Specchio Luigi M, Boero Giovanni, Specchio Nicola, De Agazio Giusi, De Palo Alessia, de Tommaso Marina, Beghi Ettore, La Neve Angela
Department of Medical and Occupational Sciences, Section of Clinic of the Nervous System Diseases, University of Foggia, Foggia, Italy.
Seizure. 2006 Mar;15(2):112-6. doi: 10.1016/j.seizure.2005.11.006. Epub 2006 Jan 6.
The objective of this observational study was to compare the efficacy of levetiracetam and topiramate during the first 15 days of add-on treatment in adults with refractory partial epilepsy. Two cohorts of patients with > or =3 simple or complex partial seizures with or without secondary generalisation per month over an 8-week baseline period received levetiracetam or topiramate in two distinct phases, in addition to standard antiepileptic treatment. During the first 15 days of the therapy, levetiracetam was added at the dosage of 250 mg b.i.d. or topiramate at 25mg o.i.d. Efficacy parameters included number of seizure-free days (SFDs), mean and percent reduction in seizure frequency (in general and by type), and number of seizure-free patients in the first 15 days of treatment compared to last 15 days of the baseline period. Sixty-one patients received levetiracetam and 61 topiramate. The general characteristics of the two treatment groups were similar. The total number of SFDs during 15 days before treatment was 637 with levetiracetam and 621 with topiramate; in the 15-day evaluation period the SFDs increased to 748 (17.4%) and 668 (7.6%), respectively (ANOVA, p<0.05). Twenty-six patients (42.6%) taking levetiracetam were seizure free compared to 10 (16.4%) receiving topiramate (chi-square, p=0.003). This open-label non-controlled study suggests an early efficacy of levetiracetam as add-on therapy in patients with refractory partial epilepsy: these results appear to confirm previous indications of a rapid onset of action and seem to suggest first evaluation of the patient at the dose of 500 mg/day before increasing to the considered minimum standard dose of 1000 mg/day, as some patients could respond to the starting dose.
这项观察性研究的目的是比较左乙拉西坦和托吡酯在难治性部分性癫痫成人患者附加治疗的前15天中的疗效。两组患者在为期8周的基线期内每月有≥3次简单或复杂部分性发作，伴或不伴继发性全身性发作，除接受标准抗癫痫治疗外，在两个不同阶段分别接受左乙拉西坦或托吡酯治疗。在治疗的前15天，左乙拉西坦以250mg每日两次的剂量添加，或托吡酯以25mg每日三次的剂量添加。疗效参数包括无癫痫发作天数（SFDs）、癫痫发作频率的均值和降低百分比（总体及按类型），以及治疗前15天与基线期最后15天相比无癫痫发作患者的数量。61例患者接受左乙拉西坦治疗，61例接受托吡酯治疗。两个治疗组的一般特征相似。治疗前15天左乙拉西坦组的SFDs总数为637天，托吡酯组为621天；在15天评估期内，SFDs分别增至748天（增加17.4%）和668天（增加7.6%）（方差分析，p<0.05）。服用左乙拉西坦的26例患者（42.6%）无癫痫发作，而接受托吡酯治疗的患者为10例（占16.4%）（卡方检验，p=0.003）。这项开放标签的非对照研究表明，左乙拉西坦作为难治性部分性癫痫患者的附加治疗具有早期疗效：这些结果似乎证实了先前关于起效迅速的指征，并且似乎表明在增加至考虑的最低标准剂量1000mg/天之前，应首先以500mg/天的剂量对患者进行评估，因为一些患者可能对起始剂量有反应。
