Sheehan David V, Mancini Michele, Wang Jianing, Berggren Lovisa, Cao Haijun, Dueñas Héctor José, Yue Li
Morsani College of Medicine, University of South Florida, Tampa, Florida, USA.
Eli Lilly and Company, Bad Homburg, Germany.
Hum Psychopharmacol. 2016 Jan;31(1):53-63. doi: 10.1002/hup.2500. Epub 2015 Sep 1.
We compared functional impairment outcomes assessed with Sheehan Disability Scale (SDS) after treatment with duloxetine versus selective serotonin reuptake inhibitors (SSRIs) in patients with major depressive disorder.
Data were pooled from four randomized studies comparing treatment with duloxetine and SSRIs (three double blind and one open label). Analysis of covariance, with last-observation-carried-forward approach for missing data, explored treatment differences between duloxetine and SSRIs on SDS changes during 8 to 12 weeks of acute treatment for the intent-to-treat population. Logistic regression analysis examined the predictive capacity of baseline patient characteristics for remission in functional impairment (SDS total score ≤ 6 and SDS item scores ≤ 2) at endpoint.
Included were 2193 patients (duloxetine n = 1029; SSRIs n = 835; placebo n = 329). Treatment with duloxetine and SSRIs resulted in significantly (p < 0.01) greater improvements in the SDS total score versus treatment with placebo. Higher SDS (p < 0.0001) or 17-item Hamilton Depression Rating Scale baseline scores (p < 0.01) predicted lower probability of functional improvement after treatment with duloxetine or SSRIs. Female gender (p ≤ 0.05) predicted higher probability of functional improvement after treatment with duloxetine or SSRIs.
Treatment with SSRIs and duloxetine improved functional impairment in patients with major depressive disorder. Higher SDS or 17-item Hamilton Depression Rating Scale baseline scores predicted less probability of SDS improvement; female gender predicted better improvement in functional impairment at endpoint.
我们比较了度洛西汀与选择性5-羟色胺再摄取抑制剂(SSRIs)治疗重度抑郁症患者后,使用希恩残疾量表(SDS)评估的功能损害结果。
数据来自四项比较度洛西汀与SSRIs治疗的随机研究(三项双盲研究和一项开放标签研究)。采用协方差分析,并对缺失数据采用末次观察结转法,探讨度洛西汀与SSRIs在急性治疗8至12周期间,对意向性治疗人群SDS变化的治疗差异。逻辑回归分析检验了基线患者特征对终点时功能损害缓解(SDS总分≤6且SDS项目得分≤2)的预测能力。
纳入2193例患者(度洛西汀组n = 1029;SSRIs组n = 835;安慰剂组n = 329)。与安慰剂治疗相比,度洛西汀和SSRIs治疗使SDS总分有显著(p < 0.01)更大改善。较高的SDS(p < 0.0001)或17项汉密尔顿抑郁量表基线评分(p < 0.01)预测度洛西汀或SSRIs治疗后功能改善的可能性较低。女性(p≤0.05)预测度洛西汀或SSRIs治疗后功能改善的可能性较高。
SSRIs和度洛西汀治疗改善了重度抑郁症患者的功能损害。较高的SDS或17项汉密尔顿抑郁量表基线评分预测SDS改善的可能性较小;女性预测终点时功能损害改善更好。