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安慰剂的必要性和价值。

The necessity and the value of placebo.

作者信息

Singer Ernst A

机构信息

Department of Pharmacology, University of Vienna Medical School, Vienna, Austria.

出版信息

Sci Eng Ethics. 2004 Jan;10(1):51-6. doi: 10.1007/s11948-004-0062-0.

DOI:10.1007/s11948-004-0062-0
PMID:14986771
Abstract

The use of placebo in clinical trials has been repeatedly challenged as being unacceptable from an ethical point of view. The present paper responds to this criticism by taking up the issue in the light of the pertinent provisions of the Helsinki Declaration. Examples from different therapeutic areas are given that highlight the importance of placebo in situations in which its use is acceptable according to the Declaration. Particular emphasis is given to the question of active control trials, which, under conditions of low assay sensitivity, may become an ethically less acceptable approach than the use of a placebo control.

摘要

从伦理角度来看,在临床试验中使用安慰剂一直受到反复质疑,被认为是不可接受的。本文根据《赫尔辛基宣言》的相关规定来探讨这一问题,以回应这种批评。文中给出了不同治疗领域的例子,这些例子凸显了在《宣言》认为使用安慰剂可接受的情况下,安慰剂的重要性。文中特别强调了阳性对照试验的问题,即在检测灵敏度较低的情况下,与使用安慰剂对照相比,阳性对照试验在伦理上可能成为一种较不可接受的方法。

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The necessity and the value of placebo.安慰剂的必要性和价值。
Sci Eng Ethics. 2004 Jan;10(1):51-6. doi: 10.1007/s11948-004-0062-0.
2
Placebo in the investigation of psychotropic drugs, especially antidepressants.安慰剂在精神药物尤其是抗抑郁药研究中的应用。
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Placebo and the Helsinki Declaration--what to do?安慰剂与《赫尔辛基宣言》——该怎么办?
Sci Eng Ethics. 2004 Jan;10(1):81-93. doi: 10.1007/s11948-004-0066-9.
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Placebo: its action and place in health research today.安慰剂:其作用及在当今健康研究中的地位。
Sci Eng Ethics. 2004 Jan;10(1):9-13. doi: 10.1007/s11948-004-0056-y.
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Clinical trials: active control vs placebo--what is ethical?
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[Is the placebo still ethically acceptable and scientifically useful in clinical drug experimentation?].[在临床药物试验中,安慰剂在伦理上是否仍然可以接受且在科学上是否有用?]
Clin Ter. 1996 Nov;147(11):595-8.
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World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言:涉及人类受试者的医学研究伦理原则》
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引用本文的文献

1
Placebo: its action and place in health research today--summary and conclusions.安慰剂:其作用及在当今健康研究中的地位——总结与结论
Sci Eng Ethics. 2004 Jan;10(1):189-97. doi: 10.1007/s11948-004-0076-7.

本文引用的文献

1
World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言:涉及人类受试者的医学研究伦理原则》
JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053.
2
The 2000 revision of the Declaration of Helsinki: a step forward or more confusion?《赫尔辛基宣言》2000年修订版:是进步还是带来了更多困惑?
Lancet. 2001 Oct 27;358(9291):1449-53. doi: 10.1016/S0140-6736(01)06534-5.
3
The ethics of placebo-controlled trials--a middle ground.安慰剂对照试验的伦理学——一种折衷方案。
N Engl J Med. 2001 Sep 20;345(12):915-9. doi: 10.1056/NEJM200109203451211.
4
Helsinki discord? A controversial declaration.赫尔辛基分歧?一项有争议的声明。
JAMA. 2000 Dec 20;284(23):2983-5. doi: 10.1001/jama.284.23.2983.
5
Bilateral orchiectomy with or without flutamide for metastatic prostate cancer.双侧睾丸切除术联合或不联合氟他胺治疗转移性前列腺癌。
N Engl J Med. 1998 Oct 8;339(15):1036-42. doi: 10.1056/NEJM199810083391504.
6
Zolmitriptan (Zomig, 311C90), a novel dual central and peripheral 5HT1B/1D agonist: an overview of efficacy.佐米曲普坦(佐米格,311C90),一种新型的中枢和外周5HT1B/1D双重激动剂:疗效概述。
Cephalalgia. 1997 Oct;17 Suppl 18:28-40. doi: 10.1177/0333102497017S1805.
7
Treatment of septic shock with human monoclonal antibody HA-1A. A randomized, double-blind, placebo-controlled trial. CHESS Trial Study Group.用人源单克隆抗体HA-1A治疗感染性休克。一项随机、双盲、安慰剂对照试验。CHESS试验研究组。
Ann Intern Med. 1994 Jul 1;121(1):1-5. doi: 10.7326/0003-4819-121-1-199407010-00001.
8
The continuing unethical use of placebo controls.安慰剂对照的持续不道德使用。
N Engl J Med. 1994 Aug 11;331(6):394-8. doi: 10.1056/NEJM199408113310611.
9
Hazards of inference: the active control investigation.推断的风险:活性对照研究
Epilepsia. 1989;30 Suppl 1:S57-63; discussion S64-8. doi: 10.1111/j.1528-1157.1989.tb05816.x.
10
Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial.接受恩卡尼、氟卡尼或安慰剂治疗患者的死亡率和发病率。心律失常抑制试验。
N Engl J Med. 1991 Mar 21;324(12):781-8. doi: 10.1056/NEJM199103213241201.