Gil-Nagel A, Lopes-Lima J, Almeida L, Maia J, Soares-da-Silva P
Hospital Ruber Internacional, Mirasierra, Madrid, Spain.
Acta Neurol Scand. 2009 Nov;120(5):281-7. doi: 10.1111/j.1600-0404.2009.01218.x.
To evaluate the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures.
Double-blind, placebo-controlled, parallel-group, multicenter study consisting of an 8-week baseline period, after which patients were randomized to placebo (n = 87) or once-daily ESL 800 mg (n = 85) or 1200 mg (n = 80). Patients received half dose during 2 weeks preceding a 12-week maintenance period.
Seizure frequency over the maintenance period was significantly (P < 0.05) lower than placebo in both ESL groups. Responder rate was 23% (placebo), 35% (800 mg), and 38% (1200 mg). Median relative reduction in seizure frequency was 17% (placebo), 38% (800 mg), and 42% (1200 mg). The most common adverse events (AEs) (>10%) were dizziness, somnolence, headache, and nausea. The majority of AEs were of mild or moderate severity.
Once-daily treatment with ESL 800 and 1200 mg was effective and generally well tolerated.
评估醋酸艾司利卡西平（ESL）作为辅助治疗药物用于成人部分性发作癫痫的疗效和安全性。
双盲、安慰剂对照、平行组、多中心研究，包括为期8周的基线期，之后患者被随机分为安慰剂组（n = 87）、每日一次800 mg ESL组（n = 85）或1200 mg ESL组（n = 80）。在为期12周的维持期前2周，患者接受半剂量治疗。
在两个ESL组中，维持期的癫痫发作频率均显著低于安慰剂组（P < 0.05）。有效率分别为23%（安慰剂组）、35%（800 mg组）和38%（1200 mg组）。癫痫发作频率的中位数相对降低率分别为17%（安慰剂组）、38%（800 mg组）和42%（1200 mg组）。最常见的不良事件（>10%）为头晕、嗜睡、头痛和恶心。大多数不良事件为轻度或中度。
每日一次服用800 mg和1200 mg的ESL有效且总体耐受性良好。
