Bourgeois B, Leppik I E, Sackellares J C, Laxer K, Lesser R, Messenheimer J A, Kramer L D, Kamin M, Rosenberg A
Cleveland Clinic Foundation, OH 44195-5221.
Neurology. 1993 Apr;43(4):693-6. doi: 10.1212/wnl.43.4.693.
We studied the efficacy and safety of felbamate, an investigational antiepileptic drug, in a unique, double-blind, placebo-controlled trial. Sixty-four patients with refractory partial-onset seizures who completed a routine evaluation for epilepsy surgery met seizure frequency entry criteria. Each patient received felbamate or placebo in addition to the anticonvulsant regimen present at the conclusion of the presurgical evaluation. The treatment phase consisted of an 8-day inpatient period and a 21-day outpatient period. The efficacy variable was time to fourth seizure. The difference in time to fourth seizure was statistically significant (p = 0.028) in favor of felbamate. Eighty-eight percent of the patients in the placebo group had a fourth seizure during the treatment phase compared with 46% of the patients in the felbamate group (p = 0.001). Adverse experiences with felbamate were generally mild or moderate in severity. This trial demonstrated the ability of felbamate to quickly and safely reduce the occurrence of frequent partial-onset seizures and maintain effective seizure control following reductions in the dosages of standard antiepileptic drugs.
我们在一项独特的双盲、安慰剂对照试验中研究了一种实验性抗癫痫药物非氨酯的疗效和安全性。64名完成癫痫手术常规评估的难治性部分性发作患者符合发作频率纳入标准。每位患者在术前评估结束时现有的抗惊厥治疗方案基础上，加用非氨酯或安慰剂。治疗阶段包括8天的住院期和21天的门诊期。疗效变量为至第四次发作的时间。至第四次发作的时间差异具有统计学意义（p = 0.028），非氨酯组更具优势。安慰剂组88%的患者在治疗阶段出现第四次发作，而非氨酯组为46%（p = 0.001）。非氨酯的不良事件一般严重程度为轻度或中度。该试验证明了非氨酯能够快速、安全地减少频繁部分性发作的发生，并在标准抗癫痫药物剂量减少后维持有效的癫痫控制。
