摘要
目的基于美国FDA不良事件报告系统(FAERS)数据库数据分析8~18岁儿童米诺环素药品不良反应及其发生的高危因素,为米诺环素的临床安全用药提供参考。方法在FAERS中检索2004年1月—2023年9月中疑似米诺环素导致的药品不良事件(ADE),采用报告比值比法(ROR)及综合标准法(MHRA)筛选a≥3、95%CI>1、PRR值≥2、χ^(2)≥4的米诺环素ADE发生的高危因素,采用国际医学用语词典(MedDRA)对米诺环素ADE发生的高危因素进行首选器官分类(SOC)和首选术语归类(PT)。结果共得到8~18岁儿童的疑似米诺环素ADE3668份,最终得到米诺环素ADE发生的高危因素181个,涉及各类神经系统疾病、皮肤及皮下组织类疾病和全身性疾病及给药部位各种反应等22个SOC。发生频次前5位的米诺环素ADE分别为药物反应伴嗜酸粒细胞增多和全身性症状、发热、头痛、特发性颅内压增高和关节痛;米诺环素ADE发生的高危因素分别为急性甲状腺炎、嗜酸细胞性脑炎、坏死性血管炎、多发性单神经病和嗜酸粒细胞增多性心肌炎。结论8~18岁儿童应用米诺环素时ADE发生的高危因素包括各类神经系统疾病、皮肤及皮下组织类疾病和全身性疾病及给药部位各种反应等。临床应用中米诺环素ADE包括急性甲状腺炎、嗜酸细胞性脑炎、甲状腺炎和肠梗塞等。
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 suspected(PS)”ADE reports were retrieved from the FAERS from January 2004 to September 2023.High-risk factors for the occurrence 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,andχ^(2)≥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 minocycline ADEs in children aged 8 to 18 were obtained,and 181 high-risk factors for minocycline ADEs were identified,involving 22 SOC,including neurological disorders,skin and subcutaneous tissue diseases,and general disorders and administration site conditions.The top 5 most frequent ADEs included drug reaction with eosinophilia and systemic symptoms,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 various 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.
作者
张旭升
王晓骏
王丽
任秀丽
沈承武
卢翠翠
ZHANG Xusheng;WANG Xiaojun;WANG Li;REN Xiuli;SHEN Chengwu;LU Cuicui(Department of Pharmacology,Shandong Provincial Hospital Affiliated to Shandong First Medical University,Jinan 250021,China;不详)
出处
《山东医药》
CAS
2024年第30期14-18,共5页
Shandong Medical Journal
基金
山东省药品化妆品监测哨点课题(2022SDADRKY01,2023SDADRKY21,2023SDADRKY39)。
