% 0期刊文章%杰奎琳法国%帕特里克关颖珊% Toufic Fakhoury %一个凡尔纳皮特曼%一劳埃德·克纳普萨拉DuBrava % % Lorraine Yurkewicz % T与单药治疗部分性癫痫患者% B historical-controlled试验% D R 10.1212 / WNL 2014%。0000000000000119 % J首页神经病学% P 590 - 597 X % V 82% N 7%目的:评估与单药治疗部分性癫痫使用historical-controlled conversion-to-monotherapy设计。方法:成人控制不足部分性癫痫发作而收到1或2 8周期间使用抗癫痫药物潜在的基线被随机双盲单与600或150 mg / d(4:1) 20周(8周转换和12周的单药治疗期间)。主要终点是seizure-related退出率与600 mg / d,基于中断由于预定义的标准。功效被宣布如果上限95%置信区间的退出率低于74%的历史对照阈值,逐步评价使用阈值的68%。结果:试验后停止早期积极的功效临时分析125例。完整的研究人群包括161例,148可评价的有效性。癫痫诊断是14年以来的平均时间。总体而言,54.3% (600 mg / d)和46.9% (150 mg / d)的患者完成了20周的双盲治疗。Seizure-related退出率在600 mg / d组(27.5%;95%置信区间,17.8% - -37.2%)明显低于阈值的74%和68% (p < 0.001)。八个病人在600 mg / d和2 150 mg / d与单药治疗是控制发作。 Pregabalin's overall safety profile was consistent with prior trials.Conclusions: Pregabalin monotherapy was safe and efficacious for patients with inadequately controlled partial-onset seizures.Classification of evidence: This study provides Class III evidence that patients with inadequately controlled partial-onset seizures switched to pregabalin monotherapy have fewer seizure-related exit events compared with historical controls switched to pseudo-placebo monotherapy.AE=adverse event; AED=antiepileptic drug; CI=confidence interval; FDA=US Food and Drug Administration; IDMC=Independent Data Monitoring Committee; XR=extended release %U //www.ez-admanager.com/content/neurology/82/7/590.full.pdf