Service de Neurologie et d'Epileptologie, Hôpital Neurologique, Hospices Civils de Lyon, Université Lyon 1, INSERM U821 and CTRS-IDEE, Lyon, France.
Neuropsychiatr Dis Treat. 2008 Dec;4(6):1211-24. doi: 10.2147/ndt.s4716.
Pregabalin is one of the latest antiepileptic drugs introduced for the treatment of partial epilepsy. Its efficacy and safety as adjunctive therapy in refractory partial epilepsy have been established in four double-blind placebo-controlled trials (n = 1396) and 4 long-term open-label studies (n = 1480). In 3 fixed-dose trials, the proportion of patients with a >/=50% reduction in seizure frequency across the effective dose-range (150-600 mg/day) ranged between 14% and 51%, with a clear dose-response relationship. Suppression of seizure activity could be demonstrated as early as day 2. The most frequently reported CNS-related adverse events included dizziness, somnolence, ataxia and fatigue, were usually mild or moderate, and tended to be dose related. In long-term studies, weight gain was reported as an adverse event by 24% of patients. When pregabalin dose was individualized to according to response within the 150 to 600 mg/day dose range, tolerability was considerably improved compared with use of a high-dose, fixed-dose regimen (600 mg/day) without titration. In long-term studies up to 4 years, no evidence of loss efficacy was identified. During the last year on pregabalin, 3.7% of patients were seizure-free. Pregabalin appears to be a useful addition to the therapeutic armamentariun for the management of refractory partial epilepsy.
普瑞巴林是最新引入的抗癫痫药物之一，用于治疗部分性癫痫。四项双盲安慰剂对照试验（n = 1396）和四项长期开放性研究（n = 1480）已证实其作为难治性部分性癫痫辅助治疗的疗效和安全性。在三项固定剂量试验中，有效剂量范围内（150-600mg/天），发作频率减少≥50%的患者比例在 14%至 51%之间，存在明确的剂量反应关系。在第 2 天即可显示出抑制发作活动的作用。最常报告的与中枢神经系统相关的不良事件包括头晕、嗜睡、共济失调和疲劳，通常为轻度或中度，且与剂量有关。在长期研究中，24%的患者报告体重增加为不良事件。与不滴定的高剂量、固定剂量方案（600mg/天）相比，根据 150 至 600mg/天剂量范围内的反应个体化调整普瑞巴林剂量可显著提高耐受性。在长达 4 年的长期研究中，未发现疗效丧失的证据。在服用普瑞巴林的最后一年，3.7%的患者无发作。普瑞巴林似乎是治疗难治性部分性癫痫的一种有效治疗方法。
