医药导报2025，Vol.44Issue(6)：982-988,7.DOI:10.3870/j.issn.1004-0781.2025.06.024
我国药品不良反应报告结构变动分析
Analysis of the Structural Changes of Adverse Drug Reaction Reports in China
摘要
Abstract
Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR)reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40%and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20)had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51)and traditional Chinese medicine category(VSV=-4.70)showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.关键词
药品不良反应报告/结构变动分析/不良反应监测/药品安全Key words
Adverse drug reaction report/Structural change analysis/Adverse drug reaction monitoring/Drug safety分类
医药卫生引用本文复制引用
黄映霓,孟光兴,李艳香..我国药品不良反应报告结构变动分析[J].医药导报,2025,44(6):982-988,7.基金项目
广东省药品监督管理局2022年科技创新项目(2022ZDZ06) （2022ZDZ06）
广东省科技厅2022年项目-国际科技合作领域"药物警戒体系下的粤港澳大湾区药品安全监管与产业协同发展问题研究". （）
