Objective 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). Data source 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. Study selection 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. Data extraction 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. Data synthesis 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. Conclusion 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.

中文翻译：

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左乙拉西坦与苯妥英作为小儿惊厥性癫痫持续状态二线抗癫痫药物的疗效和安全性：随机对照试验的系统评价和荟萃分析

目的比较左乙拉西坦（LEV）与苯妥英（PHT）作为二线抗癫痫药物（ASM）治疗小儿惊厥性癫痫持续状态（SE）的疗效和安全性。数据来源 PubMed、Embase、谷歌学者/谷歌、Scopus、护理和相关健康文献累积索引 (CINAHL)、Cochrane 系统评价数据库和 Cochrane 对照试验中央登记册。研究选择 评估 LEV 和 PHT 作为 2000 年 1 月 1 日至 2020 年 11 月 30 日期间<18 岁儿童惊厥性 SE 的二线药物的随机对照试验 (RCT)。研究药物输注完成后 5-60 分钟（主要结果）；和癫痫发作在 5 分钟内停止，达到癫痫发作停止的时间，1 至 24 小时内癫痫复发、插管和心血管不稳定（次要结果）。使用 RevMan 5.4 版分析数据，并使用 Cochrane 偏倚风险工具进行质量分析。研究方案已在 PROSPERO 注册。数据综合 纳入 12 项 RCT，共 2293 名儿童。两种药物在 5-60 分钟内停止癫痫发作相似 [LEV 为 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 小时内的癫痫复发率更高（16.6% 对 9.7%，RR = 0.63，95% CI 0.44-0.90，p = 0.01）。PHT 组中较高比例的儿童需要插管和机械通气（21.4% 对 14.2%，RR = 0.54，95% CI 0.30-0.98，p = 0.04）。癫痫发作在 5 分钟内停止，达到癫痫发作停止的时间，两种药物的心血管不稳定性相似。三项随机对照试验处于低偏倚风险，九项处于高偏倚风险。结论 LEV作为二线ASM治疗小儿惊厥性SE的疗效与PHT相似。与 LEV 相比，PHT 组 1 至 24 小时的癫痫发作复发率以及插管和机械通气的需求显着更高。