左乙拉西坦和苯妥英钠治疗儿童惊厥性癫痫持续状态疗效与安全性meta分析

The efficacy and safety of levetiracetam and phenytoin in the treatment of children with convulsive status epilepticus:a meta-analysis

目的评估左乙拉西坦(LEV)和苯妥英钠(PHT)治疗儿童惊厥性癫痫持续状态(CSE)的疗效与安全性。方法检索PubMed、Web of Science、Cochrane Library、Embase、中国知网(CNKI)、万方数据库、中国生物医学文献数据库(CBM)和维普中文科技期刊数据库(VIP),检索时限均为各数据建库起至2020年7月17日,筛选静脉滴注PHT(对照组)以及静脉滴注LEV(干预组)治疗儿童CSE患者的前瞻性随机对照试验(RCT)。提取符合纳入标准的研究资料并评价质量,使用Rev Man 5.3软件行meta分析。结果纳入7项RCT,共计1647例CSE患儿。meta分析结果显示,LEV组60分钟内临床癫痫发作完全控制率(75.04%)略高于PHT组(71.43%),但差异无统计学意义(RR=1.06,95%CI:1.00~1.13,P=0.06);LEV组24小时内临床复发率(RR=0.93,95%CI:0.50~1.74,P=0.83)、死亡率(RR=0.89,95%CI:0.18~4.48,P=0.89)、入住ICU率(RR=1.11,95%CI:0.96~1.28,P=0.17)与PHT组相比,差异无统计学意义;LEV组的不良事件总发生率低于PHT组,差异有统计学意义(RR=0.74,95%CI:0.60~0.92,P=0.006)。结论对于苯二氮卓类药物治疗失败后的儿童CSE患者,LEV和二线首选药物PHT的疗效相当,但不良事件总发生率低,可考虑作为PHT的合适替代品。

Objective To comprehensively evaluate the efficacy and safety of levetiracetam(LEV)versus phenytoin(PHT)in the treatment of convulsive status epilepticus(CSE)in children.Methods The PubMed,Web of Science,Cochrane Library,Embase,CNKI,Wanfang Database,China Biomedical Literature Database(CBM)and VIP Chinese science and technology periodical database(VIP)were retrieved.The retrieval period is from the database construction to July 17,2020.Prospective randomized controlled trials(RCTs)of intravenous PHT(control group)and intravenous LEV(intervention group)for the treatment of children with CSE were screened.The data that met the inclusion criteria were extracted and their quality was evaluated,and meta-analysis was performed using Rev Man 5.3 software.Results A total of 7 RCTs were included,including 1647 children with CSE.The meta-analysis results showed that the complete control rate of clinical seizures within 60 minutes in the LEV group was slightly higher than that in the PHT group,but the difference was not statistically significant(RR=1.06,95%CI:1.00-1.13,P=0.06).There was no statistical difference in clinical recurrence rate within 24 hours(RR=0.93,95%CI:0.50-1.74,P=0.83),mortality rate(RR=0.89,95%CI:0.18-4.48,P=0.89),ICU admission rate(RR=1.11,95%CI:0.96-1.28,P=0.17)between the LEV group and the PHT group.The total incidence of adverse events in the LEV group was lower than that in the PHT group,and the difference was statistically significant(RR=0.74,95%CI:0.60-0.92,P=0.006).Conclusions LEV is comparable to the second-line preferred drug PHT in children with CSE after benzodiazepine treatment failure;furthermore,LEV has low overall incidence of adverse events and may be considered as a suitable alternative to PHT.