临床试验中安慰剂的使用和滥用。

Q Medicine Forschende Komplementarmedizin Pub Date : 1998-01-01 DOI:10.1159/000057332
Kleijnen
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引用次数: 5

摘要

这篇文章特别关注了当标准药物已经可用时,在新药评估中使用安慰剂的利弊。安慰剂使盲法成为可能,从而有助于在评估试验结果时控制测量偏差。在决定是否使用安慰剂时,需要考虑几个因素。有法律方面、注册要求、商业利益、医疗问题和科学方面。当患者的病情不危及生命,并且安慰剂治疗没有不可逆转的后果时,即使有标准药物可用,也可以而且应该在所有研究中使用安慰剂,但显然只有在知情同意之后。如果在评估新药与标准药物时忽略安慰剂组,则证据不足。显然,这会导致伦理方面和科学方面的冲突,但如果不使用安慰剂组,它将减缓医学的发展,减少治疗的可能性。
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The Use and Abuse of Placebo in Clinical Trials.

This article particularly looks at the advantages and disadvantages of the use of placebos in the evaluation of new drugs when a standard drug is already available. Placebos make blinding possible and in that way help to control measurement bias when assessing the outcome of a trial. Several considerations need to be made when deciding whether to use a placebo. There are legal aspects, registration requirements, commercial interests, medical issues and scientific aspects. A placebo can and should be used in all research when the condition of the patient is not life-threatening and when there are no irreversible consequences of placebo treatment, even if a standard drug is available, but obviously only after informed consent. Insufficient evidence is provided if a placebo group is omitted when assessing a new drug versus standard drug. Obviously, this causes a conflict between the ethical aspects on one hand and the scientific aspects on the other, but if placebo groups are not used it will slow developments in medicine and reduce therapeutic possibilities.

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