CTRS-INSERM IDEE, U821, Université Claude Bernard Lyon 1 and Neurological Hospital, Hospices Civils de Lyon, Lyon, France.
Eur J Neurol. 2010 May;17(5):726-32. doi: 10.1111/j.1468-1331.2009.02916.x. Epub 2010 Jan 25.
Pregabalin has demonstrated efficacy in controlled trials as adjunctive treatment in patients with refractory seizures.
This open-label, 21-week study in adults with at least two partial seizures in the last 2 months, who were inadequately controlled with one to three antiepileptic drugs, evaluated pregabalin 150-600 mg/day (dosed twice daily). The study comprised a prospective or retrospective 8-week baseline phase, and 9-week dose optimization and 12-week maintenance periods. The primary assessment was the mean percentage change in 28-day seizure frequency between baseline and end-point (last 12 weeks of treatment, last observation carried forward, modified intention-to-treat population).
Four hundred and seventy-six patients from Europe were included in this study (51% men; mean age/epilepsy duration 40.1/24.1 years). The median baseline seizure frequency was 5.5/28 days. Amongst the patient population, 78% completed the 21-week treatment period; 7% discontinued for lack of efficacy and 12% because of adverse events (AEs). The mean last pregabalin dose was 359 mg/day. The mean (95% CI) reduction in seizure frequency was 36% (31%; 41%). The median reduction was 33%, and 39% of patients had a >or=50% reduction in seizure frequency. There were 19% and 8% of patients free of seizures during their last 4 and 12 weeks of treatment, respectively. The three most common AEs were dizziness (17%), somnolence (13%) and weight increase (13%).
This open-label study of pregabalin demonstrated efficacy that was consistent with that observed in previous controlled epilepsy trials. Pregabalin was well tolerated. The AE profile was also consistent with that reported in previous trials.
普瑞巴林在对照试验中已被证明在难治性癫痫患者的辅助治疗中有效。
这项针对成人的开放性、21 周研究纳入了过去 2 个月中有至少 2 次部分性发作且用 1 至 3 种抗癫痫药物治疗仍控制不佳的患者，评估了普瑞巴林 150-600mg/天（每天 2 次给药）的疗效。该研究包括前瞻性或回顾性的 8 周基线期、9 周剂量优化期和 12 周维持期。主要评估指标是基线期和终点（治疗最后 12 周、最后一次观测到的结果向前结转、修改后的意向治疗人群）之间 28 天发作频率的平均百分比变化。
欧洲的 476 名患者入组了这项研究（51%为男性；平均年龄/癫痫持续时间为 40.1/24.1 年）。基线期发作频率中位数为 5.5/28 天。在患者人群中，78%完成了 21 周的治疗期；7%因疗效不佳而停药，12%因不良事件（AE）而停药。平均最后一次普瑞巴林剂量为 359mg/天。发作频率的平均（95%置信区间）降低了 36%（31%；41%）。中位数降低了 33%，39%的患者发作频率降低了≥50%。分别有 19%和 8%的患者在最后 4 周和 12 周的治疗期间无发作。最常见的 3 种 AE 是头晕（17%）、嗜睡（13%）和体重增加（13%）。
这项普瑞巴林开放性研究的疗效与之前的对照癫痫试验观察到的疗效一致。普瑞巴林的耐受性良好。AE 谱也与之前的试验报告一致。
