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一项评估依西酞普兰治疗哮喘伴重性抑郁障碍患者的随机、双盲、安慰剂对照临床试验

A Randomized, Double-Blind, Placebo-Controlled Trial of Escitalopram in Patients with Asthma and Major Depressive Disorder.

机构信息

Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, Texas.

Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, Texas.

出版信息

J Allergy Clin Immunol Pract. 2018 Sep-Oct;6(5):1604-1612. doi: 10.1016/j.jaip.2018.01.010. Epub 2018 Mar 1.

Abstract

BACKGROUND

Depression is common in asthma and is associated with poor outcomes. However, antidepressant therapy in depressed patients with asthma has been the topic of little research.

OBJECTIVE

This study examined the impact of antidepressant treatment with escitalopram versus placebo on the Hamilton Rating Scale for Depression (HRSD), Inventory of Depressive Symptomatology-Self Report (IDS-SR), Asthma Control Questionnaire (ACQ), and oral corticosteroid use in patients with asthma and major depressive disorder (MDD).

METHODS

Single-site 12-week, randomized, double-blind, placebo-controlled, parallel-group trial of escitalopram (10 mg/d) was conducted in 139 outpatients with asthma and MDD. Randomization was stratified by oral corticosteroid use (≥3 bursts in past 12 months, yes or no) and baseline depressive symptom severity (HRSD score ≥ 20) (higher severity, n = 42) versus less than 3 bursts, HRSD score less than 20, or both (lower severity, n = 97). The primary data analysis was conducted using hierarchical linear modeling Version 7.01 on the higher and lower severity samples and post hoc was conducted on the combined sample.

RESULTS

Among the higher severity completers (n = 21), a significant reduction in the ACQ score (P = .04) and oral corticosteroid use (P = .04) was observed with escitalopram. In the combined sample, no significant differences were observed, but a trend toward greater reduction in the IDS-SR score was observed with escitalopram (P = .07). Side effects were comparable across groups.

CONCLUSIONS

The findings suggest that patients with more severe asthma and depression symptomatology may have a positive response, in terms of both asthma and depressive symptom reduction, to antidepressant treatment.

摘要

背景

哮喘患者中常见抑郁症,且与不良结局相关。然而,针对哮喘合并抑郁患者的抗抑郁治疗研究甚少。

目的

本研究旨在探讨与安慰剂相比,艾司西酞普兰治疗哮喘合并重性抑郁障碍(MDD)患者对汉密尔顿抑郁量表(HRSD)、抑郁症状自评量表-自我报告版(IDS-SR)、哮喘控制问卷(ACQ)和口服皮质类固醇使用的影响。

方法

本研究为单中心、12 周、随机、双盲、安慰剂对照、平行分组试验,共纳入 139 例哮喘合并 MDD 门诊患者,给予艾司西酞普兰(10 mg/d)或安慰剂治疗。根据口服皮质类固醇使用情况(过去 12 个月中≥3 次爆发,是或否)和基线抑郁症状严重程度(HRSD 评分≥20 分,高严重度,n=42)与皮质类固醇使用次数较少、HRSD 评分<20 分或两者兼有的患者(低严重度,n=97)进行分层随机分组。采用 Version 7.01 版分层线性模型对高严重度和低严重度完成者数据进行主要数据分析,并对合并样本进行事后分析。

结果

在高严重度完成者(n=21)中,艾司西酞普兰治疗后 ACQ 评分(P=0.04)和口服皮质类固醇使用率(P=0.04)显著降低。在合并样本中,差异无统计学意义,但艾司西酞普兰治疗后 IDS-SR 评分降低趋势更明显(P=0.07)。各组间不良反应无显著差异。

结论

研究结果提示,对于哮喘和抑郁症状更严重的患者,抗抑郁治疗可能在改善哮喘和抑郁症状方面有更好的效果。

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