Department of Pediatrics, Faculty of Medicine, Sohag University, Sohag, Egypt.
Department of Pediatrics, Faculty of Medicine, Sohag University, Sohag, Egypt. Correspondence to: Dr Elsayed Abdelkreem, Department of Pediatrics, Faculty of Medicine, Sohag University, Sohag 82524, Egypt.
Indian Pediatr. 2023 Aug 15;60(8):630-636. Epub 2023 Mar 20.
Benzodiazepines are the first-line anti-seizure medication (ASM) for generalized convulsive status epilepticus (GCSE), but they fail to end seizures in a third of cases. Combining benzodiazepines with another ASM that acts by a different pathway could be a potential strategy for rapid control of GCSE.
To evaluate the efficacy of adding levetiracetam to midazolam in the initial treatment of pediatric GCSE.
Double-blind randomized controlled trial.
Pediatric emergency room at Sohag University Hospital between June, 2021 and August, 2022.
Children aged between 1 month and 16 years with GCSE lasting more than 5 min.
Intravenous levetiracetam (60 mg/kg over 5 min) and midazolam (Lev-Mid group) or placebo and midazolam (Pla-Mid group) as first-line anticonvulsive therapy.
Primary: cessation of clinical seizures at 20-min study time point. Secondary: cessation of clinical seizures at 40-min study time point, need for a second midazolam dose, seizure control at 24-hr, need for intubation, and adverse effects.
Cessation of clinical seizures at 20-min occurred in 55 children (76%) in Lev-Mid group compared with 50 (69%) in the Pla-Mid group [RR (95% CI) 1.1 (0.9-1.34); P=0.35]. No significant difference was found between the two groups regarding the need for a second midazolam dose [44.4% vs 55.6%; RR (95% CI) 0.8 (0.58-1.11); P=0.18] as well as cessation of clinical seizures at 40-min [96% vs 92%; RR (95% CI)1.05 (0.96-1.14); P=0.49] and seizure control at 24-hr [85% vs 76%; RR (95% CI) 1.12 (0.94-1.3); P=0.21]. Intubation was required for three patients in the Lev-Mid group and six patients in the Pla-Mid group [RR (95%CI) 0.5 (0.13- 1.92); P=0.49]. No other adverse effects or mortality were observed during the 24-hour study timeframe.
Combined levetiracetam and midazolam for initial management of pediatric GCSE presents no significant advantage over midazolam alone in cessation of clinical seizures at 20-min.
苯二氮䓬类药物是全身性惊厥性癫痫持续状态（GCSE）的一线抗癫痫药物（ASM），但它们在三分之一的病例中无法终止癫痫发作。将苯二氮䓬类药物与另一种通过不同途径起作用的 ASM 联合使用可能是快速控制 GCSE 的潜在策略。
评估左乙拉西坦联合咪达唑仑在儿科 GCSE 初始治疗中的疗效。
双盲随机对照试验。
2021 年 6 月至 2022 年 8 月在索哈格大学医院的儿科急诊室。
年龄在 1 个月至 16 岁之间、GCSE 持续时间超过 5 分钟的儿童。
静脉注射左乙拉西坦（60mg/kg 持续 5 分钟）和咪达唑仑（Lev-Mid 组）或安慰剂和咪达唑仑（Pla-Mid 组）作为一线抗惊厥治疗。
主要结局：在 20 分钟的研究时间点停止临床癫痫发作。次要结局：在 40 分钟的研究时间点停止临床癫痫发作、需要第二次咪达唑仑剂量、24 小时内癫痫控制、需要插管和不良反应。
Lev-Mid 组 55 名儿童（76%）在 20 分钟时停止临床癫痫发作，而 Pla-Mid 组 50 名儿童（69%）[RR（95%CI）1.1（0.9-1.34）；P=0.35]。两组在需要第二次咪达唑仑剂量方面没有显著差异[44.4%比 55.6%；RR（95%CI）0.8（0.58-1.11）；P=0.18]，以及在 40 分钟时停止临床癫痫发作[96%比 92%；RR（95%CI）1.05（0.96-1.14）；P=0.49]和 24 小时内癫痫控制[85%比 76%；RR（95%CI）1.12（0.94-1.3）；P=0.21]。Lev-Mid 组有 3 名患者和 Pla-Mid 组有 6 名患者需要插管[RR（95%CI）0.5（0.13-1.92）；P=0.49]。在 24 小时的研究时间内，没有观察到其他不良反应或死亡。
与单独使用咪达唑仑相比，左乙拉西坦联合咪达唑仑在 20 分钟时停止临床癫痫发作没有显著优势。
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