Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.
Advanced Pediatric Critical Care Center, Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, 600031, India.
Indian J Pediatr. 2020 Jul;87(7):512-519. doi: 10.1007/s12098-020-03221-2. Epub 2020 Feb 22.
To determine whether levetiracetam is an alternative to fosphenytoin to control Benzodiazepine Refractory Status Epilepticus (BRSE) in pediatric population and also to compare the acute drug related side-effects and ventilation requirement among the both arms of anti-epileptic drug therapy.
All consecutive children admitted with BRSE were randomized to group A, who received fosphenytoin at 20 mg/kg phenytoin equivalents (PE) dose and group B who received levetiracetam at 40 mg/kg over 10 min. Time to terminate seizure (response latency) was measured. If seizure remained refractory after 20 min of test drug administration, appropriate drug escalation was made according to pediatrician's discretion. All primary and secondary outcome measures were compared between the two therapeutic groups.
Of 61 children enrolled over 18 mo period, 29 (47.5%) were randomized to group A and 32 (52.5%) were randomized to Group B. Baseline characteristics were comparable between the two groups. Among 61 children, 58(98%) required Pediatric Intensive Care Unit (PICU) admission and among those 5(8.2%) children required mechanical ventilation. Duration of PICU stay, hospital stay, the response latency and seizure recurrence were compared between both groups. Significant number of children received additional anti-epileptic drugs (AEDs) in fosphenytoin group [9/29(31%)] compared to levetiracetam group [2/32(7%)] to control seizure.
Levetiracetam may be an effective alternative to fosphenytoin in management of BRSE in children but multicentric trials with large sample size are needed to substantiate this observation.
确定左乙拉西坦是否可替代苯妥英钠用于控制儿童人群中的苯二氮䓬类药物难治性癫痫持续状态（BRSE），并比较两种抗癫痫药物治疗方案的急性药物相关副作用和通气需求。
所有 BRSE 入院的连续儿童均随机分为 A 组，给予 20mg/kg 苯妥英钠当量（PE）剂量的苯妥英钠；B 组给予 40mg/kg 左乙拉西坦，10 分钟内输注完毕。测量终止癫痫发作的时间（反应潜伏期）。如果在试验药物给药 20 分钟后癫痫仍未得到控制，则根据儿科医生的判断进行适当的药物升级。比较两组治疗方案的所有主要和次要结局指标。
在 18 个月的研究期间，共纳入 61 名儿童，其中 29 名（47.5%）随机分入 A 组，32 名（52.5%）随机分入 B 组。两组基线特征相似。61 名儿童中，58 名（98%）需要入住儿科重症监护病房（PICU），其中 5 名（8.2%）需要机械通气。比较两组间 PICU 住院时间、住院时间、反应潜伏期和癫痫复发率。与左乙拉西坦组相比，苯妥英钠组有更多的儿童需要额外使用抗癫痫药物（AEDs）[9/29（31%）]来控制癫痫发作。
左乙拉西坦可能是苯二氮䓬类药物难治性癫痫持续状态患儿的有效替代药物，但需要进行多中心、大样本量的临床试验来证实这一观察结果。
