Guy W, McEvoy J M, Ban T A, Wilson W H, Pate K
Pharmacotherapy. 1983 Jan-Feb;3(1):45-51. doi: 10.1002/j.1875-9114.1983.tb04532.x.
A 6-week double-blind comparison of mianserin, a new antidepressant, and amitriptyline allowed us to explore the problem of demonstrating main effect differences in drug/drug trials when the focus is primarily only upon efficacy or upon common adverse symptomatology. Statistical analyses of standard psychiatric rating scales revealed no significant treatment differences, while both treatment groups exhibited significant parallel improvement across time. Examination of treatment emergent symptoms indicated that, while it evoked fewer anticholinergic symptoms than amitriptyline, mianserin exhibited a different profile of adverse symptomatology. The usefulness of a measure of the benefit/risk ratio was described as a means of clarifying drug/drug comparisons.
一项为期6周的新型抗抑郁药米安色林与阿米替林的双盲对照试验，使我们能够探讨在药物/药物试验中，当主要关注疗效或常见不良反应症状时，如何证明主要效应差异的问题。对标准精神科评定量表的统计分析显示，治疗组之间无显著差异，而两个治疗组均随时间呈现出显著的平行改善。对治疗中出现的症状的检查表明，虽然米安色林引起的抗胆碱能症状比阿米替林少，但它表现出不同的不良反应症状特征。有人描述了一种衡量效益/风险比的方法，作为澄清药物/药物比较的一种手段。
