Beydoun A, Uthman B M, Kugler A R, Greiner M J, Knapp L E, Garofalo E A
University of Michigan Health System, 1500 E. Medical Center Dr., UH 1 B 300/0036, Ann Arbor, MI 48109-0036, USA.
Neurology. 2005 Feb 8;64(3):475-80. doi: 10.1212/01.WNL.0000150932.48688.BE.
To evaluate the efficacy, tolerability, and safety of two pregabalin regimens administered as adjunctive therapy to that of placebo in patients with medically refractory partial epilepsy.
A multicenter, double-blind, randomized, parallel-group, placebo-controlled trial was performed. Following a prospective 8-week baseline phase, patients were randomized to 12 weeks of double-blind treatment with placebo or pregabalin 600 mg/day administered twice daily (BID) or three times daily (TID). Primary efficacy was measured as change in seizure frequency from baseline of either pregabalin regimen compared with placebo. Secondary efficacy comparisons included the proportion of patients experiencing > or =50% reduction in seizure frequency (responder rate) and median percentage change from baseline in seizure frequency. Safety/tolerability assessments included adverse events (AEs), physical and neurologic examinations, and clinical laboratory evaluation. Efficacy and safety analyses were performed on the intent-to-treat (ITT) population.
Pregabalin treatment resulted in seizure frequency reductions: 53% for pregabalin TID (p < or = 0.0001) and 44% for pregabalin BID (p < or = 0.0001) compared with a 1% increase for placebo. Responder rates were 49% for pregabalin TID and 43% for pregabalin BID compared with 9% for placebo (p < or = 0.001). Both pregabalin regimens were similar in efficacy and tolerability. The most common AEs were dizziness, somnolence, and ataxia.
Pregabalin administered at 600 mg/day is safe, generally well tolerated, and efficacious as adjunctive therapy for the treatment of patients with partial seizures, with or without secondary generalizations. This dose can be administered on a twice daily or three times daily schedule with similar efficacy and tolerability results.
评估两种加巴喷丁治疗方案作为辅助治疗对药物难治性部分性癫痫患者的疗效、耐受性及安全性，以安慰剂作为对照。
进行一项多中心、双盲、随机、平行组、安慰剂对照试验。在为期8周的前瞻性基线期之后，患者被随机分配接受为期12周的双盲治疗，治疗方案为安慰剂或加巴喷丁600mg/天，每日两次（BID）或每日三次（TID）。主要疗效指标为与安慰剂相比，两种加巴喷丁治疗方案从基线开始的癫痫发作频率变化。次要疗效比较包括癫痫发作频率降低≥50%的患者比例（缓解率）以及癫痫发作频率相对于基线的中位百分比变化。安全性/耐受性评估包括不良事件（AE）、体格检查和神经系统检查以及临床实验室评估。疗效和安全性分析在意向性治疗（ITT）人群中进行。
与安慰剂组癫痫发作频率增加1%相比，加巴喷丁治疗使癫痫发作频率降低：加巴喷丁TID组降低53%（p≤0.0001），加巴喷丁BID组降低44%（p≤0.0001）。加巴喷丁TID组的缓解率为49%，加巴喷丁BID组为43%，而安慰剂组为9%（p≤0.001）。两种加巴喷丁治疗方案在疗效和耐受性方面相似。最常见的不良事件为头晕、嗜睡和共济失调。
每天服用600mg加巴喷丁作为辅助治疗药物难治性部分性癫痫患者，无论是否伴有继发性全身性发作，均安全、耐受性良好且有效。该剂量可每日服用两次或三次，疗效和耐受性结果相似。
