Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool

LI Yaxiong; WANG Fusang; ZHANG Mei; LIN Jiawei; CHEN Wenge; HUANG Min; WU Junyan

doi:10.6039/j.issn.1001-0408.2025.05.18

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Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool

更新时间：2025-09-26

- Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool
- ZHONGGUO YAOFANG Vol. 36, Issue 5, Pages: 606-611(2025)
- 作者机构：
  
  1.中山大学孙逸仙纪念医院药学部，广州　510120
  2.中山大学药学院，广州　510275
  3.广州市品毅信息科技有限公司，广州　510095
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.05.18
  CLC： R969.3
- Received：22 August 2024，
  
  Revised：2025-02-25，
  
  Accepted：26 February 2025，
  
  Published：15 March 2025
- 稿件说明：
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李雅雄,王扶桑,张梅,等.基于全面触发工具对住院患者使用中药配方颗粒及饮片不良事件的回顾性分析[J].中国药房,2025,36(05):606-611.

LI Yaxiong,WANG Fusang,ZHANG Mei,et al.Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool[J].ZHONGGUO YAOFANG,2025,36(05):606-611.
李雅雄,王扶桑,张梅,等.基于全面触发工具对住院患者使用中药配方颗粒及饮片不良事件的回顾性分析[J].中国药房,2025,36(05):606-611. DOI： 10.6039/j.issn.1001-0408.2025.05.18.

LI Yaxiong,WANG Fusang,ZHANG Mei,et al.Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool[J].ZHONGGUO YAOFANG,2025,36(05):606-611. DOI： 10.6039/j.issn.1001-0408.2025.05.18.

摘要

目的

为提高住院患者使用中药配方颗粒及饮片不良事件（ADE）的识别率提供技术支持。

方法

通过参考全面触发工具（GTT）白皮书、中药不良反应文献及专家审评意见，制定住院患者使用中药配方颗粒及饮片发生ADE的触发条目。借助GTT和中国医院药物警戒系统（CHPS）回顾性分析中山大学孙逸仙纪念医院2013年8月至2023年8月住院患者使用中药配方颗粒及饮片的ADE，评价GTT的性能并分析检出ADE的特征。

结果

该GTT共制定了48项触发条目，包括32项实验室检查指标、13项临床症状、3项解救药物。在纳入的1 682例患者中，GTT共识别潜在ADE 652例、真阳性ADE 284例，触发率为38.76%，阳性预测值为43.56%；经审查员审核，最终确认ADE 278例，ADE发生率为16.53%，明显高于同期自发呈报ADE数量（0）。278例ADE严重程度多为1级（223例），主要累及肝胆系统疾病、胃肠系统疾病、血液和淋巴系统疾病等；共涉及中药219种，使用频率高于1%的高频怀疑中药排前5位的分别为茯苓、党参、白术、炙甘草和黄芩。

结论

所建GTT可用于提高住院患者使用中药配方颗粒及饮片发生ADE的识别率。

Abstract

OBJECTIVE

To provide technical support for improving recognition rate of adverse drug events （ADEs） related to traditional Chinese medicine （TCM） formula granules and decoction pieces among inpatient patients.

METHODS

By referencing the global trigger tool （GTT） whitepaper， literature on adverse reactions to TCM， and expert review opinions， ADE trigger items for TCM formula granules and decoction pieces used in the inpatients were established. GTT was applied to analyze ADEs in inpatients who had used TCM formula granules and decoction pieces in our hospital from August 2013 to August 2023， utilizing the Chinese Hospital Pharmacovigilance System. The effectiveness of GTT and the characteristics of these ADEs were analyzed.

RESULTS

A total of forty-eight triggers were established， including thirty-two laboratory test indexes， thirteen clinical symptoms， and t

hree antidotes. Among the 1 682 patients included， GTT identified 652 potential ADEs， 284 true positive ADEs，with a trigger rate of 38.76% and a positive predictive value of 43.56%. After review by the auditor， 278 cases of ADEs were finally confirmed， with an incidence rate of 16.53%， significantly higher than the number of spontaneously reported ADEs during the same period （0）. The 278 cases of ADEs were mostly grade 1 （223 cases）， mainly involving hepatobiliary system， gastrointestinal system， blood-lymphatic system， etc；a total of 219 types of TCMs are involved，and the top five suspected TCMs used at a frequency higher than 1% were

Poria cocos

，

Codonopsis pilosula

，

Atractylodes macrocephala

， fried

Glycyrrhiza uralensis

， and

Scutellaria baicalensis

CONCLUSIONS

The established GTT can improve the recognition rate of ADEs for hospitalized patients using traditional Chinese medicine formula granules and decoction pieces.

关键词

Keywords

references

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