Hopital Pitié-Salpêtrière, APHP, Universite PARIS VI and INSERM UMR_S 975, Cortex & Epilepsy, Clinique Neurologique, Hopital de la Pitié-Salpêtrière, Paris, France.
Epilepsy Res. 2010 Sep;91(1):10-9. doi: 10.1016/j.eplepsyres.2010.05.008. Epub 2010 Aug 8.
This study assessed the comparative efficacy of pregabalin for refractory partial seizures.
Four-hundred and thirty-four patients with partial seizures were randomized to pregabalin, lamotrigine, or placebo as adjunctive therapy for 17 weeks of double-blind treatment. In phase I (11 weeks), pregabalin was titrated over 1 week and lamotrigine over 5 weeks to fixed dosages of 300mg/day for both. In phase II (6 weeks), patients not yet seizure-free were increased to pregabalin 600mg/day or lamotrigine 400mg/day.
During phase I, there was a nonsignificant trend toward a greater reduction in seizures with pregabalin versus placebo and lamotrigine. Across the 17 weeks of treatment, pregabalin showed a median percentage reduction from baseline in seizure frequency of -20.0% (p=.001) versus placebo, and -9.7% (p=.080) versus lamotrigine. The responder rate (> or =50% reduction in seizure frequency) for pregabalin exceeded that of placebo (36% vs 21%; p=.007) and lamotrigine (36% vs 24%; p=.04). Adverse events were consistent with the known safety profiles of pregabalin and lamotrigine.
Pregabalin was demonstrated to be noninferior to lamotrigine in the treatment of refractory partial seizures. Overall conclusions were complicated by an unusually large and heterogeneous placebo response.
本研究评估了普瑞巴林治疗耐药性部分性癫痫发作的疗效。
434 例部分性癫痫发作患者随机分为普瑞巴林组、拉莫三嗪组或安慰剂组，作为辅助治疗进行为期 17 周的双盲治疗。在第 I 阶段（11 周），普瑞巴林在 1 周内滴定，拉莫三嗪在 5 周内滴定至固定剂量 300mg/天。在第 II 阶段（6 周），未达到无发作的患者将剂量增加至普瑞巴林 600mg/天或拉莫三嗪 400mg/天。
在第 I 阶段，与安慰剂和拉莫三嗪相比，普瑞巴林在减少癫痫发作方面有一个非显著的趋势。在 17 周的治疗期间，普瑞巴林显示出从基线的中位数癫痫发作频率降低 20.0%（p=0.001），与安慰剂相比，降低 9.7%（p=0.080），与拉莫三嗪相比。普瑞巴林的应答率（频率降低≥50%）超过安慰剂（36%比 21%；p=0.007）和拉莫三嗪（36%比 24%；p=0.04）。不良事件与普瑞巴林和拉莫三嗪已知的安全性特征一致。
普瑞巴林在治疗耐药性部分性癫痫发作方面被证明与拉莫三嗪等效。总体结论因异常大的安慰剂反应而变得复杂。
