Drachman D A, Paterson P Y, Schmidt R T, Spehlmann R F
J Neurol Neurosurg Psychiatry. 1975 Jun;38(6):592-7. doi: 10.1136/jnnp.38.6.592.
Cyclophosphamide (CY) has been shown to reverse the signs of experimental allergic encephalomyelitis (EAE) even after the onset of neurological deficits. Because of the analogy of EAE to exacerbations of multiple sclerosis (MS) a clinical trial of CY in acute MS exacerbations was undertaken. A 'sequential criterion' method was used to minimize the size of sample needed for this pilot study. CY failed to alter significantly the course of acute exacerbations of MS. Possible reasons for this failure, and the value of the sequential criterion method in pilot studies, are discussed.
环磷酰胺(CY)已被证明即使在神经功能缺损出现后也能逆转实验性变应性脑脊髓炎(EAE)的症状。由于EAE与多发性硬化症(MS)病情加重情况相似,因此开展了一项关于CY治疗急性MS病情加重的临床试验。采用“序贯标准”方法以尽量减少该初步研究所需的样本量。CY未能显著改变MS急性病情加重的病程。本文讨论了此次试验失败的可能原因以及序贯标准方法在初步研究中的价值。