中国药物评价2025，Vol.42Issue(2)：153-160,8.
阿奇霉素在未成年人群中的不良事件信号挖掘
Adverse Events Signal Mining of Azithromycin in Pediatric Population Based on the ADR Database of Henan Province and FAERS Database
摘要
Abstract
Objective:Adverse events(AEs)signal mining of azithromycin in the pediatric population through the Henan Province Ad-verse Drug Reaction(ADR)Database and the FDA Adverse Event Reporting System(FAERS)database.Methods:Adverse reaction re-ports from January 1,2010 to December 31,2023 were extracted from the database.The reporting odds ratio(ROR)and proportional re-porting ratio(PRR)were used to mine the signals of azithromycin associated AEs.The signals were compared with the drug instruction and screened and analyzed with the Designated Medical Event(DME)list developed by the European Union.In addition,the induction time of azithromycin associated AEs was analyzed.Results:The database of Henan Province received 11 357 ADR reports of azithromy-cin,with a male-to-female ratio of 1.26∶1,and the highest number of reports in preschool children,involving 16 705 AEs and 23 SOCs,and detecting 26 positive PT signals.While the FAERS database received 1 741 ADR reports,with a male-to-female ratio of 1.11∶1,and the highest number of reports in school children,involving 5 318 AEs and 27 SOCs,and detecting 198 positive PT signals.Combining the results of the two databases,there were AEs not mentioned in the instructions such as crying,hallucination and ventricular fibrillation.Attention was paid to such as Stevens-Johnson syndrome,drug-induced liver injury and toxic epidermal necrolysis,which were rare or se-rious AEs consistent with the DME list.The majority of azithromycin associated AEs were induced within 2 d of drug administration espe-cially within 24 h.Conclusion:The AEs caused by azithromycin in children should not be ignored.Drug manufacturers and drug regulato-ry authorities should pay continuous attention to the safety of drug for clinical use in children,especially for new,serious,and rare AEs,and minimize and avoid the hazards of AEs by improving the instructions of the drugs.关键词
阿奇霉素/FAERS/儿童用药/比例失衡法/不良事件Key words
Azithromycin/FAERS/Pediatric medicine/Proportional imbalance method/Adverse events分类
医药卫生引用本文复制引用
李雨蔓,王静静,杨雪,陈晓博,彭亚丽,夏旭东..阿奇霉素在未成年人群中的不良事件信号挖掘[J].中国药物评价,2025,42(2):153-160,8.基金项目
河南省市场监督管理局科技计划(2023sj96) （2023sj96）
国家药监局药品监管科学体系建设重点项目(项目名称:真实世界数据支持儿童用药药物警戒工作开展的方法研究,项目编号:RS2024G001):国家药监局药物警戒研究和评价重点实验室项目(项目名称:真实世界数据用于儿童用药上市后安全性评价技术指导原则研究与制定,项目编号:CDRC20231001) （项目名称:真实世界数据支持儿童用药药物警戒工作开展的方法研究,项目编号:RS2024G001）
