Pinto A, Sander J W
Department of Clinical and Experimental Epilepsy, Institute of Neurology, University College London, London, UK.
Int J Clin Pract. 2003 Sep;57(7):616-21.
Levetiracetam (LEV) is the most recently licensed antiepileptic drug (AED) for adjunctive therapy of partial seizures. Its mechanism of action is uncertain but it exhibits a unique profile of anticonvulsant activity in models of chronic epilepsy. Three randomised, double-blind, placebo-controlled trials enrolling 904 patients with refractory partial epilepsy have demonstrated the efficacy of LEV as adjunctive therapy, with a responder rate (> or = 50% reduction in seizure frequency) of 28-41%. Long-term efficacy studies suggest retention rates of 60% after one year, with 13% of patients seizure-free for six months of the study and 8% seizure-free for one year. Adverse effects of LEV, including somnolence, lethargy and dizziness, were generally mild and the frequency of incidents was not significantly different between the active treatment and placebo groups in clinical trials. LEV has no clinically significant pharmacokinetic interactions (PKI) with other AEDs, or with commonly prescribed medications. Preliminary data suggest that LEV has efficacy in primary generalised epilepsy and further randomised trials are under way. The combination of potent antiepileptic properties with a relatively mild adverse effect profile makes LEV an attractive adjunctive therapy for partial seizures.
左乙拉西坦(LEV)是最近获批用于部分性癫痫辅助治疗的抗癫痫药物(AED)。其作用机制尚不确定,但在慢性癫痫模型中显示出独特的抗惊厥活性特征。三项纳入904例难治性部分性癫痫患者的随机、双盲、安慰剂对照试验证明了LEV作为辅助治疗的疗效,有效率(癫痫发作频率降低≥50%)为28% - 41%。长期疗效研究表明,一年后的保留率为60%,13%的患者在研究的六个月内无癫痫发作,8%的患者一年无癫痫发作。LEV的不良反应包括嗜睡、乏力和头晕,一般较为轻微,在临床试验中,活性治疗组和安慰剂组的不良事件发生率无显著差异。LEV与其他AED或常用药物之间无临床显著的药代动力学相互作用(PKI)。初步数据表明LEV对原发性全身性癫痫有效,进一步的随机试验正在进行中。强效抗癫痫特性与相对较轻的不良反应特征相结合,使LEV成为部分性癫痫有吸引力的辅助治疗药物。