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新版《欧洲药品管理局抗抑郁药指南:研究人员和药物开发者指南》

The new European Medicines Agency guideline on antidepressants: a guide for researchers and drug developers.

机构信息

Office of Therapies for Neurological and Psychiatric Disorders, European Medicines Agency, Amsterdam, Netherlands.

Unit Neurology, Psychiatry, Ophthalmology, Federal Institute of Drugs and Medical Devices, Bonn, Germany.

出版信息

Eur Psychiatry. 2023 Dec 15;67(1):e2. doi: 10.1192/j.eurpsy.2023.2479.

Abstract

According to the World Health Organization (WHO), depressive disorders are currently considered as one of the most disabling medical conditions in the world with one of the highest disability-adjusted life years [1] and this situation has apparently been further worsened during the COVID-19 pandemic [2]. Up to two thirds of patients with major depressive disorders (MDD) do not achieve full remission following an adequate first line standard of care and/or experience residual symptoms such as anxiety, impaired cognition, fatigue, sleep disturbance, or anhedonia [3]. Several attempts are often needed to find the most suitable treatment [4]. Thus, there is a need for medicinal products with better efficacy (e.g., faster onset of action, higher rates of response and remission), improved safety and/or more personalised profiles [5].

摘要

根据世界卫生组织(WHO)的说法,抑郁障碍目前被认为是世界上最具致残性的疾病之一,其伤残调整生命年(DALY)[1]最高,而在 COVID-19 大流行期间[2],这种情况显然进一步恶化。多达三分之二的重度抑郁症(MDD)患者在接受充分的一线标准治疗后未达到完全缓解,/或仍存在焦虑、认知障碍、疲劳、睡眠障碍或快感缺失等残留症状[3]。通常需要多次尝试才能找到最合适的治疗方法[4]。因此,需要具有更好疗效(例如,起效更快、反应和缓解率更高)、提高安全性和/或更个性化特征的药物产品[5]。

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本文引用的文献

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Lancet. 2023 Mar 4;401(10378):714-716. doi: 10.1016/S0140-6736(23)00264-7. Epub 2023 Feb 10.
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Expectancy in placebo-controlled trials of psychedelics: if so, so what?安慰剂对照试验中对致幻剂的期待:如果是这样,那又怎样?
Psychopharmacology (Berl). 2022 Oct;239(10):3047-3055. doi: 10.1007/s00213-022-06221-6. Epub 2022 Sep 5.
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Sex Differences in Blood-Brain Barrier Transport of Psychotropic Drugs.精神药物血脑屏障转运中的性别差异。
Front Behav Neurosci. 2022 May 23;16:844916. doi: 10.3389/fnbeh.2022.844916. eCollection 2022.
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The promises and perils of psychedelic pharmacology for psychiatry.精神药理学在精神病学中的承诺与危险。
Nat Rev Drug Discov. 2022 Jun;21(6):463-473. doi: 10.1038/s41573-022-00421-7. Epub 2022 Mar 17.

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