Snoeijen-Schouwenaars Francesca M, van Ool Jans S, Tan In Y, Schelhaas Helenius J, Majoie Marian H J M
Academic Centre for Epileptology Kempenhaeghe, Department of Residential Care, The Netherlands.
Academic Centre for Epileptology Kempenhaeghe, Department of Residential Care, The Netherlands.
Epilepsy Behav. 2017 Jan;66:64-67. doi: 10.1016/j.yebeh.2016.10.013. Epub 2016 Dec 27.
Initial registration studies of perampanel (PMP), an AMPA receptor antagonist, have now been followed up by 'clinical' studies that confirmed its efficacy and safety in patients with refractory epilepsy. Publications on the use of PMP among patients with intellectual disability (ID) are still limited. This study extends our knowledge with respect to the relevance of PMP for patients with both ID and epilepsy, and furthermore specifies the behavioral side effects of PMP in this specific population.
Retrospective evaluation of medical records at 3, 6 and 12months of follow-up after the initial start of PMP.
62 patients were included. 21 patients (33.9%) were female. All patients had complete data of 6months follow-up and we were able to review 42 patients with a 1-year follow-up. Level of ID varied from borderline to profound, and mild ID was most common (43.5%). The mean maximum daily dosage of PMP was 5.6mg (range 1-12mg). Retention rates for PMP were 87.1% and 67.7% after three and six months. A trend indicated a longer mean retention time in patients with a more severe ID (borderline-mild-moderate ID: 205days, severe-profound ID: 275days). Seizure reduction was achieved in 53.2%. 36 patients (58.1%) experienced adverse effects, 80.6% of those within 3months. 45.2% of the patients experienced somatic adverse effects. Most common were fatigue & sleep problems, motor problems & unsteadiness, and gastrointestinal problems. Behavioral adverse effects were present in 40.3%. Most common were aggression, agitated behavior, disruptive behavior, and mood symptoms. Reasons for discontinuation of PMP were lack of efficacy in 14.8%, intolerable adverse effects in 44.4%, and a combination of both in 40.7%. Altogether, 24.2% (15/62) of the patients achieved seizure reduction without experiencing adverse effects, though none reached seizure freedom.
The use of PMP might lead to an effective seizure reduction without adverse effects in a minority of patients with both epilepsy and ID. Pre-existing behavioral problems or polypharmacy do not predict the occurrence of additional behavioral adverse effects, implying that these patients need not be excluded from the introduction of PMP when clinically indicated. Patients should, ideally, be monitored at a multidisciplinary clinic.
作为一种α-氨基-3-羟基-5-甲基-4-异恶唑丙酸（AMPA）受体拮抗剂，吡仑帕奈（PMP）的初始注册研究现已跟进了“临床”研究，这些研究证实了其在难治性癫痫患者中的疗效和安全性。关于在智力残疾（ID）患者中使用PMP的出版物仍然有限。本研究扩展了我们对于PMP在ID和癫痫患者中的相关性的认识，此外还明确了PMP在这一特定人群中的行为副作用。
对开始使用PMP后3、6和12个月随访时的病历进行回顾性评估。
纳入62例患者。21例患者（33.9%）为女性。所有患者均有6个月随访的完整数据，我们能够对42例患者进行1年随访。ID程度从临界到重度不等，轻度ID最为常见（43.5%）。PMP的平均最大日剂量为5.6mg（范围1 - 12mg）。3个月和6个月后PMP的保留率分别为87.1%和67.7%。一种趋势表明，ID更严重的患者（临界-轻度-中度ID：205天，重度-极重度ID：275天）平均保留时间更长。53.2%的患者癫痫发作减少。36例患者（58.1%）出现不良反应，其中80.6%在3个月内出现。45.2%的患者出现躯体不良反应。最常见的是疲劳和睡眠问题、运动问题和不稳以及胃肠道问题。行为不良反应发生率为40.3%。最常见的是攻击行为、激越行为、破坏行为和情绪症状。停用PMP的原因分别为疗效不佳占14.8%、无法耐受的不良反应占44.4%、两者兼而有之占40.7%。总体而言，24.2%（15/62）的患者癫痫发作减少且未出现不良反应，尽管无人达到无癫痫发作。
对于少数同时患有癫痫和ID的患者，使用PMP可能有效减少癫痫发作且无不良反应。既往存在的行为问题或联合用药并不能预测额外行为不良反应的发生，这意味着在临床指征明确时，这些患者无需被排除在引入PMP的治疗之外。理想情况下，患者应在多学科诊所接受监测。
