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广泛性焦虑症中的安慰剂反应:其对临床试验结果的影响。

Placebo response in generalized anxiety: its effect on the outcome of clinical trials.

作者信息

Schweizer E, Rickels K

机构信息

Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia 19104-2649, USA.

出版信息

J Clin Psychiatry. 1997;58 Suppl 11:30-8.

PMID:9363046
Abstract

The development of new treatments for generalized anxiety disorder increasingly has been sabotaged by a high placebo-response rate. As a consequence, and in contrast to the surge of approvals for new antidepressants, only one new anxiolytic has been approved by the U.S. Food and Drug Administration in the past 15 years. This article presents a brief review of factors that contribute to the placebo response in treatment studies of generalized anxiety. Since anxiety is a normal emotion that is sensitive to a variety of life stresses, it is particularly difficult to achieve the primary goal of a clinical trial, which is to extract the "signal" of a drug effect from the "noise" of background fluctuations in symptoms. Data from the published literature and from the authors' research unit concerning placebo-response trends are reviewed.

摘要

广泛性焦虑症新疗法的研发越来越受到高安慰剂反应率的破坏。因此,与新型抗抑郁药获批数量激增形成对比的是,在过去15年里,美国食品药品监督管理局仅批准了一种新型抗焦虑药。本文简要回顾了在广泛性焦虑症治疗研究中导致安慰剂反应的因素。由于焦虑是一种对各种生活压力敏感的正常情绪,因此特别难以实现临床试验的主要目标,即从症状背景波动的“噪音”中提取药物效应的“信号”。本文回顾了已发表文献和作者研究单位关于安慰剂反应趋势的数据。

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1
Placebo response in generalized anxiety: its effect on the outcome of clinical trials.广泛性焦虑症中的安慰剂反应:其对临床试验结果的影响。
J Clin Psychiatry. 1997;58 Suppl 11:30-8.
2
[Treatment of generalized anxiety: new pharmacologic approaches].[广泛性焦虑症的治疗:新的药理学方法]
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[Clinical evaluation of new anxiolytic drugs (author's transl)].新型抗焦虑药物的临床评估(作者译)
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Development of a patient-reported assessment to identify placebo responders in a generalized anxiety disorder trial.开发一种患者报告的评估方法,以在广泛性焦虑症试验中识别安慰剂反应者。
J Psychiatr Res. 2009 Oct;43(15):1224-30. doi: 10.1016/j.jpsychires.2009.04.001. Epub 2009 May 6.
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Placebo response and antidepressant clinical trial outcome.安慰剂反应与抗抑郁药物临床试验结果。
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INFLUENCE OF STUDY DESIGN ON TREATMENT RESPONSE IN ANXIETY DISORDER CLINICAL TRIALS.研究设计对焦虑症临床试验中治疗反应的影响。
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Survey of investigators' opinions on the acceptability of interactions with patients participating in clinical trials.调查研究人员对参与临床试验的患者进行互动的可接受性的意见。
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Primary care patients in psychiatric clinical trials: a pilot study using videoconferencing.精神科临床试验中的初级保健患者:一项使用视频会议的试点研究。
Ann Gen Psychiatry. 2007 Oct 4;6:24. doi: 10.1186/1744-859X-6-24.