Department of Pediatrics, Chinese PLA General Hospital Beijing, 100583, China ; Department of Pediatrics, Chinese PLA General Hospital Beijing, 100583, China.
Department of Neurology, Jiang-Xi Children's Hospital Jiangxi, 330006, China.
Ann Clin Transl Neurol. 2014 Mar;1(3):171-9. doi: 10.1002/acn3.34. Epub 2014 Feb 24.
Febrile seizure (FS) is the most common form of childhood seizure disorders. FS is perhaps one of the most frequent causes of admittance to pediatric emergency wards worldwide. We aimed to identify a new, safe, and effective therapy for preventing FS recurrence.
A total of 115 children with a history of two or more episodes of FS were randomly assigned to levetiracetam (LEV) and control (LEV/control ratio = 2:1) groups. At the onset of fever, LEV group was orally administered with a dose of 15-30 mg/kg per day twice daily for 1 week. Thereafter, the dosage was gradually reduced until totally discontinued in the second week. The primary efficacy variable was seizure frequency associated with febrile events and FS recurrence rate (RR) during 48-week follow-up. The second outcome was the cost effectiveness of the two groups.
The intention-to-treat analysis showed that 78 children in LEV group experienced 148 febrile episodes. Among these 78 children, 11 experienced 15 FS recurrences. In control group, 37 children experienced 64 febrile episodes; among these 37 children, 19 experienced 32 FS recurrences. A significant difference was observed between two groups in FS RR and FS recurrence/fever episode. The cost of LEV group for the prevention of FS recurrence is lower than control group. During 48-week follow-up period, one patient in LEV group exhibited severe drowsiness. No other side effects were observed in the same patient and in other children.
Intermittent oral LEV can effectively prevent FS recurrence and reduce wastage of medical resources.
热性惊厥（FS）是儿童惊厥障碍中最常见的形式。FS 可能是全球儿科急诊病房最常见的入院原因之一。我们旨在寻找一种新的、安全有效的治疗方法，以预防 FS 复发。
共有 115 名有两次或两次以上 FS 发作史的儿童被随机分配到左乙拉西坦（LEV）和对照组（LEV/对照组比例为 2:1）。发热时，LEV 组口服 15-30mg/kg/天，每日两次，持续 1 周。然后逐渐减少剂量，第二周完全停药。主要疗效变量是发热相关的发作频率和 48 周随访期间 FS 的复发率（RR）。第二个结果是两组的成本效益。
意向治疗分析显示，LEV 组 78 名儿童有 148 次发热发作。这 78 名儿童中，11 名发生 15 次 FS 复发。对照组 37 名儿童有 64 次发热发作；这 37 名儿童中，19 名发生 32 次 FS 复发。两组间 FS RR 和 FS 复发/发热发作率有显著差异。LEV 组预防 FS 复发的成本低于对照组。在 48 周的随访期间，LEV 组有 1 名患者出现严重嗜睡。同一患者和其他儿童未观察到其他不良反应。
间断口服 LEV 能有效预防 FS 复发，减少医疗资源浪费。
