摘要
目的挖掘儿童使用哌甲酯的不良事件(AE)风险信号, 为临床安全使用该药提供参考。方法检索美国FDA不良事件报告系统数据库, 收集2004年第1季度至2023年第1季度以哌甲酯为首要怀疑药物的儿童AE报告, 采用《国际医学用语词典》26.0版首选术语(PT)和系统器官分类(SOC)对AE进行标准化和分类。采用报告比值比(ROR)法和贝叶斯置信传播神经网络(BCPNN)法挖掘哌甲酯AE风险信号, 报告数≥3且ROR的95%置信区间(CI)下限>1, 信息成分-2×标准差(IC-2SD)>0的AE定义为风险信号, 对其PT进行描述性分析。结果共收集儿童哌甲酯相关AE报告13 777份。采用ROR法和BCPNN法获得200个风险信号, 涉及18个SOC。报告数居前10位的PT依次为食欲减退、攻击、头痛、失眠、激越、精神运动功能亢进、焦虑、易激惹、抽动和自杀想法, 其中自杀想法在说明书中未记载;涉及SOC为精神病类、代谢及营养类疾病和各类神经系统疾病。信号强度居前10位的PT依次为冠状动脉夹层、亨廷顿病、动物恐怖、抠甲癖、精神性烦渴、强迫性咬唇癖、爱丽丝梦游仙境综合征、郁闷、咬甲癖和强迫性皮肤搔抓症, 除郁闷外均为说明书未记载的不良反应;涉及的SOC为心脏器官疾病、各种先天性家族性遗传性疾病、精神病类。结论儿童中哌甲酯相关AE主要为食欲减退、攻击、头痛、失眠等说明书已记载的不良反应;哌甲酯还可能导致自杀想法、冠状动脉夹层、亨廷顿病、抠甲癖等说明书中未记载的AE, 临床医师和药师应予以警惕。
Objective To mine risk signals of adverse events(AE)related to methylphenidate in children,and provide insights for the safe clinical use of the drug.Methods AE reports of children with methylphenidate as primary suspect drug were collected from the US FDA Adverse Event Reporting System(FAERS)database during the 1st quarter of 2004 to the 1st quarter of 2023.The AEs were standardized and classified using the preferred term(PT)and system organ class(SOC)of the Medical Dictionary for Regulatory Activities 26.0,and the reporting odds ratio(ROR)method and Bayesian confidence propagation nerve(BCPNN)method were used respectively to mine the AE risk signals of the drug.An AE with reports≥3,the lower limit of the 95%CI of ROR>1,and information component(IC)-2SD>0 was defined as a risk signal.Descriptive analysis on the risk signals was performed.Results A total of 13777 reports were collected.Two hundred risk signals were obtained using ROR and BCPNN method,involving 18 SOCs.Top 10 PTs in the number of reports were decreased appetite,aggression,headache,insomnia,agitation,psychomotor hyperactivity,anxiety,irritability,tics,and suicidal ideation,of which suicidal ideation was not recorded in the label;the SOCs involved were psychiatric disorders,metabolism and nutrition disorders,nervous system disorders.Top 10 PTs by signal strength were coronary artery dissection,Huntington′s disease,zoophobia,nail picking,polydipsia,lip-biting disorder,Alice in Wonderland syndrome,depression,onychophagia,and dermatillomania,all adverse reactions except depression were not recorded in the label;the SOCs involved were cardiac disorders,various congenital familial genetic disorders,and psychiatric disorders.Conclusions The main AEs related to methylphenidate in children are decreased appetite,aggression,headache,insomnia,and other adverse reactions recorded in the label.However,methylphenidate may also lead to adverse reactions such as suicidal ideation,coronary artery dissection,Huntington′s disease,nail picking,and other adverse reactions not recorded in the label.Clinicians and pharmacists should be vigilant during the use of methylphenidate.
作者
李媛
张雯雯
张雨晨
Li Yuan;Zhang Wenwen;Zhang Yuchen(Department of Pharmacy,Xi′an Children′s Hospital,Xian 710003,China;Department of Pharmacy,the Affiliated Hospital of Northwest University,Xi′an No.3 Hospital,Xi′an 710018,China)
出处
《药物不良反应杂志》
CSCD
2024年第9期530-534,共5页
Adverse Drug Reactions Journal
关键词
注意缺陷多动障碍
哌甲酯
儿童
数据挖掘
药物不良事件报告系统
Attention deficit disorder with hyperactivity
Methylphenidate
Children
Data mining
Adverse events reporting system database
