Shofer J B, Temkin N R
Arch Neurol. 1986 Sep;43(9):877-81. doi: 10.1001/archneur.1986.00520090017009.
Studies to determine the efficacy of antiepileptic drugs often use seizure frequency as an outcome measure. Time to kth seizure (k up to 12) was investigated as an alternative endpoint. Monte Carlo simulations, based on seizure behavior in previous clinical trials, were used to evaluate crossover studies with these endpoints. exhibited the highest power. However, tests on time to the 12th seizure, for a sample size of 50, approached the power of tests on seizure frequency with a sample size of 20. Including patients with less severe epilepsy (two vs four seizures per month) did not change the power of tests on time to the kth seizure and lowered it only moderately for tests on seizure frequency. The simulation methodology presented can be adapted to evaluate other design variations.
确定抗癫痫药物疗效的研究通常将癫痫发作频率作为一项结果指标。研究了第k次癫痫发作的时间（k最大为12）作为替代终点。基于先前临床试验中的癫痫发作行为进行的蒙特卡洛模拟，用于评估以这些终点进行的交叉研究。显示出最高的检验效能。然而，对于样本量为50的情况，第12次癫痫发作时间的检验效能接近样本量为20时癫痫发作频率检验的效能。纳入癫痫病情较轻的患者（每月发作2次与4次），对于第k次癫痫发作时间的检验效能没有改变，而对于癫痫发作频率的检验效能仅略有降低。所提出的模拟方法可用于评估其他设计变化。
