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[关于随机对照临床试验的伦理问题]

[Ethical questions on randomized controlled clinical trials].

作者信息

Kovács J

出版信息

Orv Hetil. 1989 Apr 30;130(18):923-7.

PMID:2726243
Abstract

RCT, the new paradigm of modern medicine, was developed in the 40-s of this century and is considered to be the most up-to-date experimental method of our time in comparing the efficacy and value of various prophylactic and therapeutic strategies. Its use, however, poses several ethical questions. The most important of them are: Is this form of experimentation ethical at all? Is it ethically justified to continue the RCT to the stage to reach the statistically significant result between the groups? Is it ethical to assign the patients randomly to the various therapeutic strategies? What is the necessary amount and type of information which is due to the patient? The article endeavours to help to answer these questions.

摘要

随机对照试验是现代医学的新范式,于本世纪40年代发展起来,被认为是我们这个时代在比较各种预防和治疗策略的疗效和价值方面最先进的实验方法。然而,它的使用引发了几个伦理问题。其中最重要的问题是:这种实验形式是否完全符合伦理?将随机对照试验持续到能够得出组间具有统计学显著差异结果的阶段在伦理上是否合理?将患者随机分配到各种治疗策略中是否符合伦理?患者应得到的必要信息数量和类型是什么?本文旨在帮助回答这些问题。

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