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难治性抑郁症第三步治疗的预期效果:一项关于艾司西酞普兰的前瞻性开放性研究。

What to expect from a third step in treatment resistant depression: A prospective open study on escitalopram.

作者信息

Souery Daniel, Calati Raffaella, Papageorgiou Konstantinos, Juven-Wetzler Alzbeta, Gailledreau Joël, Modavi David, Sentissi Othman, Pitchot William, Papadimitriou George N, Dikeos Dimitris, Montgomery Stuart, Kasper Siegfried, Zohar Joseph, Serretti Alessandro, Mendlewicz Julien

机构信息

a Laboratoire de Psychologie Médicale, Université Libre de Bruxelles, and Centre Européen de Psychologie Médicale-PsyPluriel , Brussels , Belgium.

b IRCCS Centro S. Giovanni di Dio, Fatebenefratelli , Brescia , Italy.

出版信息

World J Biol Psychiatry. 2015 Oct;16(7):472-82. doi: 10.3109/15622975.2014.987814. Epub 2014 Dec 23.

Abstract

OBJECTIVES

Only few studies investigated treatment strategies for treatment resistant depression (TRD). The objective of this multicentre study was to evaluate TRD patients who did not respond to at least two antidepressants.

METHODS

A total of 417 patients, who failed to respond to a previous retrospectively assessed antidepressant (AD1), were firstly included in a 6-week venlafaxine treatment (AD2); secondly, those who failed to respond were treated for further 6 weeks with escitalopram (AD3).

RESULTS

Out of 417 patients who had failed to respond to previous treatment (AD1), 334 completed treatment with venlafaxine to prospectively define TRD. In the intent to treat (ITT) population in the first phase of the trial (AD2), responders to venlafaxine were 151 (36.21%) out of which remitters were 83 (19.90%). After phase one, 170 non-responders, defined as TRD, were included in the second phase and 157 completed the course. Of the 170 ITT entering the second phase (AD3), responders to escitalopram were 71 (41.76%) out of which remitters were 39 (22.94%). After the third treatment, patients showed a dropout rate of 7.65% and a rate of presence of at least one serious adverse event of 19.18%.

CONCLUSIONS

Relevant rates of response and remission may be observed after a third line treatment in patients resistant to two previous treatments. A relevant limitation of this study was represented by the design: naturalistic, non-randomized, open-label, without a control sample and with unblinded raters.

摘要

目的

仅有少数研究探讨了难治性抑郁症(TRD)的治疗策略。这项多中心研究的目的是评估对至少两种抗抑郁药无反应的TRD患者。

方法

共有417名对先前回顾性评估的抗抑郁药(AD1)无反应的患者,首先纳入为期6周的文拉法辛治疗(AD2);其次,对无反应者再用艾司西酞普兰治疗6周(AD3)。

结果

在417名对先前治疗(AD1)无反应的患者中,334名完成了文拉法辛治疗,以前瞻性地定义TRD。在试验第一阶段(AD2)的意向性治疗(ITT)人群中,文拉法辛的反应者有151名(36.21%),其中缓解者有83名(19.90%)。第一阶段后,170名被定义为TRD的无反应者纳入第二阶段,157名完成了疗程。在进入第二阶段(AD3)的170名ITT患者中,艾司西酞普兰的反应者有71名(41.76%),其中缓解者有39名(22.94%)。经过第三次治疗后,患者的脱落率为7.65%,至少出现一种严重不良事件的发生率为19.18%。

结论

在对先前两种治疗耐药的患者进行三线治疗后,可观察到相关的反应率和缓解率。本研究的一个相关局限性在于设计:自然主义、非随机、开放标签、无对照样本且评估者未设盲。

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