Czapiński P, Terczyński A
Klinika Neurologii Collegium Medicum UJ w Krakowie.
Neurol Neurochir Pol. 1996 May-Jun;30(3):419-26.
An open randomized comparative study was carried out on the efficacy and tolerance of carbamazepine--Tegretol CR (CBZ) and sodium valproate--Depakine chrono (VPA) in adult patients with newly diagnosed epilepsy with partial complex seizures with or without secondary generalization. The trial included 60 patients aged 18-50 years. Thirty patients were randomized to an initial CBZ dose of 2 x 200 mg daily, and the remaining 30 patients to an initial VPA dose of 2 x 300 mg daily. The follow-up was carried out for 3 years. If clinically necessary, the doses were increased while monitoring blood serum drug levels until the therapeutic effect was achieved or side effects developed. A maximum dose of CBZ was established at 2000 mg/day, and that of VPA at 3000 mg/day. Within the first 6 months of the therapy, 5 patients on CBZ (16.6%) and 2 patients on VPA (6.6%) were excluded from the trial due to poor seizure control or adverse side effects. Between the seventh month and the end of the third year of the study, the number of patients additionally excluded for the above reasons was 5 (16.6%) individuals on CBZ and 6 (20%) patients on VPA. Out of the patients who were followed up for 3 years, 16 (80%) on CBZ and 16 (72.7%) on VPA achieved 12-month remission, while 12 patients on CBZ (60%) and 13 (59%) on VPA achieved a 24-month remission. It can be thus concluded, that the patients administered CBZ achieved the remission faster than the patients on VPA, but after 3-year therapy the effectiveness of the two drugs was comparable. There was no difference in effectiveness between patients with partial complex seizures with and without secondary generalization. The number of patients with adverse effects in both groups was comparable.
对卡马西平（得理多控释片，CBZ）和丙戊酸钠（德巴金缓释片，VPA）在新诊断的伴有或不伴有继发性全身性发作的部分性复杂发作成年癫痫患者中的疗效和耐受性进行了一项开放性随机对照研究。该试验纳入了60名年龄在18至50岁之间的患者。30名患者被随机分配至初始CBZ剂量为每日2×200mg，其余30名患者被分配至初始VPA剂量为每日2×300mg。随访为期3年。如有临床必要，在监测血清药物水平的同时增加剂量，直至达到治疗效果或出现副作用。CBZ的最大剂量设定为2000mg/天，VPA的最大剂量设定为3000mg/天。在治疗的前6个月内，5名服用CBZ的患者（16.6%）和2名服用VPA的患者（6.6%）因癫痫控制不佳或出现不良反应而被排除出试验。在研究的第7个月至第3年末，因上述原因额外被排除的患者数量为服用CBZ的5名（16.6%）个体和服用VPA的6名（20%）患者。在接受3年随访的患者中，服用CBZ的16名（80%）和服用VPA的16名（72.7%）实现了12个月缓解，而服用CBZ的12名患者（60%）和服用VPA的13名（59%）实现了24个月缓解。由此可以得出结论，服用CBZ的患者比服用VPA的患者缓解更快，但经过3年治疗后，两种药物的有效性相当。伴有和不伴有继发性全身性发作的部分性复杂发作患者之间的有效性没有差异。两组中出现不良反应的患者数量相当。
