Pfizer Inc., Collegeville, Pennsylvania 19426, USA.
Int Clin Psychopharmacol. 2012 Jan;27(1):1-7. doi: 10.1097/YIC.0b013e32834c2488.
The objective of this study was to explore the relationship between assessments of functional impairment, emotional well-being, and depression symptoms. Data were pooled from 3530 outpatients with major depressive disorder enrolled in 10 desvenlafaxine clinical trials. The primary outcome measures included (a) the 17-item Hamilton Rating Scale for Depression (HAM-D17) as a measure of depressive symptom severity and (b) the Sheehan Disability Scale (SDS) and five-item World Health Organization Well-Being Index (WHO-5) as measures of functional impairment and well-being. A linear regression model was used to identify the SDS and WHO-5 values that equate to the predetermined clinically relevant three-point difference between active treatment and placebo on the HAM-D17. A receiver operating characteristic analysis was conducted to determine the SDS score that equates to a remission of depression symptoms (i.e. HAM-D17≤7). An approximate three-point difference between active treatment and placebo on the SDS (2.8) and WHO-5 (2.5) was determined to be clinically relevant in relation to improvements in depressive symptoms. An SDS of less than or equal to 7 was equivalent to a remission of depression symptoms, providing a definition of functional remission. A better understanding of the relationship between depressive symptoms and functional impairment and well-being may provide clinicians with a more comprehensive means of assessing treatment effects in major depressive disorder.
这项研究的目的是探讨功能障碍评估、情绪健康和抑郁症状之间的关系。数据来自 10 项去甲文拉法辛临床研究中的 3530 名重度抑郁症门诊患者。主要结局指标包括：(a) 汉密尔顿抑郁量表 17 项版本（HAM-D17），用于评估抑郁症状严重程度；(b) 舍恩残疾量表（SDS）和五项世界卫生组织幸福指数（WHO-5），用于评估功能障碍和幸福感。线性回归模型用于确定 SDS 和 WHO-5 的值，这些值与 HAM-D17 上活性治疗与安慰剂之间预定的临床相关的三分差异相对应。进行了接收器工作特征分析，以确定 SDS 评分，该评分与抑郁症状缓解（即 HAM-D17≤7）相对应。SDS（2.8）和 WHO-5（2.5）上活性治疗与安慰剂之间约三分的差异被确定与抑郁症状的改善相关具有临床意义。SDS 小于或等于 7 等同于抑郁症状的缓解，为功能缓解提供了定义。更好地了解抑郁症状与功能障碍和幸福感之间的关系，可能为临床医生提供一种更全面的评估重度抑郁症治疗效果的方法。
