Yang Wei-Cheng, Lin Ching-Hua, Wang Fu-Chiang, Lu Mei-Jou
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, No.130, Kaisyuan 2nd Road, Lingya District, Kaohsiung City, 80276, Taiwan.
Department of Psychiatry, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, No.100, Shihcyuan 1st Road, Sanmin District, Kaohsiung City, 80708, Taiwan.
BMC Psychiatry. 2017 Aug 25;17(1):309. doi: 10.1186/s12888-017-1471-3.
The aim of this study was to explore the relationships between depressive symptoms and health-related quality of life (HRQOL) measurements for inpatients with major depressive disorder (MDD) before and after 6-week fluoxetine treatment, and to elucidate the factors related to the HRQOL changes.
A total of 131 inpatients with MDD were enrolled to receive 20 mg of fluoxetine for 6 weeks. Symptom severity and adverse events were assessed at weeks 0, 1, 2, 3, 4, and 6 using the 17-item Hamilton Depression Rating Scale (HAMD-17) and UKU Side Effect Rating Scale, respectively. HRQOL was measured using the Short Form 36 (SF-36), including 8 subscales, physical component summary (PCS) and mental component summary (MCS), at baseline and week 6. Spearman's coefficient, Cohen's d, and multiple linear regression model were used for statistical analysis.
One hundred and six patients completing all measures at weeks 0 and 6 entered the analysis. HAMD-17 negatively correlated with SF-36 at baseline and week 6. The HAMD-17 had a larger effect size than SF-36. MCS, rather than PCS, showed statistically significant improvement. After using multiple linear regression analysis, age at onset, HAMD-17 score change, and number of adverse events reported during the trial period were related to MCS change after adjusting for confounding variables.
Fluoxetine treatment was associated with an improvement in depressive symptomology and HRQOL. Depressive symptoms had a greater extent of change than HRQOL. Clinicians must consider the negative effects of adverse events caused by antidepressants on the improvement of HRQOL.
http://clinicaltrials.gov , NCT01075529 , retrospectively registered 24/2/2010.
本研究旨在探讨重度抑郁症（MDD）住院患者在接受为期6周的氟西汀治疗前后，抑郁症状与健康相关生活质量（HRQOL）测量指标之间的关系，并阐明与HRQOL变化相关的因素。
共纳入131例MDD住院患者，给予20mg氟西汀治疗6周。分别在第0、1、2、3、4和6周使用17项汉密尔顿抑郁量表（HAMD-17）和UKU副作用评定量表评估症状严重程度和不良事件。在基线和第6周使用简短健康调查问卷（SF-36）测量HRQOL，该问卷包括8个分量表、身体成分总结（PCS）和心理成分总结（MCS）。采用Spearman系数、Cohen's d和多元线性回归模型进行统计分析。
106例在第0周和第6周完成所有测量的患者进入分析。在基线和第6周时，HAMD-17与SF-36呈负相关。HAMD-17的效应量大于SF-36。MCS而非PCS显示出统计学上的显著改善。在调整混杂变量后，使用多元线性回归分析发现，发病年龄、HAMD-17评分变化以及试验期间报告的不良事件数量与MCS变化相关。
氟西汀治疗与抑郁症状和HRQOL的改善相关。抑郁症状的变化程度大于HRQOL。临床医生必须考虑抗抑郁药引起的不良事件对HRQOL改善的负面影响。
http://clinicaltrials.gov ，NCT01075529 ，于2010年2月24日追溯注册。
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