Oles K S, Penry J K, Smith L D, Anderson R L, Dean J C, Riela A R
Department of Neurology, Bowman Gray School of Medicine, Wake Forest University, Winston-Salem, NC 27157.
Neurology. 1992 Jun;42(6):1147-53. doi: 10.1212/wnl.42.6.1147.
We performed a randomized double-blind crossover therapeutic bioequivalency study of a generic (Epitol) versus a brand name (Tegretol) carbamazepine product under steady-state conditions in 40 epileptic patients. Each patient received 90-day supplies of Epitol or Tegretol and placebo, which replaced the usual dosage of the alternate product. Group A consisted of 20 seizure-free (from 5 months to 2 years) patients and group B of 20 patients with seizures refractory to drug therapy. In group A, four patients had seizures, two on both Epitol and Tegretol and two on Tegretol. In group B, the average seizure frequencies were 0.25 seizures per day on Epitol and 0.22 seizures per day on Tegretol. Average seizure frequencies were statistically the same (at a 20% difference, p less than 0.05). Areas under the curve were statistically the same (at a 20% difference, p = 0.05). Average peak heights were statistically the same (at a 20% difference, p less than 0.05). Average time to peak was earlier with Epitol. Epitol and Tegretol performed equally well in clinical efficacy and bioequivalency.
我们对40名癫痫患者在稳态条件下进行了一项随机双盲交叉治疗生物等效性研究，比较一种通用型（Epitol）与一种品牌型（Tegretol）卡马西平产品。每位患者接受90天用量的Epitol或Tegretol以及安慰剂，安慰剂替代了另一种产品的常规剂量。A组由20名无癫痫发作（发作间隔5个月至2年）的患者组成，B组由20名药物治疗难治性癫痫患者组成。在A组中，4名患者出现癫痫发作，2名在服用Epitol和Tegretol时均发作，2名仅在服用Tegretol时发作。在B组中，服用Epitol时平均癫痫发作频率为每天0.25次，服用Tegretol时为每天0.22次。平均癫痫发作频率在统计学上相同（差异20%，p小于0.05）。曲线下面积在统计学上相同（差异20%，p = 0.05）。平均峰值高度在统计学上相同（差异20%，p小于0.05）。Epitol达到峰值的平均时间更早。Epitol和Tegretol在临床疗效和生物等效性方面表现相当。
