Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, Università Campus Bio-Medico di Roma, Rome, Italy.
Department of Neurology and Psychiatry, Sapienza University, Policlinico Umberto I Hospital, Rome, Italy.
Seizure. 2018 May;58:35-40. doi: 10.1016/j.seizure.2018.03.028. Epub 2018 Mar 30.
Eslicarbazepine acetate (ESL) is a third-generation member of the dibenzazepine family approved in 2009 by the European Medicines Agency with the indication of adjunctive therapy in adult people with partial-onset seizures (PPOS). We aimed at assessing the ESL impact on seizure frequency and quality of life in PPOS with a particular attention to sleepiness and depression.
We evaluated 50 adult PPOS (>18 years; 48 ± 14 years-old; 23 males) treated with adjunctive ESL for ≥2months with a retrospective multi-centric design. Clinical files of the last 2 years were reviewed checking for monthly seizure frequency, treatment retention rate, adverse drug reactions (ADRs), concomitant anti-epileptic drugs and behavioural scales for sleepiness (Stanford Sleepiness Scale, SSS, and Epworth Sleepiness Scale, ESS), depression (Beck Depression Inventory-II, BDI) and overall quality of life (QOLIE-31).
At the end of 96 ± 28 days of ESL treatment, the mean seizure reduction was 56%; 60% of patients had seizure reduction above 50%, with a 31% of the whole population becoming seizure free. We reported 16 ADRs with 4 hyponatremia. Retention rate was 76%. Patient reported less sleepiness after ESL (SSS, p = 0.031; ESS, p = 0.0000002). Before ESL, 38% of patients had pathologic BDI scores, which normalized in most of them (73%) after ESL (BDI improvement, p = 0.000012). These scores resulted in an amelioration of quality of life (QOLIE-31, p = 0.000002).
ESL is a safe and effective anti-epileptic drug in a real life scenario, with an excellent behavioural profile for the overall quality of life and, in particular, for sleepiness and depression.
依佐加滨醋酸酯（ESL）是苯并二氮䓬家族的第三代成员，于 2009 年被欧洲药品管理局批准用于成人部分发作性癫痫（PPOS）的附加治疗。我们旨在评估 ESL 对 PPOS 癫痫发作频率和生活质量的影响，特别关注嗜睡和抑郁。
我们采用回顾性多中心设计，评估了 50 名接受 ESL 附加治疗≥2 个月的成年 PPOS（>18 岁；48±14 岁；23 名男性）。检查了每月癫痫发作频率、治疗保留率、药物不良反应（ADR）、同时使用的抗癫痫药物以及嗜睡（斯坦福嗜睡量表，SSS 和 Epworth 嗜睡量表，ESS）、抑郁（贝克抑郁量表-II，BDI）和整体生活质量（QOLIE-31）的行为量表。
在 ESL 治疗的 96±28 天结束时，癫痫发作的平均减少率为 56%；60%的患者癫痫发作减少超过 50%，整个人群中有 31%的患者无癫痫发作。我们报告了 16 例 ADR，其中 4 例为低钠血症。保留率为 76%。患者报告 ESL 后嗜睡减轻（SSS，p=0.031；ESS，p=0.0000002）。在 ESL 之前，38%的患者 BDI 评分异常，其中大多数患者（73%）在 ESL 后恢复正常（BDI 改善，p=0.000012）。这些评分改善了生活质量（QOLIE-31，p=0.000002）。
ESL 是一种安全有效的抗癫痫药物，在现实生活中具有良好的行为特征，对整体生活质量，特别是对嗜睡和抑郁有改善作用。
