Wheless James W, Neto Walter, Wang Steven
Department of Neurology, University of Texas Health Science Center at Houston, Houston, TX, USA.
J Child Neurol. 2004 Feb;19(2):135-41. doi: 10.1177/08830738040190020901.
In a novel double-blind trial, topiramate was compared with the investigator's choice of carbamazepine or valproate as first-line therapy in patients as young as 6 years of age with newly diagnosed epilepsy. Among 613 patients enrolled in the trial, 119 (19%) were children or adolescents (6-16 years of age). No differences between fixed doses of topiramate (100 and 200 mg/day) and carbamazepine (600 mg/day) or valproate (1250 mg/day) were observed in efficacy measures: time to exit, time to first seizure, and the proportion of patients who were seizure free during the last 6 months of treatment. Topiramate 100 mg/day (2.0 mg/kg/day in this study population) was associated with the fewest discontinuations owing to side effects. Based on efficacy and tolerability, the recommended target dose for topiramate as first-line therapy in children and adolescents is 100 mg/day.
在一项新型双盲试验中,将托吡酯与研究者选择的卡马西平或丙戊酸盐作为一线疗法,用于6岁及以上新诊断癫痫患者。在该试验纳入的613例患者中,119例(19%)为儿童或青少年(6至16岁)。在疗效指标方面,未观察到固定剂量的托吡酯(100和200毫克/天)与卡马西平(600毫克/天)或丙戊酸盐(1250毫克/天)之间存在差异:退出时间、首次发作时间以及治疗最后6个月无癫痫发作患者的比例。托吡酯100毫克/天(本研究人群中为2.0毫克/千克/天)因副作用导致的停药最少。基于疗效和耐受性,托吡酯作为儿童和青少年一线疗法的推荐目标剂量为100毫克/天。