Wilder B J
University of Florida College of Medicine, Gainesville 32608-1197.
Can J Neurol Sci. 1994 Aug;21(3):S17-20. doi: 10.1017/s0317167100040774.
No new antiepileptic drugs (AEDs) were licensed in the United States from 1978 to 1992. In late 1992, felbamate and gabapentin were recommended for approval, and in early 1993, lamotrigine. In July 1993, felbamate was licensed, and gabapentin and lamotrigine may soon follow. Lamotrigine, vigabatrin and clobazam are in use outside the US. Tiagabine, oxcarbazepine, fosphenytoin, topiramate, vigabatrin and zonisamide are in Phase II clinical testing in the US. All of the new AEDs are effective against partial and tonic-clonic seizures. Few controlled clinical trials have been done in patients with absence and myoclonic seizures. Mechanisms of action of the new drugs have not been clearly defined. The new AEDs will provide an opportunity to improve the care of epileptic patients. Even with optimal management with currently available drugs, some 30% of patients remain refractory to medical management.
1978年至1992年期间,美国没有新的抗癫痫药物(AEDs)获批上市。1992年末,非氨酯和加巴喷丁被推荐批准上市,1993年初,拉莫三嗪也被推荐批准上市。1993年7月,非氨酯获批上市,加巴喷丁和拉莫三嗪可能也将很快获批。拉莫三嗪、氨己烯酸和氯巴占在美国以外地区已投入使用。替加宾、奥卡西平、磷苯妥英、托吡酯、氨己烯酸和唑尼沙胺在美国正处于二期临床试验阶段。所有这些新型抗癫痫药物对部分性发作和强直阵挛性发作均有效。针对失神发作和肌阵挛发作患者开展的对照临床试验较少。这些新药的作用机制尚未明确界定。新型抗癫痫药物将为改善癫痫患者的治疗提供契机。即便使用现有药物进行最佳管理,仍有约30%的患者药物治疗效果不佳。