摘要
目的挖掘吡仑帕奈精神不良反应风险信号,为该药的临床安全应用提供参考。方法检索美国FDA不良事件报告数据库(FAERS),收集2012年第3季度至2021年第3季度以吡仑帕奈为首要怀疑药物的精神不良事件(AE)报告。采用国际医学用语词典的首选术语(PT)对AE进行标准化。从AE报告中提取患者一般情况和精神AE结局等数据进行描述性统计分析。采用报告比值比(ROR)法进行吡仑帕奈精神不良反应风险信号挖掘,报告数≥3且ROR值的95%置信区间下限>1的PT定义为阳性信号。结果共收集到以吡仑帕奈为首要怀疑药物的精神AE报告922例,所涉922例患者中男性439例(47.6%),女性441例(47.8%),性别不详42例(4.6%);有年龄记载者676例,为(38±19)岁;有AE结局记载者807例,因AE导致住院/住院时间延长、需要紧急治疗、危及生命和死亡者分别为409例(44.4%)、316例(34.3%)、60例(6.5%)和22例(2.4%)。922例AE报告涉及1580个PT,ROR法检测出阳性信号的PT为46个,其中AE报告数排在前5位的PT为攻击(286例)、易激惹(128例)、自杀意念(110例)、实施自杀行为(100例)和愤怒(77例),信号强度(ROR值)排在前5位的PT为抽搐后精神病(383.13)、精神分裂症样障碍(355.27)、杀人意念(203.56)、分离性障碍(119.64)和妄想知觉(108.34),其中分离性障碍、抽搐后精神病为药品说明书中未记载的AE。46个阳性信号PT中共14个(30.4%)在药品说明书中未记载,其他12个PT按信号强度(ROR值)由高至低依次为不当性行为(81.43)、多疑(65.20)、去抑制状态(32.72)、行为冲动(31.18)、人格改变(22.56)、行为异常(16.31)、社交回避行为(12.95)、躁动(6.15)、双相情感障碍(5.23)、情感易变(5.09)、梦魇(2.86)和恐惧(2.79)。结论精神不良反应是吡仑帕奈较常见且较严重的不良反应,应引起临床重视。
Objective To explore the adverse reaction risk signals of perampanel-related psychia-tric disorders,and provide reference for the clinical safe application of perampanel.Methods The US FDA Adverse Event Reporting System database was searched,and the adverse event(AE)reports on psy-chiatric disorders from the third quarter of 2012 to the third quarter of 2021,which judged perampanel as the primary suspect drug were collected.The expression of AE was standardized using the preferred term(PT)in the Medical Dictionary for Regulatory Activities.Data such as patient general condition and psychiatric AE outcomes was extracted from AE reports and was analyzed descriptively.Risk signal mining for psychiatric adverse reactions to perampanel was performed using the reporting odds ratio(ROR)method.The positive signal PT was set as that the number of AE reports was 3 and more and the lower limit of the 95%confidence interval(CI)of the ROR was greater than 1.Results A total of 922 reports on psychiatric AE with perampanel as the primary suspect drug were collected.Of the 922 patients involved,439 were male,441 were female,and 42 were unknown in gender.Age were recorded in 676 patients,and the age was(38±19)years.AE outcomes were recorded in 807 patients,of which hospitalization/prolonged hospitalization,urgent treatment needs,life threatening,and death due to AE occurred respectively in 409(44.4%),316(34.3%),60(6.5%)and 22 patients(2.4%).The 922 AEs involved 1-580 PTs,and 46 PTs were detected with positive signals by ROR method.The top 5 PTs mostly reported were aggression(286 AEs),irritability(128 AEs),suicidal ideation(110 AEs),suicide attempt(100 AEs),and anger(77 AEs).The top 5 PTs with strongest signal intensity(ROR value)were postictal psychosis(383.13),schizophreniform disorder(355.27),homicidal ideation(203.56),dissociative disorder(119.64)and delusional perception(108.34),among which dissociative disorder and postictal psychosis were AEs not recorded in the drug labels.In the 46 PTs with positive signal,14(30.4%)were
作者
顾中盛
季春梅
Gu Zhongsheng;Ji Chunmei(Department of Pharmacy,Jiangsu Province Hospital,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China)
出处
《药物不良反应杂志》
CSCD
2022年第12期647-651,共5页
Adverse Drug Reactions Journal
