Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool
- VernacularTitle: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
- Author:
Yaxiong LI
1
,
2
;
Fusang WANG
1
;
Mei ZHANG
1
;
Jiawei LIN
1
;
Wenge CHEN
3
;
Min HUANG
2
;
Junyan WU
1
Author Information
1. Dept. of Pharmacy，Sun Yat-Sen Memorial Hospital，Sun Yat-Sen University，Guangzhou 510120，China
2. School of Pharmaceutical Sciences，Sun Yat-Sen University，Guangzhou 510275，China
3. Guangzhou Pinyi Information Technology Co.，Ltd.，Guangzhou 510095，China
- Publication Type:Journal Article
- Keywords:
global trigger tool;
traditional Chinese
- From:
China Pharmacy
2025;36(5):606-611
- CountryChina
- Language:Chinese
-
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 three 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.
