山东医药2024，Vol.64Issue(30)：14-18,5.DOI:10.3969/j.issn.1002-266X.2024.30.004
基于美国FDA不良事件报告系统相关数据分析服用米诺环素的8～18岁患者药品不良反应及其高危因素
ADEs of minocycline and high-risk factors in children aged 8-18 years based on data from FAERS
摘要
Abstract
Objective To explore the adverse drug events(ADEs)of minocycline and high-risk factors in children aged 8 to 18 years based on the US Food and Drug Administration(FDA)adverse event reporting system(FAERS),and to provide reference for the safe use of minocycline in clinic.Methods Reports of minocycline as the"primary suspect-ed(PS)"ADE reports were retrieved from the FAERS from January 2004 to September 2023.High-risk factors for the oc-currence of minocycline ADEs were screened by utilizing both the reporting odds ratio(ROR)and the Medicines and Healthcare products Regulatory Agency(MHRA).Results that satisfied the a≥3,95%CI>1,PRR≥2,and χ2≥4 were identified as risk signals.ADEs were classified and analyzed by adopting the system organ class(SOC)and preferred term(PT)from the Medical Dictionary for Regulatory Activities(MedDRA).Results A total of 668 suspected cases of mino-cycline ADEs in children aged 8 to 18 were obtained,and 181 high-risk factors for minocycline ADEs were identified,in-volving 22 SOC,including neurological disorders,skin and subcutaneous tissue diseases,and general disorders and ad-ministration site conditions.The top 5 most frequent ADEs included drug reaction with eosinophilia and systemic symp-toms,pyrexia,headache,idiopathic intracranial hypertension,and arthralgia.The top 5 ADEs exhibiting the highest risk factors were thyroiditis acute,meningitis eosinophilic,vasculitis necrotizing,mononeuropathy multiplex,and eosinophilic myocarditis.Conclusions The high-risk factors for minocycline-induced ADEs in children aged 8-18 years include vari-ous neurological diseases,diseases of the skin and subcutaneous tissues,systemic diseases,and various reactions at the administration site,etc.Minocycline ADEs in clinical applications include acute thyroiditis,eosinophilic encephalitis,thyroiditis,and intestinal obstruction,etc.关键词
药品不良反应/四环素/米诺环素/美国食品药品监督管理局不良事件报告系统Key words
adverse drug event/tetracyclines/minocycline/US Food and Drug Administration(FDA)adverse event reporting system分类
医药卫生引用本文复制引用
张旭升,王晓骏,王丽,任秀丽,沈承武,卢翠翠..基于美国FDA不良事件报告系统相关数据分析服用米诺环素的8～18岁患者药品不良反应及其高危因素[J].山东医药,2024,64(30):14-18,5.基金项目
山东省药品化妆品监测哨点课题(2022SDADRKY01 （）
2023SDADRKY21 （）
2023SDADRKY39). （）
