摘要
目的 系统评价托吡酯对儿童认知功能的影响。方法 计算机检索PubMed、The Cochrane Library、EMBASE(Ovid)、中国生物医学文献数据库、中国知网、万方数据库和维普数据库,检索托吡酯治疗癫痢或偏头痛对儿童认知功能影响的中英文文献(建库至2014年9月15日)。2名研究员独立筛选文献、评价文献质量和提取资料。采用无对照二分类资料的Meta分析,定量分析认知不良事件的发生率,描述性分析不同认知功能测量工具测量的认知功能效应指标。结果 检索获得676篇相关文献,9篇文献(3篇RCT和6篇病例系列报告)进入系统评价,共纳入1240例患儿。2篇RCT文献为低度偏倚,1篇RCT文献为高度偏倚,6篇病例系列报告均为低度偏倚。①Meta分析结果显示:认知不良事件困惑焦虑、精神运动性障碍、注意力难以集中、感觉异常、情绪异常、疲倦、嗜睡的发生率有统计学意义,发生率及其95%C1分别为0.03(0.01~0.06)、0.08(0.02~0.26)、0.07(0.02~0.21)、0.07(0.04~0.14)、0.05(0.02~0.11)、0.05(0.05~0.10)和0.12(0.04~0.28);记忆力降低、语言障碍的发生率无统计学意义。②认知功能测量工具测量的认知功能效应指标的描述性分析显示,托吡酯对儿童认知功能的影响显著低于卡马西平;托吡酯用量达100mg·d^-1时,会轻微延长反应时问,但不对记忆力造成影响;起始用托吡酯单药治疗和其他抗癫痫药无效转为托吡酯单药治疗,对癫痫儿童认知功能的影响无统计学意义。0、0托吡酯对儿童认知不良事件有一定影响,但发生率较低;托吡酯可引起运动反应时间轻微延长,但对记忆力影响不大。
Objective A systematic review was conducted to assess the influence of topiramate on children's cognitive function to provide high quality evidence for clinical practice. M ethods The literatures were searched using Pub Med,Cochrane Library,EMBASE( Ovid),China Biology Medicine disc( CBM),China National Knowledge Infrastructure( CNKI),Wan Fang Data,VIP database from establishment until now. Two researchers independently screened the studies using predetermined inclusion and exclusion criteria and assessed the quality of these studies and extracted the data. Quantitative analysis of cognitive-related ADEs was performed using meta-analysis with non-comparative binary data,the outcome measured by different scales was represented.Results 676 studies were found and 9 studies were finally included in this systematic review,3 RCTs and 6 case series,including1 240 patients. Among 9 experimental studies,2 RCTs and 6 case series indicated low risk bias,1 RCT had high risk bias. The incidence and 95% confidence interval of cognitive-related ADEs: confusion 0. 03( 0. 01- 0. 06),psychomotor slowing 0. 08( 0. 02- 0. 26),difficulty with concentration/attention 0. 07( 0. 02- 0. 21),word-finding difficulties0. 07( 0. 04- 0. 14),depression or mood problems 0. 05( 0. 02- 0. 11),fatigue 0. 05( 0. 02- 0. 10),somnolence 0. 12( 0. 04- 0. 28),difficulty with memory and speech or language problems were without statistical significance. Cognitive function was worsen treated by TPM than VPA,topiramate 100 mg per day was associated with increases in psychomotor reaction times but memory was unchanged,there were no significant differences between TPM monotherapy and converting monotherapy. Conclusion The incidence of cognitiverelated ADEs was low in children received topiramate treatment. Topiramate was associated with modest increases in psychomotor reaction times. Learning and memory were unchanged in migraine children.
出处
《中国循证儿科杂志》
CSCD
北大核心
2015年第1期57-61,共5页
Chinese Journal of Evidence Based Pediatrics
基金
国家自然科学基金:81373381
关键词
系统评价
托吡酯
认知功能
不良事件
儿童
META分析
Systematic review
Topiramate
Cognitive function
Adverse drug events
Children
Meta analysis