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外科研究中的安慰剂:基于案例的伦理分析与实际影响

Placebo in Surgical Research: A Case-Based Ethical Analysis and Practical Consequences.

作者信息

Hostiuc Sorin, Rentea Irina, Drima Eduard, Negoi Ionut

机构信息

Department of Legal Medicine and Bioethics, Faculty of Medicine, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; National Institute of Legal Medicine, 042122 Bucharest, Romania.

Faculty of Medicine, Carol Davila University of Medicine and Pharmacy, 020021 Bucharest, Romania.

出版信息

Biomed Res Int. 2016;2016:2627181. doi: 10.1155/2016/2627181. Epub 2016 Aug 10.

Abstract

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.

摘要

安慰剂是一种模拟医疗手段,旨在欺骗那些认为自己接受了有效治疗的患者/受试者。在临床医学中,特定情况下允许使用安慰剂,以确保患者觉得自己得到了照料且正在接受有效药物治疗,即便实际并非如此。在临床研究中,安慰剂被广泛使用,因为它能为活性干预措施提供基线对照。虽然在药物试验中对安慰剂的使用有严格规定,但外科手术研究存在一系列特殊情况,这使得安慰剂的使用极具问题且不那么被看好。本文旨在介绍外科手术试验中使用安慰剂的三个著名案例,并以《赫尔辛基宣言》作为主要监管依据,对其可接受性进行伦理分析。

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