丙戊酸钠与左乙拉西坦比较治疗儿童癫痫有效性和安全性的系统评价与Meta分析

Efficacy and safety of sodium valproate compared with levetiracetam in children with epilepsy:a systematic review and Meta-analysis

目的比较丙戊酸钠与左乙拉西坦治疗儿童癫痫的有效性与安全性,重点关注该2种药物对患儿认知功能的影响。方法计算机检索The Cochrane Library、PubMed、Embase、中国知网、万方数据和中国生物医学文献数据库,检索时间均从建库至2021年11月30日。由2名研究者根据纳入排除标准独立进行文献筛选、数据提取和质量评价,并交叉核对,采用RevMan5.3软件进行Meta分析。结果共纳入7篇研究,其中3篇为随机对照实验(RCT),4篇为队列研究。共涉及629例患儿。Meta分析结果显示:有效性方面,使用左乙拉西坦单药治疗与丙戊酸钠组相比,无癫痫发作人数更多[OR=2.33,95%CI(1.47,3.70)]、≥50%反应率更高[OR=2.40,95%CI(1.51,3.81)];认知功能方面,左乙拉西坦组与丙戊酸钠组相比,韦氏儿童智力量表中言语智商(VIQ)[MD=1.60,95%CI(0.6,2.60)]、操作智商(PIQ)[MD=3.73,95%CI(2.86,4.59)]和全量表智商(FIQ)[MD=1.71,95%CI(0.83,2.59)]、蒙特利尔认知评估量表评分、神经心理学测试均更高;安全性方面,儿童使用左乙拉西坦与丙戊酸钠,不良反应发生率组间差异无统计学意义[OR=0.23,95%CI(0.05,1.09),P=0.06]。结论与丙戊酸钠相比,左乙拉西坦单药治疗儿童癫痫的有效性较好、对认知功能的影响较小,安全性相当。受纳入研究质量和样本数量的限制,该结论尚需更多高质量研究予以验证。

AIM To compare the efficacy and safety of sodium valproate and levetiracetam in the treatment of childhood epilepsy,focusing on the effects of the two drugs on cognitive function in children.METHODS The Cochrane Library,PubMed,Embase,CNKI,Wanfang Data,and Chinese Biomedical Literature Database were searched by computer from databases establishment to November 30,2021.Two investigators independently performed literature screening,data extraction and quality evaluation according to the inclusion and exclusion criteria,and cross-checked.Meta-analysis was performed using RevMan5.3 software.RESULTS A total of 7 studies were included,of which 3 were randomized controlled trials(RCTs)and 4 were cohort studies.A total of 629 children were involved.The result of Meta-analysis showed:in terms of effectiveness,compared with the sodium valproate group,levetiracetam mondrug treatment was associated with more seizure-free patients[OR=2.33,95%CI(1.47,3.70)]and higher≥50%response rate[OR=2.40,95%CI(1.51,3.81)];in terms of cognitive function,compared with sodium valproate group,the verbal intelligence quotient(VIQ)[MD=1.60,95%CI(0.6,2.60)],performance intelligence quotient(PIQ)[MD=3.73,95%CI(2.86,4.59)]and full scale intelligence quotient(FIQ)[MD=1.71,95%CI(0.83,2.59)],montreal cognitive assessment score,and neuropsychological tests were higher in the levetiracetam group than in sodium valproate group.In terms of safety,there was no significant difference in the incidence of adverse reactions between levetiracetam group and sodium valproate group in children[OR=0.23,95%CI(0.05,1.09),P=0.06].CONCLUSION Compared with sodium valproate,levetiracetam monotherapy is more effective.It has less impact on cognitive function,and has equivalent safety in the treatment of childhood epilepsy.Limited by the quality of included studies and the number of samples,this conclusion still needs to be verified by more high-quality studies.