首页|基于FAERS数据库的阿奇霉素不良事件的信号挖掘与分析

基于FAERS数据库的阿奇霉素不良事件的信号挖掘与分析

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目的 挖掘和分析阿奇霉素的不良事件(ADE)信号,发现阿奇霉素临床真实应用中容易出现的不良事件及可疑不良反应.方法 采用OpenVigil 2.1 药物警戒平台挖掘美国FDA不良事件报告系统数据库中2003 年 10 月 1 日至 2023 年 10 月 1 日内收录的与阿奇霉素相关的ADE报告,利用报告比值法(ROR)和贝叶斯置信区间神经传播网络法(BCPNN)进行信号检测和分析处理.结果 总共挖掘到ADE信号 5498 个,总报告数量为 112485 份,最终提取阿奇霉素相关不良事件报告 31041 份,涉及阳性信号 898 个、系统器官分类 27 个,分类主要集中在呼吸系统疾病、感染及侵染类疾病、胃肠系统疾病等方面.此外,还发现了一些阿奇霉素可能导致的不良反应如哮喘、哮鸣,以及潜在不良反应如不全流产等.结论 应用阿奇霉素时,除了关注药品说明书中记载的阿奇霉素不良反应外,还应关注一些未被及时记录或更新的不良反应,以防说明书更新滞后所造成的用药安全风险,合理提供用药建议,保障患者的用药安全.
Signal Mining and Analysis of Adverse Events of Azithromycin Based FAERS Database
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reactions that have not been timely recorded or updated,in order to prevent the medication safety risks caused by outdated instructions,provide reasonable medication advice,and ensure the medication safety of patients.

AzithromycinAdverse drug eventsFDA adverse event reporting systemData mining and analysis data mining

彭青兰、罗佳露、余佳仪、汪凯鑫、吴芳、许传志

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三峡大学健康医学院,湖北 宜昌 443000

三峡大学皮肤性病研究所,湖北 宜昌 443000

昆明医科大学公共卫生学院,云南 昆明 650500

云南省教育厅公共卫生与疾病防控重点实验室,云南 昆明 650500

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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

2025

昆明医科大学学报
昆明医学院

昆明医科大学学报

影响因子:0.829
ISSN:1003-4706
年,卷(期):2025.46(1)