De Liso P, Vigevano F, Specchio N, De Palma L, Bonanni P, Osanni E, Coppola G, Parisi P, Grosso S, Verrotti A, Spalice A, Nicita F, Zamponi N, Siliquini S, Giordano L, Martelli P, Guerrini R, Rosati A, Ilvento L, Belcastro V, Striano P, Vari M S, Capovilla G, Beccaria F, Bruni O, Luchetti A, Gobbi G, Russo A, Pruna D, Tozzi A E, Cusmai R
Department of Neurosciences, Neurology Unit, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy; Department of Paediatrics, Child Neurology and Psychiatry, Sapienza University of Rome, Rome, Italy.
Department of Neurosciences, Neurology Unit, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
Epilepsy Res. 2016 Nov;127:93-100. doi: 10.1016/j.eplepsyres.2016.08.021. Epub 2016 Aug 18.
To evaluate the efficacy and tolerability of Perampanel (PER) in children and adolescents with refractory epilepsies in daily clinical practice conditions.
This Italian multicenter retrospective observational study was performed in 16 paediatric epilepsy centres. Inclusion criteria were: (i) ≤18 years of age, (ii) history of refractory epilepsy, (iii) a follow-up ≥5 months of PER add-on therapy. Exclusion criteria were: (i) a diagnosis of primary idiopathic generalized epilepsy, (ii) variation of concomitant AEDs during the previous 4 weeks. Response was defined as a ≥50% reduction in monthly seizure frequency compared with the baseline.
62 patients suffering from various refractory epilepsies were included in this study: 53% were males, the mean age was 14.2 years (range 6-18 years), 8 patients aged <12 years. Mean age at epilepsy onset was 3.4 years and the mean duration of epilepsy was 10.8 years (range 1-16), which ranged from 2 seizures per-month up to several seizures per-day (mean number=96.5). Symptomatic focal epilepsy was reported in 62.9% of cases. Mean number of AEDs used in the past was 7.1; mean number of concomitant AEDs was 2.48, with carbamazepine used in 43.5% of patients. Mean PER daily dose was 7.1mg (2-12mg). After an average of 6.6 months of follow-up (5-13 months), the retention rate was 77.4% (48/62). The response rate was 50%; 16% of patients achieved ≥75% seizure frequency reduction and 5% became completely seizure free. Seizure aggravation was observed in 9.7% of patients. Adverse events were reported in 19 patients (30.6%) and led to PER discontinuation in 4 patients (6.5%). The most common adverse events were behaviour disturbance (irritability and aggressiveness), dizziness, sedation and fatigue.
PER was found to be a safe and effective treatment when used as adjunctive therapy in paediatric patients with uncontrolled epilepsy.
在日常临床实践条件下，评估吡仑帕奈（PER）治疗儿童和青少年难治性癫痫的疗效和耐受性。
这项意大利多中心回顾性观察研究在16个儿科癫痫中心开展。纳入标准为：（i）年龄≤18岁；（ii）难治性癫痫病史；（iii）PER添加治疗随访≥5个月。排除标准为：（i）原发性特发性全身性癫痫诊断；（ii）前4周内联用抗癫痫药物（AEDs）有变化。反应定义为与基线相比每月癫痫发作频率降低≥50%。
本研究纳入62例患有各种难治性癫痫的患者：53%为男性，平均年龄14.2岁（范围6 - 18岁），8例年龄<12岁。癫痫发作的平均年龄为3.4岁，癫痫平均病程为10.8年（范围1 - 16年），每月发作2次至每天发作数次（平均次数 = 96.5次）。62.9%的病例报告为症状性局灶性癫痫。过去使用AEDs的平均数量为7.1种；联用AEDs的平均数量为2.48种，43.5%的患者使用卡马西平。PER的平均日剂量为7.1mg（2 - 12mg）。平均随访6.6个月（5 - 13个月）后，保留率为77.4%（48/62）。缓解率为50%；16%的患者癫痫发作频率降低≥75%，5%的患者癫痫完全缓解。9.7%的患者观察到癫痫发作加重。19例患者（30.6%）报告了不良事件，4例患者（6.5%）因不良事件停用PER。最常见的不良事件是行为障碍（易怒和攻击性）、头晕、镇静和疲劳。
在儿童难治性癫痫患者中，PER作为辅助治疗被发现是一种安全有效的治疗方法。
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