左乙拉西坦作为二线药物与磷苯妥英治疗儿童惊厥性癫痫持续状态的比较:一项单中心、开放标签随机对照试验

S. Anupama, V. Poovazhagi, R. Nisha, S. Kumar, J. Sathya
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引用次数: 1

摘要

背景:癫痫持续状态(SE)是儿童年龄组最常见的神经系统急症,通常严重且危及生命。虽然使用了较新的药物,但发病率和死亡率仍然很高。本研究的目的是比较左乙曲坦与现有二线药物磷妥英治疗SE的疗效。研究对象和方法:这是一项来自某三级医疗机构儿科重症监护病房的前瞻性、随机平行组试验。按纳入和排除标准招募100名儿童,磷苯妥英组50名,左乙拉西坦组50名。比较两组患者癫痫发作的临床停止、复发、不良事件和结局。结果:男女比例为1.45:1。磷酸苯妥英组37例(74%)癫痫发作得到控制,左乙拉西坦组28例(56%)癫痫发作得到控制(P = 0.059)。两组患者癫痫发作停止的平均时间分别为11.16±3.58 min和12.78±3.07 min,差异有统计学意义(P = 0.059)。两组患者癫痫发作前24 h复发率(18[36%]比12[24%])和休克发生率(14[28%]比11[22%])差异有统计学意义(P = 0.488)。磷妥英组总死亡率为10(20%),而左乙拉西坦组总死亡率为7 (14%)(P = 0.281)。结论:左乙拉西坦作为治疗儿童惊厥性SE的二线药物,其疗效与磷苯妥英相当。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of levetiracetam as second-line drug with fosphenytoin in convulsive status epilepticus among children: A single center, open-label randomized controlled trial
Background: Status epilepticus (SE) is the most common neurologic emergency in the pediatric age group often serious and life-threatening. Although newer drugs were used, morbidity and mortality are still high. This study was done to compare the efficacy of levetiracetam with the existing second-line drug fosphenytoin in the treatment of SE. Subjects and Methods: This was a prospective, randomized parallel group trial from Pediatric Intensive Care Unit of a Tertiary Care Institute. One hundred children were recruited according to the inclusion and exclusion criteria, 50 in fosphenytoin group and 50 in levetiracetam group. Two groups were compared with respect to clinical cessation of seizures, recurrence, adverse event, and outcome. Results: Male-to-female ratio was 1.45:1. Seizure were controlled in 37 (74%) in fosphenytoin group and 28 (56%) in levetiracetam group) (P = 0.059). The mean time for cessation of seizures was 11.16 ± 3.58 min in fosphenytoin group as compared to was 12.78 ± 3.07 min in levetiracetam group (P = 0.059) The seizure recurrence in first 24 h (18 [36%] vs. 12 [24%]) (P = 0.643) and development of shock (14 [28%] vs. 11 [22%]) (P = 0.488) was comparable in two groups. Overall mortality was 10 (20%) in fosphenytoin group as compared to 7 (14%) levetiracetam group (P = 0.281). Conclusions: Efficacy of intravenous levetiracetam is comparable to fosphenytoin as a second-line medication in the management of convulsive SE in children.
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