Placebo in Surgical Research: A Case-Based Ethical Analysis and Practical Consequences.
Placebo in Surgical Research: A Case-Based Ethical Analysis and Practical Consequences.
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DOI：
10.1155/2016/2627181
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发表时间：
2016
影响因子：
--
通讯作者：
Negoi I
中科院分区：
文献类型：
--
作者：
Hostiuc S;Rentea I;Drima E;Negoi I
安慰剂是一种模拟医学治疗的形式，旨在欺骗患者/受试者，使其相信自己接受了活性治疗。在临床医学中，允许在特定情况下使用安慰剂，以确保患者得到照顾，并接受活性药物，即使情况并非如此。在临床研究中，安慰剂被广泛使用，因为它允许对积极干预进行基线比较。如果说安慰剂的使用在药理学试验中受到高度管制，那么外科手术研究的一系列特殊性使其使用非常成问题，并被认为不太有利。本文的目的是提出三个著名的情况下，使用安慰剂在手术试验，并进行伦理分析，其可接受性的赫尔辛基宣言作为主要的监管来源。
Placebo is a form of simulated medical treatment intended to deceive the patient/subject who believes that he/she received an active therapy. In clinical medicine, the use of placebo is allowed in particular circumstances to assure a patient that he is taken care of and that he/she receives an active drug, even if this is not the case. In clinical research placebo is widely used, as it allows a baseline comparison for the active intervention. If the use of placebo is highly regulated in pharmacological trials, surgery studies have a series of particularities that make its use extremely problematic and regarded less favorably. The purpose of this paper is to present three famous cases of placebo use in surgical trials and to perform an ethical analysis of their acceptability using the Declaration of Helsinki as a main regulatory source.