CIMA Centro Internacional de Medicina, Consultorio 16, Haciendas del Valle No 7120, Col Plaza Haciendas Chihuahua, Chihuahua 31238, Mexico.
Epilepsy Res. 2012 Jun;100(1-2):74-9. doi: 10.1016/j.eplepsyres.2012.01.009. Epub 2012 Feb 2.
To investigate the efficacy of pregabalin in the treatment of refractory partial seizures.
This was a 21-week, open-label study of pregabalin (150-600 mg/day) as an adjunctive therapy in adults with refractory partial seizures. The study included an 8-week baseline period, a 9-week dose-optimization period, and a 12-week treatment-observation period. The primary assessment was mean percentage change in 28-day seizure rate between baseline and the last 12 weeks of treatment.
In total, 136 Mexican patients were included in this study (55.9% women; mean age/epilepsy duration, 35.2/22.9 years). The median and mean (95% confidence interval [CI]) 28-day baseline seizure rates were 3.9 and 7.8 (5.4-10.2), respectively. The mean (95% CI) reduction in seizure frequency was 51.2% (43.0-59.3) over the last 12 weeks of treatment, while the median reduction was 57.9%. The percentage of patients with a ≥ 5 0% or ≥ 75% reduction in seizure frequency was 63.6% and 48.8%, respectively. The percentage of patients who were seizure-free during the last 4 and 12 weeks of treatment was 40.5% and 20.7%, respectively. The most common adverse events were somnolence (39.7%), dizziness (16.2%), and weight gain (14.0%).
Pregabalin was well tolerated and associated with significant reductions in seizure frequency.
研究普瑞巴林治疗耐药性部分性癫痫发作的疗效。
这是一项为期 21 周的开放性普瑞巴林(150-600mg/天)作为辅助治疗耐药性部分性癫痫发作的成人的研究。该研究包括 8 周的基线期、9 周的剂量优化期和 12 周的治疗观察期。主要评估指标为基线期至治疗后 12 周的 28 天发作率的平均百分比变化。
共有 136 名墨西哥患者纳入本研究(55.9%为女性;平均年龄/癫痫持续时间为 35.2/22.9 岁)。28 天基线发作率的中位数和平均值(95%置信区间[CI])分别为 3.9 和 7.8(5.4-10.2)。治疗后 12 周内,癫痫发作频率的平均(95%CI)降低了 51.2%(43.0-59.3),中位数降低了 57.9%。癫痫发作频率降低≥50%或≥75%的患者比例分别为 63.6%和 48.8%。在治疗的最后 4 周和 12 周内无癫痫发作的患者比例分别为 40.5%和 20.7%。最常见的不良反应是嗜睡(39.7%)、头晕(16.2%)和体重增加(14.0%)。
普瑞巴林耐受性良好,与癫痫发作频率的显著降低相关。