Neuroimaging Department, University Hospital Roger Salengro, Lille.
Neurology Department, University Hospital, Nice.
Epileptic Disord. 2014 Jun;16(2):165-74. doi: 10.1684/epd.2014.0650.
The aim of this study was to evaluate the impact of two different therapeutic strategies in patients with partial seizures who were intractable to the first prescribed antiepileptic drug (AED); alternative monotherapy vs early add-on treatment.
We conducted an open, cluster-randomised, prospective, controlled trial in patients with persistent partial seizures, despite treatment with one AED, who were never administered any other AEDs. Neurologists were randomised to two strategies: in group A, an alternative monotherapy with a second AED was employed; in group B, add-on treatment with a second AED was employed. The primary outcome was the percentage of seizure-free patients during a two-month period after six months of treatment. The secondary outcomes were: (i) the percentage of patients achieving a 50% reduction in the number of seizures at six months; (ii) the quality of life based on the Quality Of Life In Epilepsy scale; and (iii) tolerability.
A total of 143 neurologists were included and randomised, and 264 patients were evaluated. At six months, the primary outcome was 51% in group A and 45% in group B (p=0.34). The percentage of patients achieving a 50% reduction in the number of seizures at six months was 76% in group A and 84% in group B (p=0.53). The quality of life and the tolerability did not significantly differ between the two groups.
Alternative monotherapy or early treatment initiation with another AED drug resulted in similar efficacy, and the side effects associated with monotherapy and combined therapies were similar, which suggests that individual susceptibility is more important than the number and burden of AEDs used.
本研究旨在评估两种不同治疗策略对首种抗癫痫药物（AED）治疗无效的部分性发作患者的影响；替代单药治疗与早期加用治疗。
我们进行了一项开放、集群随机、前瞻性、对照试验，纳入持续存在部分性发作且使用一种 AED 治疗但从未使用过其他 AED 的患者。神经科医生被随机分为两组：在 A 组中，采用第二种 AED 进行替代单药治疗；在 B 组中，采用第二种 AED 进行加用治疗。主要结局为治疗 6 个月后 2 个月内无发作患者的百分比。次要结局为：（i）6 个月时发作次数减少 50%的患者比例；（ii）基于癫痫生活质量量表的生活质量；以及（iii）耐受性。
共有 143 名神经科医生被纳入并随机分组，264 名患者接受了评估。6 个月时，A 组的主要结局为 51%，B 组为 45%（p=0.34）。6 个月时发作次数减少 50%的患者比例在 A 组为 76%，B 组为 84%（p=0.53）。两组间生活质量和耐受性无显著差异。
替代单药治疗或早期加用另一种 AED 药物的疗效相似，且单药治疗和联合治疗相关的副作用相似，这表明个体易感性比使用的 AED 数量和负担更重要。
