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一项在墨西哥多个中心进行的为期 21 周的、开放性标签的、关于普瑞巴林作为部分发作附加治疗的临床试验(PREPS Mexico)。

A 21-week open-label clinical trial of pregabalin as adjunctive therapy in partial seizures at multiple centers in Mexico (PREPS Mexico).

机构信息

CIMA Centro Internacional de Medicina, Consultorio 16, Haciendas del Valle No 7120, Col Plaza Haciendas Chihuahua, Chihuahua 31238, Mexico.

出版信息

Epilepsy Res. 2012 Jun;100(1-2):74-9. doi: 10.1016/j.eplepsyres.2012.01.009. Epub 2012 Feb 2.

DOI:10.1016/j.eplepsyres.2012.01.009
PMID:22304935
Abstract

PURPOSE

To investigate the efficacy of pregabalin in the treatment of refractory partial seizures.

METHODS

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.

RESULTS

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%).

CONCLUSION

Pregabalin was well tolerated and associated with significant reductions in seizure frequency.

摘要

目的

研究普瑞巴林治疗耐药性部分性癫痫发作的疗效。

方法

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。

结果

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%)。

结论

普瑞巴林耐受性良好,与癫痫发作频率的显著降低相关。

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