Rocamora Rodrigo, Álvarez Ion, Chavarría Beatriz, Principe Alessandro
Epilepsy Monitoring Unit, Department of Neurology, Hospital del Mar Medical Research Institute, Carrer Aiguader, 88, 08003, Barcelona, Spain; Faculty of Health and Life Sciences, Universitat Pompeu Fabra, Barcelona, Spain.
Epilepsy Monitoring Unit, Department of Neurology, Hospital del Mar Medical Research Institute, Carrer Aiguader, 88, 08003, Barcelona, Spain.
Seizure. 2020 Feb 10;76:137-142. doi: 10.1016/j.seizure.2020.01.021.
Among patients with epilepsy, sleep disturbances can worsen seizure control. This prospective open-label study determined the effect of the antiepileptic drug perampanel on sleep architecture in patients with refractory epilepsy.
Adult patients with refractory epilepsy received add-on perampanel, starting at 2 mg/day at bedtime, increased by 2 mg after 2 weeks and then monthly until the target dose of 4-8 mg/day was reached. The median dose of perampanel used was 6 mg (SD 1.2). Polysomnographic (PSG) recordings were scheduled 1 week before starting perampanel and the control PSG after 12 weeks under perampanel treatment and at least 4 weeks on stable perampanel dose; patients completed the Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI) questionnaires. The main endpoints were change from baseline in the ESS and PSQI scores, and PSG variables.
Of 25 patients included (aged 18-65 years, 56 % female) only 17 completed the study. Perampanel caused a modest decrease from baseline in mean ESS score (n = 13 patients; p = 0.126) and PSQI score (n = 12 patients; p = 0.127). Treatment significantly improved sleep parameters (n = 17 patients) including total sleep time (p = 0.037), sleep latency (p = 0.022), sleep efficiency (p = 0.015), sleep maintenance index (p = 0.005), wake time after sleep onset (p = 0.015), and duration of N3 sleep stage (p = 0.026). Patients with altered sleep efficiency parameters at baseline showed a significant increase in sleep maintenance index (p = 0.015), and 77.8 % achieved sleep efficiency >85 % (p = 0.016 vs baseline).
Perampanel improved sleep architecture in patients with focal refractory epilepsy without worsening daytime sleepiness.
在癫痫患者中，睡眠障碍会使癫痫控制情况恶化。这项前瞻性开放标签研究确定了抗癫痫药物吡仑帕奈对难治性癫痫患者睡眠结构的影响。
成年难治性癫痫患者接受吡仑帕奈附加治疗，起始剂量为睡前2毫克/天，2周后增加至2毫克，之后每月增加一次，直至达到目标剂量4 - 8毫克/天。使用的吡仑帕奈中位剂量为6毫克（标准差1.2）。在开始使用吡仑帕奈前1周安排多导睡眠图（PSG）记录，并在吡仑帕奈治疗12周后以及至少4周稳定使用吡仑帕奈剂量后进行对照PSG记录；患者完成爱泼沃斯思睡量表（ESS）和匹兹堡睡眠质量指数（PSQI）问卷。主要终点是ESS和PSQI评分以及PSG变量相对于基线的变化。
纳入的25例患者（年龄18 - 65岁，56%为女性）中只有17例完成了研究。吡仑帕奈使平均ESS评分（n = 13例患者；p = 0.126）和PSQI评分（n = 12例患者；p = 0.127）相对于基线有适度下降。治疗显著改善了睡眠参数（n = 17例患者），包括总睡眠时间（p = 0.037）、睡眠潜伏期（p = 0.022）、睡眠效率（p = 0.015）、睡眠维持指数（p = 0.005）、睡眠开始后的觉醒时间（p = 0.015）以及N3睡眠阶段时长（p = 0.026）。基线时睡眠效率参数改变的患者睡眠维持指数显著增加（p = 0.015），77.8%的患者睡眠效率>85%（与基线相比p = 0.016）。
吡仑帕奈改善了局灶性难治性癫痫患者的睡眠结构，且未加重日间嗜睡。
