中国医院用药评价与分析2025，Vol.25Issue(2)：244-246,252,4.DOI:10.14009/j.issn.1672-2124.2025.02.026
基于美国FAERS数据库的儿童应用米诺环素发生药品不良事件的信号挖掘与分析
Signal Mining and Analysis of Adverse Events Induced by Minocycline in Children Based on the U.S.Food and Drug Administration Adverse Drug Event Reporting System Database
关笑婵 1耿东丽 1钱奇芳 2段萌 3刘楠楠4
作者信息
- 1. 北京燕化医院药剂科,北京 102500
- 2. 中国人民解放军战略支援部队特色医学中心药学部,北京 100101
- 3. 北京市东城区第一人民医院药剂科,北京 100075
- 4. 中日友好医院药学部,北京 100029
- 折叠
摘要
Abstract
OBJECTIVE:To mine and analyze the adverse drug events induced by minocycline in children based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,so as to provide references for safe clinical medication.METHODS:Through the OpenVigil 2.1 platform,the data of adverse drug event reports with minocycline in patients<18 years from Jan.2004 to Sept.2023 in the U.S.FAERS database were retrieved,the related data were analyzed based on the report odds ratio method.RESULTS:A total of 888 adverse drug event reports with minocycline in children were retrieved,and 181 positive risk signals were found,involving 24 systemic organ classifications,mainly including various types of nervous system diseases,systemic diseases and various reactions at administration sites,hepatobiliary system diseases.The top 5 positive signals were acute thyroiditis(ROR=6 095.230),necrotizing vasculitis(ROR=1 745.871),eosinophilic myocarditis(ROR=604.196),fibromuscular dysplasia(ROR=429.429)and thyroiditis(ROR=418.641).Among them,as an adverse drug reaction not mentioned in the drug instructions,thyroiditis not only had higher positive signal,but ranked in the top 10 in terms of the number of reported cases.CONCLUSIONS:When minocycline is used in children,except for the known adverse drug events,increased attention needs to be paid to thyroiditis as well as acute thyroiditis,related indicators need to be monitored during medication,and the drug needs to be selected carefully.关键词
肺炎支原体/青春期痤疮/米诺环素/药品不良事件/美国食品药品监督管理局不良事件报告系统数据库Key words
Mycoplasma pneumoniae/Adolescent acne/Minocycline/Adverse drug event/U.S.Food and Drug Administration Adverse Event Reporting System Database分类
医药卫生引用本文复制引用
关笑婵,耿东丽,钱奇芳,段萌,刘楠楠..基于美国FAERS数据库的儿童应用米诺环素发生药品不良事件的信号挖掘与分析[J].中国医院用药评价与分析,2025,25(2):244-246,252,4.
