Department of Pediatrics, Children's Hospital of Soochow University & Affiliated Hospital of Nantong University, No. 92 Zhongnan Street, Suzhou Industrial Park, 215025, Jiangsu, China.
Department of Pediatrics, Affiliated Hospital of Nantong University, No.20 Xi Si Road, Nantong, 226001, Jiangsu, China.
Acta Neurol Belg. 2021 Oct;121(5):1265-1273. doi: 10.1007/s13760-021-01613-5. Epub 2021 Feb 15.
Levetiracetam (LEV) and oxcarbazepine (OXC) are commonly used in the treatment of epilepsy, but their efficacy and safety have seldom been compared for the treatment of children with benign epilepsy with centrotemporal spikes (BECTS). We thus assessed the efficacy of LEV and OXC monotherapy in the treatment of children with BECTS, and the effect of this treatment on children's intelligence and cognitive development. This was a randomized, single-center trial. Children with BECTS were randomized (1:1) into LEV and OXC groups, and were assessed at 1, 3 and 6 months after treatment. The primary outcomes were the frequency of seizures and changes in intelligence and cognitive function. Secondary outcomes were electroencephalogram (EEG) results and safety. Seventy children were enrolled and randomized to the LEV group or the OXC group, and 32 of the 35 children in each group completed the study. After 6 months, the effective treatment rate of the OXC group was significantly higher than that of the LEV group (78.12 vs. 53.12%, p = 0.035). However, no significant inter-group difference was observed in EEG improvement (p = 0.211). In terms of intelligence and cognitive development, children in the OXC group exhibited significantly improved choice reaction time, mental rotation, and Wisconsin Card Sorting Test results (all p < 0.05). Both LEV and OXC were well tolerated, with 18.75 and 21.88% of children reporting mild adverse events (p = 0.756). OXC monotherapy was more effective than LEV for children with BECTS. In addition, children with OXC monotherapy had higher improvements in children's intelligence and cognitive function than those with LEV monotherapy.
左乙拉西坦（LEV）和奥卡西平（OXC）常用于治疗癫痫，但它们在治疗儿童良性癫痫伴中央颞区棘波（BECTS）中的疗效和安全性很少被比较。因此，我们评估了 LEV 和 OXC 单药治疗 BECTS 儿童的疗效，以及这种治疗对儿童智力和认知发展的影响。这是一项随机、单中心试验。BECTS 患儿按 1:1 随机分为 LEV 和 OXC 组，治疗后 1、3 和 6 个月进行评估。主要结局是发作频率以及智力和认知功能的变化。次要结局是脑电图（EEG）结果和安全性。70 名患儿入组并随机分为 LEV 组或 OXC 组，每组 35 名患儿中有 32 名完成了研究。治疗 6 个月后，OXC 组的有效治疗率明显高于 LEV 组（78.12%比 53.12%，p=0.035）。然而，两组之间在 EEG 改善方面无显著差异（p=0.211）。在智力和认知发展方面，OXC 组的儿童选择反应时间、心理旋转和威斯康星卡片分类测试结果均显著改善（均 p<0.05）。LEV 和 OXC 均耐受良好，分别有 18.75%和 21.88%的患儿报告轻度不良事件（p=0.756）。OXC 单药治疗对 BECTS 患儿更有效。此外，与 LEV 单药治疗相比，OXC 单药治疗的患儿智力和认知功能改善更高。
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