Operto Francesca Felicia, Orsini Alessandro, Sica Gianpiero, Scuoppo Chiara, Padovano Chiara, Vivenzio Valentina, de Simone Valeria, Rinaldi Rosetta, Belfiore Gilda, Mazza Roberta, Aiello Salvatore, Vetri Luigi, Donadio Serena, Labate Angelo, Pastorino Grazia Maria Giovanna
Child and Adolescent Neuropsychiatry Unit, Department of Medicine, Surgery and Dentistry, University of Salerno, Salerno, Italy.
Pediatric Neurology, Pediatric Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
Front Neurol. 2022 Aug 11;13:952900. doi: 10.3389/fneur.2022.952900. eCollection 2022.
The aim of our study was to evaluate the effectiveness and tolerability of perampanel (PER) as first add-on and as second line monotherapy in subjects with childhood absence epilepsy.
Our sample consisted of 20 patients with childhood absence epilepsy, aged between 8 and 10, already in therapy with a first antiseizure medication with incomplete seizure control. PER was added as first add-on in a dose ranging from 3 to 8 mg/die with 1- 2 mg/week increments. The patients that were seizure-free were shifted to a PER monotherapy. All patients underwent a standardized neuropsychological evaluation in order to assess non-verbal intelligence and executive functions before adding PER and after 6 months of drug therapy. All parents completed two questionnaires, in order to assess the emotional-behavioral problems and parental stress.
15/20 patients responded to add-on PER and were seizure-free, in 3/20 patients we observed a reduction of seizure frequency <50%, and in the 2 remaining patients the add-on therapy with PER did not lead to a reduction in seizures frequency from baseline. The patients who were seizure-free were switched to PER monotherapy. 9/15 patients remained seizure-free in monotherapy with PER. In the first month of therapy with PER 2/20 patients (10%) reported mild, transient side effects of irritability, headache and dizziness, which did not lead to discontinuation of therapy. Adjunctive treatment with PER did not negatively affect non-verbal intelligence, executive functions, emotional/behavioral symptoms of children and parental stress levels.
Our clinical experience in real life showed that PER appears to be effective in the control of absence seizures in childhood absence epilepsy, with a favorable tolerability profile. PER would seem effective on absence seizures even in monotherapy. Further studies with larger samples, longer follow-up and controlled vs. placebo (or other first choice antiseizure medications) are needed to confirm our data.
我们研究的目的是评估吡仑帕奈（PER）作为儿童失神癫痫患者的一线添加治疗药物和二线单药治疗药物的有效性和耐受性。
我们的样本包括20例年龄在8至10岁之间的儿童失神癫痫患者，他们已经在接受第一种抗癫痫药物治疗，但癫痫控制不完全。PER作为一线添加治疗药物，剂量范围为3至8毫克/天，每周增加1至2毫克。癫痫发作得到控制的患者转为PER单药治疗。所有患者在添加PER之前和药物治疗6个月后均接受标准化神经心理评估，以评估非语言智力和执行功能。所有家长完成两份问卷，以评估情绪行为问题和家长压力。
20例患者中有15例对添加PER有反应且癫痫发作得到控制，20例患者中有3例癫痫发作频率降低<50%，其余2例患者添加PER治疗后癫痫发作频率未从基线水平降低。癫痫发作得到控制的患者转为PER单药治疗。15例患者中有9例在PER单药治疗中仍无癫痫发作。在使用PER治疗的第一个月，20例患者中有2例（10%）报告了轻度、短暂的易怒、头痛和头晕副作用，但未导致停药。PER辅助治疗对儿童的非语言智力、执行功能、情绪/行为症状和家长压力水平没有负面影响。
我们在现实生活中的临床经验表明，PER似乎对控制儿童失神癫痫的失神发作有效，耐受性良好。即使在单药治疗中，PER对失神发作似乎也有效。需要进一步进行更大样本、更长随访时间且与安慰剂（或其他一线抗癫痫药物）对照的研究来证实我们的数据。
