非氨酯：一种用于治疗癫痫的新化合物的成功研发。

Felbamate: successful development of a new compound for the treatment of epilepsy.

作者信息

Schmidt D

机构信息

Epilepsy Research Group, Free University of Berlin, Germany.

出版信息

Epilepsia. 1993;34 Suppl 7:S30-3. doi: 10.1111/j.1528-1157.1993.tb04592.x.

DOI:10.1111/j.1528-1157.1993.tb04592.x

PMID:8243376

Abstract

Felbamate (FBM) is an effective and safe novel antiepileptic drug (AED) for add-on treatment in adults with refractory partial seizures as shown in three pivotal controlled trials. In addition, FBM is effective and safe in monotherapy in adults with refractory partial seizures. FBM is also effective and safe as add-on therapy for children and adults with refractory Lennox-Gastaut syndrome. The effective daily dosage is approximately 30-45 mg/kg divided into three or four doses with resulting plasma concentrations of 50-80 mg/L. The safety profile of FBM is limited to mild gastrointestinal complaints, insomnia, and nonspecific CNS symptoms. Six pivotal controlled trials, with both classic and innovative design, showed that FBM is a useful AED.

摘要

非氨酯（FBM）是一种有效且安全的新型抗癫痫药物（AED），三项关键对照试验表明，它可用于难治性部分性癫痫发作成人患者的添加治疗。此外，非氨酯对于难治性部分性癫痫发作的成人患者单药治疗有效且安全。非氨酯作为难治性Lennox-Gastaut综合征儿童和成人患者的添加治疗同样有效且安全。有效日剂量约为30-45mg/kg，分三或四次服用，血浆浓度可达50-80mg/L。非氨酯的安全性问题仅限于轻度胃肠道不适、失眠和非特异性中枢神经系统症状。六项采用经典和创新设计的关键对照试验表明，非氨酯是一种有用的抗癫痫药物。