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

作　　者：关笑婵 耿东丽 钱奇芳 段萌 刘楠楠[4] GUAN Xiaochan;GENG Dongli;QIAN Qifang;DUAN Meng;LIU Nannan(Dept.of Pharmacy,Beijing Yanhua Hospital,Beijing 102500,China;Dept.of Pharmacy,Special Medical Center,Strategic Support Force of PLA,Beijing 100101,China;Dept.of Pharmacy,the First People’s Hospital of Beijing Dongcheng District,Beijing 100075,China;Dept.of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China)

机构地区：[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

出　　处：《中国医院用药评价与分析》2025年第2期244-246,252,共4页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库,对儿童应用米诺环素发生药品不良事件报告进行数据挖掘和分析,为临床安全用药提供参考。方法:通过OpenVigil 2.1平台,检索2004年1月至2023年9月美国FAERS数据库中<18岁患者使用米诺环素发生药品不良事件报告数据,基于报告比值比法,对相关数据进行分析。结果:共检索到儿童应用米诺环素发生药品不良事件报告888例,发现181个阳性风险信号,涉及24个系统器官分类,主要包括各类神经系统疾病、全身性疾病及给药部位各种反应、肝胆系统疾病等,前5位阳性信号为急性甲状腺炎(ROR=6095.230)、坏死性血管炎(ROR=1745.871)、嗜酸性粒细胞增多性心肌炎(ROR=604.196)、肌纤维发育不良(ROR=429.429)和甲状腺炎(ROR=418.641)。其中,甲状腺炎为药品说明书中未提及的不良反应,不仅阳性信号较高,其报告例次数排序也居前10位。结论:米诺环素用于儿童时,除已知的药品不良事件外,需要加强关注甲状腺炎以及急性甲状腺炎,在用药期间需监测相关指标,谨慎选择药物。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=6095.230),necrotizing vasculitis(ROR=1745.871),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 

分 类 号：R978.1[医药卫生—药品] R969.3[医药卫生—药学]