兰州大学学报（医学版）2025，Vol.51Issue(10)：61-68,8.DOI:10.13885/j.issn.2097-681X.2025.10.009
2017-2022年甘肃省药品不良反应监测报告回顾性分析
Retrospective analysis of adverse drug reaction monitoring reports in Gansu Province from 2017 to 2022
摘要
Abstract
Objective To analyze the characteristics and patterns of adverse drug reaction(ADR)in Gansu Province from 2017 to 2022,so as to provide scientific evidence and guidance for clinical medication safety.Methods A retrospective analysis was conducted on ADR monitoring data in Gansu Province(2017-2022).Statistical descriptions were performed on trends,patient demographics,severity,dosage forms,reporting sources,primary diseases,drug categories,affected organ systems,and clinical manifestations.Single-and multi-factor Logistic regression analyses were employed to investigate factors influencing the reporting of se-rious adverse drug reactions.Results Among 158 463 ADR reports,the male-to-female ratio was 1:1.32.ADR predominantly occured in middle-aged and elderly individuals(>45 years old,63.49%).New and/or severe ADR accounted for 28.92%.Injectable(66.70%)and oral formulations(31.24%)predominated.Medi-cal institutions submitted 97.30%of reports,with physicians contributing 45.21%.ADR mainly involved anti-microbial drugs(36.99%),internal medicines(14.32%),and cardiovascular agents(9.01%).Gastrointestinal(30.73%),dermatological(23.64%)and systemic/general reactions(11.77%)were most affected.Thirteen drug categories exceeded 1.00%of the reports,predominantly anti-microbials.The results of Logistic regres-sion analysis showed that female patients,those aged 1～4 years old,topical dosage forms and enterprises en-gaged in business had a lower risk of severe ADR compared to the reference group(P<0.05),while those over 45 years old and injection dosage forms were risk factors for severe ADR.Conclusion In clinical medi-cation,special attention should be paid to the monitoring of ADR in middle-aged and elderly patients,injec-tion dosage forms,and antimicrobial drugs.It is necessary to enhance the ability of clinical workers to identify and manage ADR of drugs and strengthen the education on drug safety for the public in order to reduce the occurrence of drug ADR.关键词
药品不良反应/药物警戒/甘肃省/Logistic回归分析/监测报告/风险人群/药品剂型Key words
drug adverse reaction/pharmacovigilance/Gansu Province/Logistic regression analysis/monitor-ing report/risk population/pharmaceutical dosage form分类
医药卫生引用本文复制引用
刘蓉,王雪,刘宇琴,马银霞,刘刚,吕敏,郑山..2017-2022年甘肃省药品不良反应监测报告回顾性分析[J].兰州大学学报（医学版）,2025,51(10):61-68,8.基金项目
甘肃省市场监督管理局科技计划资助项目(SSCJG-ZH-B202201) （SSCJG-ZH-B202201）
甘肃省药品监督管理局药品监管科学研究项目(2024GSMPA042) （2024GSMPA042）
