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第二代抗抑郁药治疗美国抑郁症的疗效比较证据基础:美国食品和药物管理局审查的贝叶斯荟萃分析。

The comparative evidence basis for the efficacy of second-generation antidepressants in the treatment of depression in the US: A Bayesian meta-analysis of Food and Drug Administration reviews.

机构信息

University of Groningen, University Medical Center Groningen, Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion regulation, Groningen, The Netherlands.

University of Groningen, University Medical Center Groningen, Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion regulation, Groningen, The Netherlands; University of Groningen, Faculty of Behavioural and Social Sciences, Groningen, The Netherlands.

出版信息

J Affect Disord. 2018 Aug 1;235:393-398. doi: 10.1016/j.jad.2018.04.040. Epub 2018 Apr 6.

Abstract

BACKGROUND

Studies have shown similar efficacy of different antidepressants in the treatment of depression.

METHOD

Data of phase-2 and -3 clinical-trials for 16 antidepressants (levomilnacipran, desvenlafaxine, duloxetine, venlafaxine, paroxetine, escitalopram, vortioxetine, mirtazapine, venlafaxine XR, sertraline, fluoxetine, citalopram, paroxetine CR, nefazodone, bupropion, vilazodone), approved by the FDA for the treatment of depression between 1987 and 2016, were extracted from the FDA reviews that were used to evaluate efficacy prior to marketing approval, which are less liable to reporting biases. Meta-analytic Bayes factors, which quantify the strength of evidence for efficacy, were calculated. In addition, posterior pooled effect-sizes were calculated and compared with classical estimations.

RESULTS

The resulted Bayes factors showed that the evidence load for efficacy varied strongly across antidepressants. However, all tested drugs except for bupropion and vilazodone showed strong evidence for their efficacy. The posterior effect-size distributions showed variation across antidepressants, with the highest pooled estimated effect size for venlafaxine followed by paroxetine, and the lowest for bupropion and vilazodone.

LIMITATIONS

Not all published trials were included in the study.

CONCLUSIONS

The results illustrate the importance of considering both the effect size and the evidence-load when judging the efficacy of a treatment. In doing so, the currently employed Bayesian approach provided clear insights on top of those gained with traditional approaches.

摘要

背景

研究表明,不同的抗抑郁药在治疗抑郁症方面具有相似的疗效。

方法

从 FDA 对 1987 年至 2016 年间批准用于治疗抑郁症的 16 种抗抑郁药(左米那普仑、去甲文拉法辛、度洛西汀、文拉法辛、帕罗西汀、依地普仑、沃替西汀、米氮平、文拉法辛 XR、舍曲林、氟西汀、西酞普兰、帕罗西汀控释剂、奈法唑酮、安非他酮、维拉佐酮)的 2 期和 3 期临床试验数据进行了提取,这些数据来自 FDA 审查,用于评估上市前的疗效,这些数据不太容易受到报告偏倚的影响。计算了用于评估疗效的贝叶斯因子,以量化证据的强度。此外,还计算了后验汇总效应量,并与经典估计进行了比较。

结果

得到的贝叶斯因子表明,各种抗抑郁药的疗效证据强度差异很大。然而,除了安非他酮和维拉佐酮之外,所有测试的药物都显示出了对其疗效的有力证据。后验效应量分布显示出了抗抑郁药之间的差异,文拉法辛的总体估计效果最大,其次是帕罗西汀,而安非他酮和维拉佐酮的效果最低。

局限性

并非所有已发表的试验都包含在研究中。

结论

结果表明,在判断一种治疗方法的疗效时,考虑疗效大小和证据负荷都很重要。在这样做时,目前采用的贝叶斯方法除了提供传统方法获得的见解外,还提供了更清晰的见解。

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