中国药业2025，Vol.34Issue(18)：100-105,6.DOI:10.3969/j.issn.1006-4931.2025.18.022
基于FAERS的多奈哌齐不良事件信号挖掘
Data Mining of Adverse Drug Events for Donepezil Based on FAERS
摘要
Abstract
Objective To provide reference for the safe clinical use of donepezil.Methods The clinical use data of donepezil from the first quarter of 2019 to the fourth quarter of 2023 in the Food and Drug Administration Adverse Event Reporting System(FAERS)were extracted through the R-Studio data platform.The reporting odds ratio(ROR)method and the Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive standard method in the proportional imbalance method were used for signal mining.The medical dictionary for regulatory activities(MedDRA)was used to standardize the language of positive signals of adverse drug events(ADE),and the system organ classification(SOC)of preferred language(PT)was performed,and according to PT signal frequency and intensity were sorted and analyzed,respectively.Results A total of 6 790 cases of ADE reports with donepezil as the primary suspected drug were obtained,of which 4 336 cases were severe ADE.There was no obvious regularity in the number of ADE reported from 2019 to 2023.There was no significant gender difference in ADE patients;the majority of patients were aged 65-<85 years old;the reporters were mainly consumers,pharmacists and health experts;the most common serious ADE was hospitalization;and the majority of reports originated from the United States.A total of 400 positive ADE signals were detected.The top five PTs by frequency were fall(687 cases),death(612 cases),hallucination(474 cases),confusional state(422 cases),and product leakage issue(386 cases).Among these,12 signals were not included in the drug instructions.The top five PTs by intensity were neurogenic hypoglycemia(ROR=523.44,PRR=523.12),excessive tension(ROR=328.28,PRR=328.23),amyloid-related imaging abnormalities with edema/effusion(ROR=216.87,PRR=216.56),amyloid-related imaging abnormalities with microhemorrhage and hemosiderin deposition type(ROR=181.32,PRR=181.15),and peripheral circulatory failure(ROR=158.94,PRR=158.82),of which the top 20 signals were not included in the drug instructions.A total of 26 SOCs were involved,mainly in various nervous system disorders,general disorders and administration site conditions,and psychiatric disorders.Conclusion Clinical use of donepezil should pay attention to ADE such as neurogenic hypoglycemia,excessive tension,and focus on ADE not included in the instructions such as death,confusional state,fatigue.This study can further provide a reference for the safe use of the drug in clinical practice.关键词
多奈哌齐/美国食品和药物管理局不良事件报告系统/不良事件/数据挖掘/安全用药Key words
donepezil/Food and Drug Administration Adverse Event Reporting System/adverse drug event/data mining/drug safety分类
医药卫生引用本文复制引用
黄柳绿,许聪聪,王金亮,储锦,刘盈,韩永龙,邹欢..基于FAERS的多奈哌齐不良事件信号挖掘[J].中国药业,2025,34(18):100-105,6.基金项目
上海市第六人民医院院级回顾性临床研究课题[ynhglg202422]. （）
