Leppik I E, Dreifuss F E, Pledger G W, Graves N M, Santilli N, Drury I, Tsay J Y, Jacobs M P, Bertram E, Cereghino J J
Department of Neurology, University of Minnesota, Minneapolis.
Neurology. 1991 Nov;41(11):1785-9. doi: 10.1212/wnl.41.11.1785.
Felbamate (2-phenyl-1,3-propanediol dicarbamate) has a favorable preclinical profile in animal models of epilepsy. We present the results of a double-blind, randomized, placebo-controlled clinical trial in patients with partial seizures. Criteria for entry included a requirement for four or more partial seizures per month despite concomitant therapeutic blood levels of phenytoin and carbamazepine. Fifty-six patients (mean age, 31.4 years; 32 men, 24 women) completed the trial. The mean seizure frequencies for the 8-week periods analyzed were felbamate = 34.9, placebo = 40.2. Felbamate was statistically superior to placebo in seizure reduction, percent seizure reduction, and truncated percent seizure reduction. The mean felbamate dosage was 2,300 mg/d. Plasma felbamate concentrations ranged from 18.4 to 51.9 mg/l, mean = 32.5 mg/l. Adverse experiences during felbamate therapy were minor and consisted primarily of nausea and CNS effects. This trial indicates that felbamate is safe and effective in the treatment of comedicated patients with severely refractory epilepsy.
非氨酯（2-苯基-1,3-丙二醇二氨基甲酸酯）在癫痫动物模型中具有良好的临床前表现。我们公布了一项针对部分性癫痫患者的双盲、随机、安慰剂对照临床试验的结果。入选标准包括尽管苯妥英和卡马西平的治疗血药浓度正常，但每月仍有四次或更多次部分性癫痫发作。56名患者（平均年龄31.4岁；男性32名，女性24名）完成了试验。分析的8周期间的平均癫痫发作频率为：非氨酯组=34.9次，安慰剂组=40.2次。在癫痫发作减少、癫痫发作减少百分比和截短癫痫发作减少百分比方面，非氨酯在统计学上优于安慰剂。非氨酯的平均剂量为2300毫克/天。血浆非氨酯浓度范围为18.4至51.9毫克/升，平均=32.5毫克/升。非氨酯治疗期间的不良事件轻微，主要包括恶心和中枢神经系统影响。该试验表明，非氨酯在治疗联合用药的严重难治性癫痫患者中是安全有效的。
