Curatolo P, Bruni O, Brindesi I, Pruna D, Cusmai R
Riv Neurol. 1986 Jan-Feb;56(1):25-38.
Therapeutic effects of flunarizine have been studied on 26 patients, aged from 9 months to 17 years, suffering for epilepsies resistant to common anticonvulsant treatment, despite proper plasmatic levels of drugs. All the cases were monitored with monthly clinical and EEG controls, neuropsychological evaluations and monitoring antiepileptic drugs plasmatic levels. At first, a study was performed on an intra-patient basis: after a basal observation during two months, an open clinical trial was started, using for three months flunarizine 5 mg a day in patients weighing over 10 kg, and 5 mg every two days in children weighing less than 10 kg. Later on, a simple blind clinical trial has been performed on 16 patients, using flunarizine or placebo for three months. The results, obtained in resistant epilepsy of children and adolescent, showed that flunarizine induced in 47.6% of cases a significant reduction of critical (stroke) frequency and intensity, together with normalization of sleeping-waking rhythm, and amelioration of attention performances (vigilance, reactivity, environmental participation). The only side-effect, noticed in 23.8% of cases, was a light diurnal sleepiness, spontaneously regressing after a few days of treatment.
对26例年龄在9个月至17岁之间、患有对常用抗惊厥治疗耐药的癫痫症（尽管药物血浆水平正常）的患者进行了氟桂利嗪的治疗效果研究。所有病例每月进行临床和脑电图检查、神经心理学评估以及监测抗癫痫药物血浆水平。首先，在患者个体基础上进行了一项研究：在两个月的基础观察期后，开始了一项开放临床试验，体重超过10公斤的患者每天使用5毫克氟桂利嗪，体重不足10公斤的儿童每两天使用5毫克，为期三个月。随后，对16例患者进行了一项简单的盲法临床试验，使用氟桂利嗪或安慰剂，为期三个月。在儿童和青少年耐药性癫痫中获得的结果表明，氟桂利嗪在47.6%的病例中使临界（发作）频率和强度显著降低，同时使睡眠-觉醒节律正常化，并改善了注意力表现（警觉性、反应性、环境参与度）。在23.8%的病例中观察到的唯一副作用是轻度日间嗜睡，在治疗几天后自行消退。
