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一项西酞普兰治疗老年心力衰竭伴发重性抑郁障碍的双盲、安慰剂对照治疗试验:安慰剂效应和心理症状的相关性。

A double-blind, placebo-controlled treatment trial of citalopram for major depressive disorder in older patients with heart failure: the relevance of the placebo effect and psychological symptoms.

机构信息

Department and Institute of Psychiatry, Clinics Hospital, Faculty of Medicine, University of Sao Paulo, SP, Brazil.

出版信息

Contemp Clin Trials. 2009 May;30(3):205-11. doi: 10.1016/j.cct.2009.01.007. Epub 2009 Jan 24.

Abstract

BACKGROUND

Little is known about the treatment of depression in older patients with heart failure. This study was developed to investigate the effectiveness of antidepressant treatment for major depressive disorder (MDD) in the elderly with heart failure.

METHODS

We enrolled 72 older outpatients with ejection fraction <50 and diagnosed with MDD by the structured clinical interview for DSM-IV. Thirty-seven patients, 19 on citalopram and 18 on placebo, initiated an 8-week double-blind treatment phase. Measurements were performed with the 31-item Hamilton Rating Scale for Depression (Ham-D-31), the Montgomery-Asberg rating scale (MADRS) and the Systematic Assessment for Treatment Emergent Effects (SAFTEE). A psychiatrist followed up the patients weekly, performing a consultation for about 20 min to field complaints after the measurements.

RESULTS

A trend toward superiority of citalopram over placebo in reducing depression was observed in MADRS scores (15.05+9.74 vs 9.44+9.25, P=.082) but not on HAM-D scores. The depressive symptomatology significantly decreased in both groups (P < .001). The high rate of placebo response during the double-blind phase (56.3%) led us to conclude the study at the interim analysis with 37 patients.

CONCLUSION

Citalopram treatment of MDD in older patients with heart failure is well-tolerated with low rates of side effects, but was not significantly more effective than placebo in the treatment of depression. Weekly psychiatric follow-up including counseling may contribute to the improvement of depression in this population. Scales weighted on psychological symptoms such as the MADRS are possibly better suited to measure depression severity and improvement in patients with heart failure.

摘要

背景

对于老年心力衰竭患者的抑郁症治疗,目前知之甚少。本研究旨在探讨抗抑郁药治疗老年心力衰竭伴发的重度抑郁症(MDD)的疗效。

方法

我们纳入了 72 名射血分数<50 的老年门诊患者,通过 DSM-IV 定式临床访谈诊断为 MDD。37 名患者,19 名服用西酞普兰,18 名服用安慰剂,开始进行 8 周的双盲治疗阶段。采用 31 项汉密尔顿抑郁量表(Ham-D-31)、蒙哥马利-阿斯伯格抑郁评定量表(MADRS)和治疗中出现的不良反应的系统评估量表(SAFTEE)进行评估。一名精神科医生每周对患者进行随访,在测量后进行约 20 分钟的咨询,以了解患者的不良反应。

结果

MADRS 评分显示西酞普兰降低抑郁的疗效有优于安慰剂的趋势(15.05±9.74 比 9.44±9.25,P=0.082),但在 Ham-D 评分上无显著差异。两组患者的抑郁症状均显著减轻(P<0.001)。双盲阶段安慰剂的高应答率(56.3%)导致我们在中期分析时仅纳入了 37 名患者。

结论

西酞普兰治疗老年心力衰竭伴发 MDD 患者的耐受性良好,副作用发生率低,但在治疗抑郁方面并不显著优于安慰剂。每周进行包括咨询的精神科随访可能有助于改善该人群的抑郁症状。基于心理症状的量表(如 MADRS)可能更适合测量心力衰竭患者的抑郁严重程度和改善情况。

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