评估去甲文拉法辛对改善重度抑郁症患者功能和幸福感结局指标的疗效：9项双盲、安慰剂对照、为期8周的临床试验的汇总分析。

Assessing the efficacy of desvenlafaxine for improving functioning and well-being outcome measures in patients with major depressive disorder: a pooled analysis of 9 double-blind, placebo-controlled, 8-week clinical trials.

作者信息

Soares Claudio N, Kornstein Susan G, Thase Michael E, Jiang Qin, Guico-Pabia Christine J

机构信息

Department of Psychiatry and Behavioural Neurosciences, Mood Disorders Division, McMaster University, Hamilton, Ontario, L8P 3B6, Canada.

出版信息

J Clin Psychiatry. 2009 Oct;70(10):1365-71. doi: 10.4088/JCP.09m05133blu.

DOI:10.4088/JCP.09m05133blu

PMID:19906341

Abstract

OBJECTIVE

To evaluate the effects of desvenlafaxine therapy on functioning and well-being in major depressive disorder (MDD).

METHOD

Total and individual item Sheehan Disability Scale (SDS) and 5-item World Health Organization Well-Being Index (WHO-5) scores from 8 double-blind, placebo-controlled, 8-week desvenlafaxine clinical trials were pooled. Scores on the 17-item Hamilton Depression Rating Scale (HDRS(17)) work/activities and Montgomery-Asberg Depression Rating Scale (MADRS) lassitude items were pooled from 9 studies. Outpatients with DSM-IV MDD were randomly assigned to fixed (5 studies; 50, 100, 200, or 400 mg/d; n = 1,342) or flexible (4 studies, 100-400 mg/d; n = 463) doses of desvenlafaxine or placebo (n = 1,108). Data from each patient's final evaluation were analyzed for the total population and for individual dose groups from the fixed-dose studies and were compared between groups using analysis of covariance.

RESULTS

Compared with placebo, desvenlafaxine therapy resulted in significantly greater improvements in SDS total score (-2.0) and individual items regarding work (-0.6), social life/leisure activities (-0.8), and family life/home responsibilities (-0.7; P < .001 for all comparisons), as well as WHO-5 total score (1.7) and individual items (good spirits [0.4], calm/relaxed [0.4], active/vigorous [0.3], fresh/rested [0.3], and interest [0.3]; P < .001 for all comparisons). Desvenlafaxine treatment resulted in significant improvements on the HDRS(17) work/activities (-0.2; P < .001) and MADRS lassitude (-0.3; P < .001) items compared with placebo. Significant differences were observed for the individual fixed-dose groups on all outcomes (P < .05); there was no evidence of a dose-response relationship.

CONCLUSIONS

Desvenlafaxine therapy resulted in significant improvements in the functioning and well-being among MDD patients.

摘要

目的

评估去甲文拉法辛治疗对重度抑郁症（MDD）患者功能和幸福感的影响。

方法

汇总了8项双盲、安慰剂对照、为期8周的去甲文拉法辛临床试验中Sheehan功能障碍量表（SDS）总分及各单项得分以及世界卫生组织5项幸福指数（WHO-5）得分。从9项研究中汇总了17项汉密尔顿抑郁量表（HDRS(17)）工作/活动项得分及蒙哥马利-阿斯伯格抑郁量表（MADRS）疲倦项得分。将符合《精神疾病诊断与统计手册》第四版（DSM-IV）标准的门诊MDD患者随机分配至固定剂量组（5项研究；50、100、200或400 mg/d；n = 1342）或灵活剂量组（4项研究，100 - 400 mg/d；n = 463）接受去甲文拉法辛治疗或安慰剂治疗（n = 1108）。对每位患者最终评估的数据进行总体分析，并对固定剂量研究中的各剂量组进行分析，采用协方差分析比较组间差异。

结果

与安慰剂相比，去甲文拉法辛治疗使SDS总分显著改善（-2.0），在工作（-0.6）、社交生活/休闲活动（-0.8）和家庭生活/家庭责任（-0.7；所有比较P <.001）等单项上也有显著改善，WHO-5总分（1.7）及各单项（精神状态良好[0.4]、平静/放松[0.4]、积极/精力充沛[0.3]、神清气爽/休息良好[0.3]和兴趣[0.3]；所有比较P <.001）同样显著改善。与安慰剂相比，去甲文拉法辛治疗使HDRS(17)工作/活动项（-0.2；P <.001）和MADRS疲倦项（-0.3；P <..001）显著改善。各固定剂量组在所有结局指标上均有显著差异（P <.05）；未发现剂量-反应关系。