Toledo Manuel, Gonzalez-Cuevas Montserrat, Miró-Lladó Julia, Molins-Albanell Albert, Falip Mercé, Martinez Ana Belén, Fernandez Santiago, Quintana Manuel, Cambrodi Roser, Santamarina Estevo, Salas-Puig Javier
Epilepsy Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain.
Epilepsy Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain.
Epilepsy Behav. 2016 Oct;63:57-62. doi: 10.1016/j.yebeh.2016.08.004. Epub 2016 Aug 24.
The purpose of this study was to evaluate subjective sleep quality and daytime sleepiness in patients receiving adjunctive perampanel for focal seizures.
We conducted a multicenter, prospective, interventional, open-label study in patients aged >16 with focal seizures who received adjunctive perampanel (flexible dosing: 2-12mg). Sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI) and daytime sleepiness with the Epworth Sleepiness Scale (ESS) at baseline and 3 and 6months after initiating perampanel. Patients with modifications in their baseline AEDs or sleep medications were excluded.
In 72 patients with drug-resistant focal seizures, mean baseline PSQI score (±standard deviation) was 7.26 (±4.6), and ESS was 6.19 (±4.2). At 3months (median perampanel dose: 4mg), there was no significant mean change from baseline in ESS score (n=61) and a significant improvement in PSQI (-1.51 points; n=44; p=0.007), driven mainly by improved sleep efficiency (p=0.012). In the 31 patients with 6-month data, ESS (but not PSQI) improved significantly at 6months vs baseline (p=0.029). The only factor significantly correlated with sleep parameters was number of baseline AEDs (higher number correlated with worse daytime sleepiness). Seizure frequency was reduced significantly from baseline at 3 and 6months. In bivariate analysis, neither PSQI nor ESS was associated with seizure frequency, suggesting that the changes in daytime sleepiness and sleep quality may be independent of the direct effect on seizures.
Adjunctive perampanel did not worsen sleep quality or daytime sleepiness at 3months and reduced daytime sleepiness in patients continuing perampanel for 6months. Perampanel may be a suitable AED in patients with sleep disorders, in addition to refractory focal seizures.
本研究旨在评估接受吡仑帕奈辅助治疗局灶性癫痫患者的主观睡眠质量和日间嗜睡情况。
我们对年龄大于16岁的局灶性癫痫患者进行了一项多中心、前瞻性、干预性、开放标签研究,这些患者接受吡仑帕奈辅助治疗(灵活给药:2 - 12毫克)。在基线时以及开始使用吡仑帕奈后的3个月和6个月,使用匹兹堡睡眠质量指数(PSQI)评估睡眠质量,使用爱泼华嗜睡量表(ESS)评估日间嗜睡情况。排除基线抗癫痫药物(AED)或睡眠药物有调整的患者。
在72例耐药性局灶性癫痫患者中,平均基线PSQI评分(±标准差)为7.26(±4.6),ESS评分为6.19(±4.2)。在3个月时(吡仑帕奈中位剂量:4毫克),ESS评分(n = 61)与基线相比无显著平均变化,而PSQI有显著改善(-1.51分;n = 44;p = 0.007),主要由睡眠效率提高所致(p = 0.012)。在有6个月数据的31例患者中,与基线相比,6个月时ESS(而非PSQI)有显著改善(p = 0.029)。与睡眠参数显著相关的唯一因素是基线AED的数量(数量越多,日间嗜睡越严重)。癫痫发作频率在3个月和6个月时较基线显著降低。在双变量分析中,PSQI和ESS均与癫痫发作频率无关,这表明日间嗜睡和睡眠质量的变化可能独立于对癫痫发作的直接影响。
辅助使用吡仑帕奈在3个月时未恶化睡眠质量或日间嗜睡情况,且在持续使用吡仑帕奈6个月的患者中可减轻日间嗜睡。除难治性局灶性癫痫外,吡仑帕奈可能是睡眠障碍患者合适的抗癫痫药物。