Pérez-Miranda J, Aguirre J, Parrilla J L, Pérez Miranda M
Facultad de Medicina, Universidad de Extremadura, Badajoz.
Rev Neurol. 1995 Nov-Dec;23(124):1220-5.
The present work is a review of the new anti-epileptic drug felbamate. Felbamate is a dicarbonate with antiepileptic effects in partial attacks and in Lennox-Gastaut syndrome. This new drug is especially interesting since its pharmacological action on test animals would indicate a wider anti-epileptic spectrum of activity than most other such drugs. We review the clinical pharmacology of felbamate, its development as a new antiepileptic and the new clinical control type trials carried out into epilepsy. We also give a summary of clinical trial experiments performed using felbamate in the treatment of partial refractory attack and of Lennox-Gastaut syndrome. Felbamate has turned out to be the first anti-epileptic with specific efficacy in Lennox-Gastaut syndrome. Felbamate was approved as an anti-epileptic by the United States Food And Drug Administration in July 1993 for clinical use with children suffering from Lennox-Gastaut syndrome and with adults having partial epileptic attacks. 1994 saw some cases of aplastic anaemia and liver failure associated with treatment using felbamate which called for a reevaluation of the benefit-risk factors of the drug. Its use in the European Union was restricted to Lennox-Gastaut syndrome, and rigorous liver function and haematological controls were set up in patients so treated. In the United States the FDA also allows treatment using felbamate of partial attacks not responding to any type of medicine.
本研究是对新型抗癫痫药物非氨酯的综述。非氨酯是一种二碳酸盐,对部分发作性癫痫和伦诺克斯-加斯东综合征具有抗癫痫作用。这种新药特别引人关注,因为其对实验动物的药理作用表明,它比大多数其他此类药物具有更广泛的抗癫痫活性谱。我们综述了非氨酯的临床药理学、其作为新型抗癫痫药物的研发过程以及针对癫痫开展的新的临床对照试验类型。我们还总结了使用非氨酯治疗部分难治性发作和伦诺克斯-加斯东综合征的临床试验实验情况。事实证明,非氨酯是第一种对伦诺克斯-加斯东综合征具有特效的抗癫痫药物。1993年7月,非氨酯被美国食品药品监督管理局批准作为抗癫痫药物用于患有伦诺克斯-加斯东综合征的儿童和患有部分性癫痫发作的成人临床治疗。1994年,出现了一些与使用非氨酯治疗相关的再生障碍性贫血和肝功能衰竭病例,这就需要重新评估该药物的效益风险因素。其在欧盟的使用仅限于伦诺克斯-加斯东综合征,并且对接受该治疗的患者建立了严格的肝功能和血液学监测。在美国,食品药品监督管理局也允许使用非氨酯治疗对任何类型药物均无反应的部分性发作。