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双盲试验究竟有多“盲”?对照研究的有效性

[How blind is a double-blind trial really? Validity of controlled investigations].

作者信息

Modestin J, Hodel J

出版信息

Int Pharmacopsychiatry. 1977;12(3):129-36.

PMID:334685
Abstract

During a double blind trial lasting 4 weeks (Diazepam versus Loxapin), two investigators tried to identify the given drug prematurely. Only the more experienced investigator was able to identify the two drugs (p = 0.01). His judgement was based neither on observation of side-effects nor on a clinical improvement but apparently on a summary of particular subtle effects, the cognition of which requires a specific experience. The use of an adequate comparative drug instead of a placebo in a double blind study does not completely prevent a premature decoding but should reduce this risk and therefore increase the validity of the method.

摘要

在一项为期4周的双盲试验(地西泮与洛沙平对比)中,两名研究人员试图过早识别出所给药物。只有经验更丰富的研究人员能够识别出这两种药物(p = 0.01)。他的判断既不是基于副作用的观察,也不是基于临床改善情况,而是显然基于对特定细微效应的总结,而对这些效应的认知需要特定经验。在双盲研究中使用适当的对照药物而非安慰剂并不能完全防止过早解码,但应该会降低这种风险,从而提高该方法的有效性。

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