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安慰剂对照试验与《赫尔辛基宣言》。

Placebo-controlled trials and the Declaration of Helsinki.

作者信息

Lewis John A, Jonsson Bertil, Kreutz Gottfried, Sampaio Cristina, van Zwieten-Boot Barbara

机构信息

Hatch Green Cottage, Chartham Hatch, Canterbury, Kent CT4 7LP, UK.

出版信息

Lancet. 2002 Apr 13;359(9314):1337-40. doi: 10.1016/S0140-6736(02)08277-6.

DOI:10.1016/S0140-6736(02)08277-6
PMID:11965296
Abstract

A revised version of the Declaration of Helsinki, issued in October, 2000, remains a vital expression of medical ethics, and deserves unanimous support. A strict interpretation of the declaration seems to rule out clinical trials that use a placebo control group whenever licensed therapeutic methods already exist, preferring active controls. Although the efficacy of some new medicines can be satisfactorily established without the use of a placebo, for others the judicious use of placebo remains essential to establish their effectiveness.

摘要

2000年10月发布的《赫尔辛基宣言》修订版仍然是医学伦理的重要体现,值得一致支持。对该宣言的严格解读似乎排除了在已有许可治疗方法时使用安慰剂对照组的临床试验,而倾向于使用活性对照组。尽管有些新药的疗效无需使用安慰剂就能令人满意地确定,但对其他一些药物而言,明智地使用安慰剂对于确定其有效性仍然至关重要。

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Placebo-controlled trials and the Declaration of Helsinki.安慰剂对照试验与《赫尔辛基宣言》。
Lancet. 2002 Apr 13;359(9314):1337-40. doi: 10.1016/S0140-6736(02)08277-6.
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The Declaration of Helsinki and clinical trials: a focus on placebo-controlled trials in schizophrenia.《赫尔辛基宣言》与临床试验:聚焦精神分裂症的安慰剂对照试验
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Ethical principles and placebo-controlled trials - interpretation and implementation of the Declaration of Helsinki's placebo paragraph in medical research.伦理原则与安慰剂对照试验——《赫尔辛基宣言》安慰剂条款在医学研究中的解读与实施
BMC Med Ethics. 2018 Mar 15;19(1):24. doi: 10.1186/s12910-018-0262-9.
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The need to revise the Declaration of Helsinki.修订《赫尔辛基宣言》的必要性。
N Engl J Med. 1999 Aug 12;341(7):531-4. doi: 10.1056/NEJM199908123410713.
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The revision of the Declaration of Helsinki: past, present and future.《赫尔辛基宣言》的修订:过去、现在与未来
Br J Clin Pharmacol. 2004 Jun;57(6):695-713. doi: 10.1111/j.1365-2125.2004.02103.x.
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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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[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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Should the Declaration of Helsinki be revised?《赫尔辛基宣言》应该修订吗?
N Engl J Med. 1999 Dec 9;341(24):1851; author reply 1853. doi: 10.1056/NEJM199912093412414.
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Helsinki redux.赫尔辛基再现。
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[Compare new therapies with old, not with a placebo: a plea for revision of the Declaration of Helsinki].[将新疗法与旧疗法进行比较,而非与安慰剂比较:呼吁修订《赫尔辛基宣言》]
Ned Tijdschr Geneeskd. 2013;157(45):A6542.

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