Afra Pegah, Adamolekun Bola
Department of Neurology, School of Medicine, University of Utah, Salt Lake City, UT, USA.
Department of Neurology, University of Tennessee Health Science Center, Memphis, TN, USA.
Neuropsychiatr Dis Treat. 2014 Mar 19;10:493-8. doi: 10.2147/NDT.S39152. eCollection 2014.
Zonisamide is an antiepileptic drug that is structurally different from other antiepileptic agents. Its long half-life, once-daily dosing, lack of induction of hepatic enzymes, and broad spectrum of action makes it a suitable candidate for monotherapy. It has been approved as monotherapy for partial onset epilepsy in Japan and South Korea for more than a decade, and was recently approved as monotherapy in Europe. In the USA, it is only approved by the US Food and Drug Administration for adjunctive treatment of partial onset epilepsy. In this paper, we briefly review the literature on zonisamide monotherapy in partial onset epilepsy with regard to its efficacy, safety, tolerability, and long-term side effects, including a recent noninferiority trial in comparison with extended-release carbamazepine. While European regulatory agencies use noninferiority trials for approval of monotherapy, such a trial design does not meet the current regulatory requirements for approval as monotherapy in the USA.
唑尼沙胺是一种抗癫痫药物，其结构与其他抗癫痫药物不同。它半衰期长、每日一次给药、不诱导肝酶且作用谱广，使其成为单药治疗的合适候选药物。在日本和韩国，它已被批准作为部分性发作癫痫的单药治疗药物超过十年，最近在欧洲也被批准作为单药治疗药物。在美国，它仅被美国食品药品监督管理局批准用于部分性发作癫痫的辅助治疗。在本文中，我们简要回顾了关于唑尼沙胺单药治疗部分性发作癫痫的文献，涉及其疗效、安全性、耐受性和长期副作用，包括最近一项与缓释卡马西平相比的非劣效性试验。虽然欧洲监管机构使用非劣效性试验来批准单药治疗，但这种试验设计不符合美国目前批准作为单药治疗的监管要求。
