Department of Pediatric Neurology, Ankara University Faculty of Medicine, Ankara, Turkey.
Department of Pediatric Neurology, Ankara University Faculty of Medicine, Ankara, Turkey.
Epilepsy Behav. 2021 Mar;116:107745. doi: 10.1016/j.yebeh.2020.107745. Epub 2021 Jan 25.
Levetiracetam (LEV) is a second-generation antiepileptic drug with high efficacy and tolerability in children and adults with epilepsy. We aimed to retrospectively assess the long-term efficacy, tolerability, and safety of LEV monotherapy in children with epilepsy.
All patients who received LEV monotherapy at the Ankara University Children Hospital between January 2010 and June 2020 were evaluated. This retrospective pediatric cohort study determined the efficacy and safety of LEV monotherapy in 281 outpatients with epilepsy.
There were 281 patients, 50.5% female, aged 5 months to 18 years with a mean age of 9 years. Of these, 48% of patients had idiopathic epilepsy, 40.6% had symptomatic epilepsy, and 11,4% had cryptogenic/genetic epilepsy. Primary generalized seizures occurred in 61.6% of patients, focal seizures in 19.6%, both generalized and focal seizures in 15,3%, focal to bilateral tonic-clonic seizures in 2.5%, and undefined type of seizure in 1.1%. A total of 22.8% patients had an accompanying extra neurological disease, mostly cardiological and hematological. The range of final daily dose was 10-71 mg/kg/day, with mean 29.5 mg/kg/day. Duration of therapy ranged from 7 days to 96 months, with median 12 months (IQR: 6-22). For the all cohort, a 6th month retention rate was 81%, a 12th month retention rate was 71.4%, and a 24th month retention rate was 61.8%. Eighty five percent of the patients had a seizure reduction of at least 50% and 55.9% of patients remained seizure-free for median 12 months treatment duration with LEV monotherapy. Improvement of electroencephalography (EEG) findings was found in 42% of patients on control EEGs. A total of 67 adverse events were documented in 45 (16%) patients. The most common adverse events were behavioral problems such as aggression (n:18) and irritability (n:17). The discontinuation rate due to adverse events was 2.5%, and due to inefficacy was 5.3%.
The present study suggests that the high retention rates, high percentage of seizure reduction, the low discontinuation rate due to adverse events and inefficacy, and the relatively benign and transient profile of adverse events make LEV preferable as monotherapy in the pediatric population.
左乙拉西坦（LEV）是一种第二代抗癫痫药物，在儿童和成人癫痫患者中具有高效性和良好耐受性。我们旨在回顾性评估 LEV 单药治疗儿童癫痫的长期疗效、耐受性和安全性。
评估了 2010 年 1 月至 2020 年 6 月期间在安卡拉大学儿童医院接受 LEV 单药治疗的所有患者。这项回顾性儿科队列研究确定了 281 名门诊癫痫患者接受 LEV 单药治疗的疗效和安全性。
共有 281 名患者，50.5%为女性，年龄 5 个月至 18 岁，平均年龄 9 岁。其中，48%的患者为特发性癫痫，40.6%为症状性癫痫，11.4%为隐源性/遗传性癫痫。主要全身性发作占 61.6%，局灶性发作占 19.6%，全身性和局灶性发作均占 15.3%，局灶性双侧强直-阵挛性发作占 2.5%，未明类型发作占 1.1%。共有 22.8%的患者伴有其他神经系统疾病，主要为心脏和血液系统疾病。最终日剂量范围为 10-71mg/kg/天，平均 29.5mg/kg/天。治疗时间从 7 天至 96 个月不等，中位数为 12 个月（IQR：6-22）。对于所有队列，第 6 个月的保留率为 81%，第 12 个月的保留率为 71.4%，第 24 个月的保留率为 61.8%。85%的患者癫痫发作减少至少 50%，55.9%的患者在 LEV 单药治疗中位 12 个月时无癫痫发作。控制脑电图（EEG）发现 42%的患者脑电图改善。共有 45 名（16%）患者出现 67 例不良事件。最常见的不良事件是行为问题，如攻击行为（n=18）和易怒（n=17）。因不良事件导致的停药率为 2.5%，因无效导致的停药率为 5.3%。
本研究表明，高保留率、高癫痫发作减少率、因不良事件和无效而停药率低，以及不良事件相对良性和短暂的特征，使得 LEV 作为儿科人群的单药治疗更具优势。
