摘要
目的分析布瓦西坦致儿童不良反应(ADR)的一般规律及特点,为临床安全用药提供参考。方法以“布瓦西坦”“布立西坦”“不良反应”和“副作用”等为中文检索词,以“Brivaracetam”“adverse reaction”“adverse effects”“ADR”和“side effect”等为英文检索词,对中国学术期刊全文数据库(CNKI)、万方数据库(Wanfang Data)、维普生物医学数据库(VIP)、PubMed、Web of Sciene和Embase等数据库进行文献检索,检索时限均为数据库建库起至2024年1月31日。对纳入研究患者性别、年龄、用药情况、联合用药、ADR临床表现等进行统计分析。结果共纳入文献13篇,纳入病例849例,其中男性458例(53.9%)、女性391例(46.1%),ADR共累及6个系统/器官,以神经系统(39.22%)和精神疾病(31.86%)为主,包括嗜睡、癫痫发作恶化、抽搐、易怒、攻击性、精神运动机能亢进、行为问题等。大多数ADR是可逆且预后良好的,但仍有部分患者在进行干预治疗后产生了不良结局,甚至死亡。结论布瓦西坦可致儿童严重ADR的发生,临床应关注该药的合理使用,加强用药监护和随访,以确保患者临床用药安全。
Objective To analyze the general rules and characteristics of adverse drug reactions caused by brivaracetam in children,and to provide reference for clinical safety of drug use.Methods Clinical trial studies and case reports of adverse drug reactions caused by brivaracetam in children were searched from PubMed,CNKI,WanFang Data and VIP.The time limit for the search was from the establishment of the databases to January 31,2024.The gender,age,usage and dosage of brivaracetam,combined drug use and ADR clinical manifestations of patients were statistically analyzed.Results A total of 13 literatures were included,with a total of 849 patients,including 458 males(53.9%)and 391 females(46.1%).ADR involved 6 systems/organs,which were mainly nervous system(39.22%)and mental diseases(31.86%),such as somnolence,seizure worsening,convulsion,irritability,aggression,psychomotor hyperactivity,behavioral problems.The most of ADR are reversible and have a good prognosis,but some patients still have adverse outcomes or even death after active treatment.Conclusions Brivaracetam can cause serious ADR in children.Clinical attention should be paid to the rational use of brivaracetam,and the monitoring and follow-up should be strengthened to ensure the safety ofpatients.
作者
马胜男
范宏光
张建红
史海雯
李昌军
MA Shengnan;FAN Hongguang;ZHANG Jianhong;SHI Haiwen;LI Changjun(Department of Pharmacy,Tianjin Fourth Central Hospital,Tianjin 300140,China;Department of Neurology,Tianjin Fourth Central Hospital,Tianjin300140,China)
出处
《药物评价研究》
CAS
北大核心
2024年第5期1079-1085,共7页
Drug Evaluation Research
基金
天津市卫生健康委中医中西医结合科研课题(2023219)
天津市第四中心医院2021年度优秀青年人才重点培养项目(tjd‐szxyy20210023)。
关键词
布瓦西坦
儿童
癫痫
药品不良反应
神经系统
精神疾病
brivaracetam
children
epilepsy
adverse drug reactions
nervous system
mental diseases