中国食品药品监管Issue(12)：126-133,8.DOI:10.3969/j.issn.1673-5390.2025.12.013
基于Pareto法则的严重药品不良反应引发因素分析及应对策略
Risk Factors and Mitigation Strategies for Severe Adverse Drug Reactions Based on the Pareto Principle:Evidence from Jiangxi Province(2022-2024)
摘要
Abstract
Objective:This study aims to analyze the triggering factors of 50,653 cases of severe adverse drug reactions(ADRs)reported in Jiangxi Province from 2022 to 2024,and to provide references for scientific post-marketing drug regulation and safe clinical medication use.Methods:Utilizing the Pareto principle,statistical analyses were conducted on factors including patient age,dosage forms,drug categories,and affected organ systems,based on 50,653 severe ADRs reports.Results:Among the 50,653 severe ADR cases,patients aged≥45 years accounted for 71.95%.A total of 56,237 drug exposures were involved,with injections being the predominant dosage form(77.87%).Chemical drugs accounted for 50,154 exposures(89.18%),mainly anti-infective drugs(41.07%)and antitumor drugs(20.78%).A total of 89,470 injury events were reported,involving 27 disease systems.Disorders of the skin and subcutaneous tissues(26.13%),systemic diseases and administration-site reactions(15.68%),and gastrointestinal disorders(15.56%)were the most frequently affected.Conclusion:Based on the patterns and characteristics of severe ADRs in Jiangxi Province from 2022 to 2024,it is recommended that healthcare professionals closely monitor key risk factors associated with ADRs and strengthen ADR monitoring and clinical management.Regulatory authorities should continue to enhance post-marketing drug safety evaluations,and promptly collect and provide feedback on drug safety risk information to clinical settings,thereby jointly ensuring public medication safety.关键词
帕累托法则/严重药品不良反应/药品不良反应监测/用药安全:报告分析Key words
Pareto principle/severe adverse drug reactions/adverse drug reaction monitoring/medication safety/report analysis分类
医药卫生引用本文复制引用
LI Sui,WU Hai-bo,ZHANG Wei,ZHONG Chang-ming,LIU Yu-ting..基于Pareto法则的严重药品不良反应引发因素分析及应对策略[J].中国食品药品监管,2025,(12):126-133,8.基金项目
江西省药品监督管理局科研项目(2024GL23) （2024GL23）
