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复发预防和残留症状:对舍曲林治疗重度抑郁障碍、广泛性焦虑障碍、社交焦虑障碍和强迫症的安慰剂对照维持研究的更深入分析。

Relapse prevention and residual symptoms: a closer analysis of placebo-controlled continuation studies with escitalopram in major depressive disorder, generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder.

机构信息

Psychiatric Research Unit, Frederiksborg General Hospital, Dyrehavevej 48, DK-3400 Hillerød, Denmark.

出版信息

J Clin Psychiatry. 2010 Feb;71(2):121-9. doi: 10.4088/JCP.08m04749blu. Epub 2009 Dec 1.

Abstract

OBJECTIVE

Analyses of data from 4 relapse-prevention studies with escitalopram were conducted in order to compare patients with and without residual symptoms with regard to relapse rates and global illness during double-blind, 24-week continuation periods.

METHOD

Clinical Global Impressions-Severity of Illness scores and relapse status in 4 studies published from 2005 to 2007, 1 each in major depressive disorder (MDD), generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder (OCD), were analyzed using mixed-effects model repeated measures as a function of Montgomery-Asberg Depression Rating Scale (MADRS) scores on items 1, 3, and 7 at randomization.

RESULTS

All studies showed a statistically significant (P < .0001) standardized effect size of about 0.7 for escitalopram versus placebo, with a number needed to treat approximately 4. Patients with residual symptoms (MADRS score > 0) and without residual symptoms (MADRS score = 0) at the start of continuation treatment were defined by how patients scored on 3 core items of the MADRS: depressed mood (observed), inner or psychic tension, and lassitude. At randomization, patients with a residual symptom were globally more ill than patients without such a symptom. Patients who did not continue active treatment worsened, even if they were initially free of a residual symptom. In contrast, patients who continued receiving escitalopram remained stable or further improved, regardless of residual symptoms or diagnosis. No clear picture emerged regarding whether patients with residual symptoms had a higher relapse rate.

CONCLUSIONS

The presence of residual symptoms is associated with significantly worse overall illness severity in all 4 diagnostic groups and with a higher (although not significantly) risk of relapse for patients with MDD or OCD. The greatest difference in all of the studies was between patients treated with escitalopram (relapse rates ~ 20%) and placebo (relapse rates of about 50%).

摘要

目的

对 4 项与依西酞普兰相关的预防复发研究的数据进行分析,以比较残留症状患者与无残留症状患者的复发率和双盲 24 周延续治疗期间的整体疾病严重程度。

方法

使用混合效应模型重复测量法,对 4 项分别发表于 2005 年至 2007 年的研究中的临床总体印象-疾病严重程度评分和复发情况进行分析,这 4 项研究涉及重度抑郁症(MDD)、广泛性焦虑症、社交焦虑症和强迫症(OCD)。分析的指标为随机分组时蒙哥马利-艾斯伯格抑郁评定量表(MADRS)第 1、3 和 7 项的评分。

结果

所有研究均显示依西酞普兰与安慰剂相比具有统计学意义(P<0.0001)的标准效应量约为 0.7,需要治疗的患者人数约为 4 人。在延续治疗开始时存在残留症状(MADRS 评分>0)和无残留症状(MADRS 评分=0)的患者,是根据 MADRS 的 3 个核心项目的评分来定义的:抑郁心境(观察到的)、内心或精神紧张和乏力。随机分组时,有残留症状的患者总体上比没有这种症状的患者病情更严重。即使最初没有残留症状,未继续接受有效治疗的患者病情也会恶化。相比之下,无论是否存在残留症状或诊断如何,继续接受依西酞普兰治疗的患者病情保持稳定或进一步改善。对于存在残留症状的患者是否有更高的复发率,并未得出明确的结论。

结论

在所有 4 个诊断组中,残留症状的存在与整体疾病严重程度显著相关,对于 MDD 或 OCD 患者,复发的风险更高(尽管无统计学意义)。在所有研究中,最大的差异在于接受依西酞普兰治疗的患者(复发率约为 20%)与安慰剂(复发率约为 50%)之间。

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