评价左乙拉西坦(LEV)与苯妥英钠(PHT)二线抗癫痫药物(ASM)治疗小儿惊厥性癫痫持续状态(SE)的疗效和安全性。
PubMed,Embase,谷歌学者/谷歌,Scopus,护理和相关健康文献累积指数(CINAHL),Cochrane系统评价数据库和Cochrane对照试验中央登记册。
2000年1月1日至2020年11月30日发表的评估LEV和PHT作为18岁以下儿童惊厥性SE二线药物的随机对照试验(RCT)。
收集了关于在完成研究药物输注后5-60分钟内实现癫痫发作停止的儿童比例的数据(主要结果);以及在5分钟内癫痫发作停止的儿童比例,是时候停止癫痫发作了,癫痫发作复发1至24小时,插管和心血管不稳定(次要结局)。使用RevMan5.4版分析数据,并使用Cochrane偏差风险工具进行质量分析。研究方案在PROSPERO注册。
纳入了12个RCT,其中2293名儿童。两种药物在5-60分钟内停止癫痫发作相似[LEV与82%PHT为77.5%,风险比(RR)=1.04,95%置信区间(95%CI)0.97-1.11,p=0.30]。与LEV相比,PHT在1-24小时内的癫痫发作复发更高(16.6%vs.9.7%,RR=0.63,95%CI0.44-0.90,p=0.01)。PHT组需要插管和机械通气的儿童比例较高(21.4%vs.14.2%,RR=0.54,95%CI0.30-0.98,p=0.04)。在5分钟内停止癫痫发作,是时候停止癫痫发作了,两种药物的心血管不稳定性相似。三个随机对照试验的偏倚风险较低,九个偏倚风险较高。
LEV作为儿科惊厥性SE的二线ASM的疗效与PHT相似。与LEV相比,PHT在1到24小时之间的癫痫发作复发以及插管和机械通气的要求明显更高。
To evaluate the efficacy and safety of levetiracetam (LEV) in comparison to phenytoin (PHT) as second line antiseizure medication (ASM) for Pediatric convulsive status epilepticus (SE).
PubMed, Embase, Google scholar/Google, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials.
Randomized controlled trials (RCTs) assessing LEV and PHT as second line agent for convulsive SE in children <18 years published between 1 January 2000 and 30 November 2020.
The data were pooled regarding the proportion of children achieving seizure cessation within 5-60 min of completion of study drug infusion (primary outcome); and seizure cessation within 5 min, time to achieve seizure cessation, seizure recurrence between 1 to 24 h, intubation and cardiovascular instability (secondary outcomes). Data were analyzed using RevMan version 5.4 and quality analysis was done using Cochrane risk-of-bias tool. The study protocol was registered with PROSPERO.
Twelve RCTs with 2293 children were included. Seizure cessation within 5-60 min was similar with both the drugs [82% in LEV vs. 77.5% in PHT, risk ratio (RR) = 1.04, 95% confidence interval (95% CI) 0.97-1.11, p = 0.30]. Seizure recurrences within 1-24 h was higher with PHT in comparison to LEV (16.6% vs. 9.7%, RR = 0.63, 95% CI 0.44-0.90, p = 0.01). Higher proportion of children in PHT group required intubation and mechanical ventilation (21.4% vs. 14.2%, RR = 0.54, 95% CI 0.30-0.98, p = 0.04). Seizure cessation within 5 min, time to achieve seizure cessation, and cardiovascular instability were similar with both the drugs. Three RCTs were at low risk of bias and nine were at high risk of bias.
The efficacy of LEV is similar to PHT as second line ASM for Pediatric convulsive SE. Seizure recurrences between 1 to24 h and requirement of intubation and mechanical ventilation were significantly higher with PHT in comparison to LEV.