Abbaskhanian Ali, Sadeghi Hamid Reza, Erfani Ali, Rezai Mohammad Sadegh
Department of Pediatrics, Booali Sina Hospital, Sari, Iran.
J Pediatr Neurosci. 2012 Sep;7(3):171-4. doi: 10.4103/1817-1745.106470.
Migraine is a common neurological disorder in childhood and adolescence. Topiramate is a new anticonvulsant drug, recently being used in migraine prophylaxis in adults, although it is not approved by the Food and Drug Administration for prevention of pediatric migraine. The present study was planned and performed to evaluate the efficacy of low-dose topiramate in pediatric migraine prophylaxis.
A prospective study, including 60 patients with migraine headaches was performed for a period of two months. The patients were randomly divided into two treatment groups - treated by topiramate < 2 mg/kg/day and > 2 mg/kg/day. All the patients were evaluated at 0, 4, and 8 weeks of the study for the clinical response.
The patients receiving topiramate < 2 mg/kg/day (mean dose of 1.2 ± 0.7 mg/kg/day) showed a reduction in the mean (±SD) of migraine frequency from 6.2 (±2.4) to 3.0 (±1.8) episodes per month, headache intensity from 7.2 (±1.95) to 3.7 (±1.8) based on the Visual Analog Scale, and headache duration from 5.4 (±2.1) to 2.2 (±1.3) h. In the patients treated with topiramate > 2 mg/kg/day (mean dose of 2.4 ± 0.5 mg/kg/day), the mean (±SD) of monthly headache frequency reduced from 6.9 (±2.1) to 3.24 (±1.2) per month, intensity from 7.11 (±1.4) to 3.14 (±2.41), and headache duration from 5.2 (±2.4) to 1.8 (±1.2) h, at the end of follow-up (P > 0.05). The most common side effects of topiramate were paresthesias (five patients), anorexia (four patients), drowsiness (four patients).
The results of this study demonstrated that low-dose of topiramate (<2 mg/kg/day) is effective, well-tolerated, safe, and suggested as an alternative prophylactic treatment for pediatric migraine.
偏头痛是儿童和青少年期常见的神经系统疾病。托吡酯是一种新型抗惊厥药物,虽未获美国食品药品监督管理局批准用于预防儿童偏头痛,但最近已用于成人偏头痛的预防。本研究旨在评估低剂量托吡酯预防儿童偏头痛的疗效。
进行了一项为期两个月的前瞻性研究,纳入60例偏头痛患儿。患者被随机分为两个治疗组,分别接受<2mg/kg/天和>2mg/kg/天的托吡酯治疗。在研究的第0、4和8周对所有患者的临床反应进行评估。
接受<2mg/kg/天托吡酯治疗的患者(平均剂量为1.2±0.7mg/kg/天),每月偏头痛发作次数的平均值(±标准差)从6.2(±2.4)次降至3.0(±1.8)次,根据视觉模拟量表,头痛强度从7.2(±1.95)降至3.7(±1.8),头痛持续时间从5.4(±2.1)小时降至2.2(±1.3)小时。接受>2mg/kg/天托吡酯治疗的患者(平均剂量为2.4±0.5mg/kg/天),随访结束时每月头痛发作次数的平均值(±标准差)从6.9(±2.1)降至3.24(±1.2)次,强度从7.11(±1.4)降至3.14(±2.41),头痛持续时间从5.2(±2.4)小时降至1.8(±1.2)小时(P>0.05)。托吡酯最常见的副作用为感觉异常(5例患者)、厌食(4例患者)、嗜睡(4例患者)。
本研究结果表明,低剂量托吡酯(<2mg/kg/天)有效、耐受性良好且安全,可作为儿童偏头痛预防性治疗的一种替代选择。