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评估精神药物的双盲设计有多可靠?

How sound is the double-blind design for evaluating psychotropic drugs?

作者信息

Fisher S, Greenberg R P

机构信息

Department of Psychiatry, State University of New York Health Science Center, Syracuse 13210.

出版信息

J Nerv Ment Dis. 1993 Jun;181(6):345-50. doi: 10.1097/00005053-199306000-00002.

Abstract

Sufficient data have accumulated to raise serious doubts about the integrity of the double-blind design that is presumed to shield psychotropic drug trials from bias and expectations. A major deficit in most drug trials has been the use of inert rather than active placebos. The deficiencies of the double-blind paradigm call for a questioning stance with respect to previous studies of psychotropic drug efficacy. Various possible ways of strengthening the double-blind paradigm are reviewed.

摘要

已有足够的数据积累,令人对双盲设计的完整性产生严重怀疑,双盲设计本应使精神药物试验免受偏差和预期的影响。大多数药物试验的一个主要缺陷是使用了无活性而非有活性的安慰剂。双盲范式的缺陷要求对先前关于精神药物疗效的研究采取质疑的态度。本文回顾了加强双盲范式的各种可能方法。

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