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[精神药物试验的规划。统计评估。假设与方法]

[Planning of psychotropic drug trials. Statistical evaluation. Hypotheses and methods].

作者信息

Immich H

出版信息

Pharmakopsychiatr Neuropsychopharmakol. 1977 May;10(3):185-92. doi: 10.1055/s-0028-1094539.

Abstract

Any reasonable evaluation presupposes a precise question. Furthermore it is necessary to eliminate all factors of disturbance, which are able either to simulate or to mask a result of evaluation. The most important of these factors is the psychiatrist himself. Therefore, experimental designs have to taken in account the factor psychiatrist. Criteria of the effects of any drug must be relevant with regard to comparison of two or more drug effects. The reproduciability of criteria is very desirable, but a wish-fulfilment under the most circumstances. Because criteria should be independent and mutually exclusive, all scales like the Hamiltons one are not suitable for evaluation. Finally one should use as few criteria as possible. Models of evaluation are described for the most frequent questions in connection with clinical trials in psychopharmacology.

摘要

任何合理的评估都预先假定有一个精确的问题。此外,有必要消除所有干扰因素,这些因素要么能够模拟要么掩盖评估结果。其中最重要的因素就是精神科医生本人。因此,实验设计必须考虑到精神科医生这一因素。任何药物效果的标准必须与两种或更多药物效果的比较相关。标准的可重复性是非常可取的,但在大多数情况下只是一种愿望。由于标准应该是独立且相互排斥的,所有像汉密尔顿量表这样的量表都不适合用于评估。最后,应该尽可能少地使用标准。针对精神药理学临床试验中最常见的问题描述了评估模型。

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