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  

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

作　　者：李雅雄 王扶桑 张梅 林嘉伟 陈文戈 黄民[2] 伍俊妍[1] LI Yaxiong;WANG Fusang;ZHANG Mei;LIN Jiawei;CHEN Wenge;HUANG Min;WU Junyan(Dept.of Pharmacy,Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangzhou 510120,China;School of Pharmaceutical Sciences,Sun Yat-Sen University,Guangzhou 510275,China;Guangzhou Pinyi Information Technology Co.,Ltd.,Guangzhou 510095,China)

机构地区：[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

出　　处：《中国药房》2025年第5期606-611,共6页China Pharmacy

基　　金：广东省基础与应用基础研究基金(省企联合基金)-面上项目(No.2021A1515220154)。

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1682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。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 1682 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,bloodlymphatic 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：全面触发工具 中药配方颗粒 中药饮片 药品不良事件 药物警戒 

分 类 号：R969.3[医药卫生—药理学]