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[新药临床试验中安慰剂使用的当代概念]

[Contemporary concept of placebo usage in clinical trials of new drugs].

作者信息

Orzechowska-Juzwenko Krystyna

机构信息

Akademia Medyczna we Wrocławiu, Katedra i Zakład Farmakologii Klinicznej.

出版信息

Pol Merkur Lekarski. 2007 Dec;23(138):473-7.

Abstract

The placebo-controlled trials have been almost always controversial since the beginning of introduction of this method into new pharmacotherapy investigations. From the legal and ethical point of view the usage of placebo is more and more frequently criticized because it devoids the patients of standard therapy advantages. Therefore, contemporary tendency to solve of ethical placebo problem connected with clinical trials of new drugs is often--application of more safe methods of results objectifying in new therapy by comparison of the results of clinical trials in the group taking a new drug to be tested to the one treated by conventional, standard, established the best so far known, pharmacotherapy.

摘要

自从将安慰剂对照试验方法引入新的药物治疗研究以来,这类试验几乎一直存在争议。从法律和伦理角度来看,安慰剂的使用越来越受到批评,因为它使患者无法获得标准治疗的益处。因此,当代解决与新药临床试验相关的伦理安慰剂问题的趋势通常是——通过将接受待测试新药治疗的组与接受传统、标准、迄今已知最佳的药物治疗的组的临床试验结果进行比较,采用更安全的方法来客观化新疗法的结果。

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