Rogers S C, Clay P M
Br J Psychiatry. 1975 Dec;127:599-603. doi: 10.1192/bjp.127.6.599.
A method of reviewing a series of clinical trials by extracting the basic data in the form of 2 x 2 tables and analysing these by Fisher's two-tailed Exact Test is described, and illustrated by published imipramine-placebo trials. The results suggest that the benefit of this drug in patients with endogenous depression who have not become institutionalized is indisputable, and that further drug-placebo trials in this condition are not justified. Two of the three trials of imipramine in neurotic depression gave results showing significant improvement. Possible explanations of the apparent failure of this drug in groups of patients with undifferentiated depression are discussed.
本文描述了一种通过以2×2表格形式提取基本数据并采用费舍尔双侧精确检验进行分析的方法来回顾一系列临床试验,并以已发表的丙咪嗪-安慰剂试验为例进行说明。结果表明,这种药物对尚未住院的内源性抑郁症患者的益处是无可争议的,在这种情况下进一步进行药物-安慰剂试验是不合理的。丙咪嗪治疗神经症性抑郁症的三项试验中有两项结果显示有显著改善。文中还讨论了该药物在未分化型抑郁症患者组中明显无效的可能原因。