Cardiovascular, Adverse Drug Reaction, Information Visualization, Real-World

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