Albsoul-Younes Abla M, Salem Hazem A, Ajlouni Saleh F, Al-Safi Saafan A
Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan.
Pediatr Neurol. 2004 Nov;31(5):349-52. doi: 10.1016/j.pediatrneurol.2004.04.012.
Topiramate is an effective treatment for several types of seizures. The aim of this study is to assess the efficacy and tolerability of slow topiramate dose titration as add-on therapy in childhood epilepsy. This investigation is a prospective open-label, single-center, add-on study in 22 children with a diagnosis of refractory epilepsy. Topiramate (dose 0.5-2 mg/kg/day) was titrated at 2-week intervals up to the recommended dose of 6-12 mg/kg/day. Seizure frequency rate reduction was significant, declining from 23 +/- 5.1 seizures/week (mean +/- S.E.M.) at baseline phase to 3.5 +/- 1.2 seizures/week at the end of the 16-week stabilization phase (P < 0.001). After 16 weeks of stabilization, 19 patients (86%) had more than 50% seizure reduction. Seven patients (31%) were 100% seizure-free. Two patients (9%) manifested no improvement; only one patient (5%) did not tolerate the added drug and discontinued topiramate. One patient manifested severe side effects, whereas 21 patients experienced mild to moderate side effects mostly represented by somnolence, nervousness, and anorexia with or without weight loss. We conclude that slow dose titration improves efficacy and tolerability of topiramate as add-on therapy in the treatment in refractory epilepsy.
托吡酯是治疗多种类型癫痫发作的有效药物。本研究旨在评估托吡酯缓慢滴定剂量作为儿童癫痫附加疗法的疗效和耐受性。本调查是一项前瞻性开放标签、单中心的附加研究，纳入了22例诊断为难治性癫痫的儿童。托吡酯（剂量为0.5 - 2mg/kg/天）每隔2周滴定一次，直至推荐剂量6 - 12mg/kg/天。癫痫发作频率显著降低，从基线期的23±5.1次/周（平均值±标准误）降至16周稳定期结束时的3.5±1.2次/周（P < 0.001）。在16周的稳定期后，19例患者（86%）癫痫发作减少超过50%。7例患者（31%）癫痫完全缓解。2例患者（9%）无改善；只有1例患者（5%）不能耐受加用的药物并停用了托吡酯。1例患者出现严重副作用，而21例患者经历了轻度至中度副作用，主要表现为嗜睡、紧张和厌食，伴或不伴有体重减轻。我们得出结论，缓慢滴定剂量可提高托吡酯作为附加疗法治疗难治性癫痫的疗效和耐受性。
