昆明医科大学学报2025，Vol.46Issue(1)：16-22,7.DOI:10.12259/j.issn.2095-610X.S20250103
基于FAERS数据库的阿奇霉素不良事件的信号挖掘与分析
Signal Mining and Analysis of Adverse Events of Azithromycin Based FAERS Database
摘要
Abstract
Objective To explore and analyze adverse drug events(ADE)signals of azithromycin,identify common adverse events and suspected adverse reactions that occur easily in the real clinical application of azithromycin.Methods The adverse drug event reports related to azithromycin recorded in the US FDA Adverse Event Reporting System database from October 1,2003,to October 1,2023,were mined using the OpenVigil 2.1 drug surveillance platform.Signal detection and analysis were carried out using the reporting odds ratio(ROR)and Bayesian confidence propagation neural network method(BCPNN).Results A total of 5498 ADE signals were identified,with a total of 112485 reports.Eventually,31,041 azithromycin-associated adverse event reports were extracted,involving 898 positive signals,27 system organ classes,mainly concentrated in respiratory system diseases,infections,gastrointestinal system diseases,and others.Additionally,some adverse reactions possibly caused by azithromycin were discovered,such as asthma,wheezing,and potential reactions like incomplete abortion.Conclusion When using azithromycin,besides paying attention to the adverse reactions listed in the drug instructions,we should also pay attention to some adverse reactions that have not been timely recorded or updated,in order to prevent the medication safety risks caused by outdated instructions,provide reasonable medication advice,and ensure the medication safety of patients.关键词
阿奇霉素/药品不良事件/FDA不良事件报告系统/数据挖掘和分析Key words
Azithromycin/Adverse drug events/FDA adverse event reporting system/Data mining and analysis data mining分类
医药卫生引用本文复制引用
彭青兰,罗佳露,余佳仪,汪凯鑫,吴芳,许传志..基于FAERS数据库的阿奇霉素不良事件的信号挖掘与分析[J].昆明医科大学学报,2025,46(1):16-22,7.基金项目
云南省科技厅基础研究计划(202301AY070001-292) （202301AY070001-292）
三峡大学横向课题(SDHZ20240043) （SDHZ20240043）
