Trivedi Madhukar H, Corey-Lisle Patricia K, Guo Zhenchao, Lennox Richard D, Pikalov Andrei, Kim Edward
UT Southwestern Medical Center at Dallas, Texas 75390-9119, USA.
Int Clin Psychopharmacol. 2009 May;24(3):133-8. doi: 10.1097/YIC.0b013e3283277614.
Major depressive disorder (MDD) is associated with significant functional impairment. This post-hoc analysis of data from two randomized trials assessed the impact of response status on functioning in MDD. Patients with at least one historical treatment failure followed by an inadequate response after 8 weeks of prospective open-label treatment with escitalopram, fluoxetine, paroxetine-CR, sertraline, or venlafaxine-XR plus single-blind placebo were randomized to 6 weeks of double-blind treatment with adjunctive placebo or adjunctive aripiprazole. At the end of double-blind treatment, patients were defined as: in remission [>or=50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score with MADRS <or=10]; with a response without remission (>or=50% reduction in MADRS with MADRS >10); or with a nonresponse (all others). Functional status was assessed with the Sheehan Disability Scale. Of the 679 patients, 144 were in remission, 44 had a response without remission, and 491 had a nonresponse. Mean improvements in the Sheehan Disability Scale total and item scores were significantly greater in patients in remission versus those with a response without remission (P<0.02) as well as nonresponse (P<0.001). Structural Equation Modeling found that efficacy (Hamilton Rating Scale for Depression scores) did not significantly correlate with functioning in this study. In conclusion, MDD patients achieving symptomatic remission experience greater functional improvements than those respond without remission. Functioning may be a distinctly different outcome from symptom reduction. Treatments focused on producing high remission rates may improve patient functioning over and above that seen with patients who only achieve response.
重度抑郁症(MDD)与显著的功能损害相关。这项对两项随机试验数据的事后分析评估了缓解状态对MDD患者功能的影响。既往至少有一次治疗失败,且在接受依他普仑、氟西汀、帕罗西汀控释片、舍曲林或文拉法辛缓释片进行为期8周的前瞻性开放标签治疗加单盲安慰剂治疗后反应不佳的患者,被随机分配接受为期6周的双盲治疗,分别联合安慰剂或阿立哌唑。在双盲治疗结束时,患者被定义为:缓解(蒙哥马利-艾斯伯格抑郁评定量表(MADRS)评分降低≥50%且MADRS≤10);有反应但未缓解(MADRS降低≥50%且MADRS>10);或无反应(其他所有情况)。使用希恩残疾量表评估功能状态。在679例患者中,144例缓解,44例有反应但未缓解,491例无反应。与有反应但未缓解的患者(P<0.02)以及无反应的患者(P<0.001)相比,缓解患者的希恩残疾量表总分及各项目得分的平均改善显著更大。结构方程模型发现,在本研究中疗效(汉密尔顿抑郁量表评分)与功能之间无显著相关性。总之,实现症状缓解的MDD患者比有反应但未缓解的患者功能改善更大。功能改善可能是与症状减轻明显不同的结果。专注于产生高缓解率的治疗可能比仅实现反应的患者更能改善患者功能。