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[在针对精神疾病患者进行的临床试验中,临床前研究扮演着怎样的角色?]

[What role for paraclinical investigations within clinical trials conducted in psychiatric patients?].

作者信息

Kaladjian A, Adida M, Simon N, Belzeaux R, Blin O, Fakra E, Azorin J-M

机构信息

Pôle de Psychiatrie des Adultes, CHU Robert Debré, Avenue du Général Koenig, 51092 Reims Cedex, France.

SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.

出版信息

Encephale. 2016 Dec;42(6S):S47-S50. doi: 10.1016/S0013-7006(17)30054-4.

Abstract

As in the usual care of patients, paraclinical investigations have today only a very modest role in clinical trials in psychiatry, mainly to complete the pre-therapeutical assessments prior to inclusion of subjects or to monitor treatment tolerance. Yet, the accumulation of data in neurosciences suggests the next emergence of biomarkers, whose interest is that they are closely associated to the biological disturbances underlying psychiatric illnesses, and that they are accessible by means of technological tools such as imaging devices. These tools allow to explore the effects on brain of psychotropic medications, such as antidepressants, antipsychotics, or mood stabilizers, in relation to their therapeutic action. The obtained results allow to consider the use of such biomarkers in clinical trials in addition to more conventional approaches. In particular, they could be used as targets to measure brain response to treatment in association with clinical response, to predict a therapeutic response from the neurofunctional characteristics of patients, or to establish the safety profile of drugs on the nervous system. The use of such biomarkers in clinical trials would help to better define the explored populations and their characteristics, as well as the variables to assess, and to better measure the impact of the treatments and their potential harmful effects on the nervous system.

摘要

与患者的常规护理一样,目前辅助临床检查在精神病学临床试验中的作用非常有限,主要用于在纳入受试者之前完成治疗前评估或监测治疗耐受性。然而,神经科学领域的数据积累表明,生物标志物即将出现,其优势在于它们与精神疾病潜在的生物学紊乱密切相关,并且可以通过成像设备等技术工具获取。这些工具能够探究抗抑郁药、抗精神病药或心境稳定剂等精神药物对大脑的影响及其治疗作用。所获得的结果使得除了更传统的方法外,还可以考虑在临床试验中使用此类生物标志物。特别是,它们可以作为与临床反应相关的测量大脑对治疗反应的靶点,根据患者的神经功能特征预测治疗反应,或确定药物对神经系统的安全性。在临床试验中使用此类生物标志物将有助于更好地界定所研究的人群及其特征,以及要评估的变量,并更好地衡量治疗的影响及其对神经系统的潜在有害作用。

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