解决抗抑郁药疗效问题：重度抑郁症的效应大小。
Solving the antidepressant efficacy question: effect sizes in major depressive disorder.
机构信息
Facultad de Medicina, Hospital Clinico, Universidad de Chile, Santiago, Chile.
出版信息
Clin Ther. 2011 Dec;33(12):B49-61. doi: 10.1016/j.clinthera.2011.11.019. Epub 2011 Dec 2.
BACKGROUND
Numerous reviews and meta-analyses of the antidepressant literature in major depressive disorders (MDD), both acute and maintenance, have been published, some claiming that antidepressants are mostly ineffective and others that they are mostly effective, in either acute or maintenance treatment.
OBJECTIVE
The aims of this study were to review and critique the latest and most notable antidepressant MDD studies and to conduct our own reanalysis of the US Food and Drug Administration database studies specifically analyzed by Kirsch et al.
METHODS
We gathered effect estimates of each MDD study. In our reanalysis of the acute depression studies, we corrected analyses for a statistical floor effect so that relative (instead of absolute) effect size differences were calculated. We also critiqued a recent meta-analysis of the maintenance treatment literature.
RESULTS
Our reanalysis showed that antidepressant benefit is seen not only in severe depression but also in moderate depression and confirmed a lack of benefit for antidepressants over placebo in mild depression. Relative antidepressant versus placebo benefit increased linearly from 5% in mild depression to 12% in moderate depression to 16% in severe depression. The claim that antidepressants are completely ineffective, or even harmful, in maintenance treatment studies involves unawareness of the enriched design effect, which, in that analysis, was used to analyze placebo efficacy. The same problem exists for the standard interpretation of those studies, although they do not prove antidepressant efficacy either, since they are biased in favor of antidepressants.
CONCLUSIONS
In sum, we conclude that antidepressants are effective in acute depressive episodes that are moderate to severe but are not effective in mild depression. Except for the mildest depressive episodes, correction for the statistical floor effect proves that antidepressants are effective acutely. These considerations only apply to acute depression, however. For maintenance, the long-term efficacy of antidepressants is unproven, but the data do not support the conclusion that they are harmful.
背景
大量关于重性抑郁障碍（MDD）急性期和维持期抗抑郁药物疗效的综述和荟萃分析已发表，一些声称抗抑郁药大多无效，而另一些则声称抗抑郁药大多有效，无论是在急性期还是维持期治疗中。
目的
本研究旨在回顾和评价最新的、最显著的抗抑郁药 MDD 研究，并对 Kirsch 等人专门分析的美国食品和药物管理局数据库研究进行重新分析。
方法
我们收集了每项 MDD 研究的疗效估计值。在我们对急性期抑郁研究的重新分析中，我们对分析进行了校正，以消除统计地板效应，从而计算相对（而不是绝对）的疗效差异。我们还对最近的维持治疗文献荟萃分析进行了评价。
结果
我们的重新分析表明，抗抑郁药不仅对重度抑郁症有效，对中度抑郁症也有效，并证实了抗抑郁药在轻度抑郁症中与安慰剂相比没有益处。抗抑郁药与安慰剂的相对获益从轻度抑郁症的 5%、中度抑郁症的 12%、重度抑郁症的 16%呈线性增加。关于抗抑郁药在维持治疗研究中完全无效，甚至有害的说法，涉及到对富集设计效应的认识不足，在该分析中，富集设计效应被用于分析安慰剂的疗效。同样的问题也存在于对这些研究的标准解释中，尽管它们也不能证明抗抑郁药的疗效，因为它们偏向于抗抑郁药。
结论
总的来说，我们的结论是，抗抑郁药在中度到重度的急性抑郁发作中是有效的，但在轻度抑郁中无效。除了最轻微的抑郁发作外，对统计地板效应的校正证明抗抑郁药在急性期是有效的。然而，这些考虑仅适用于急性抑郁症。对于维持治疗，抗抑郁药的长期疗效尚未得到证实，但数据并不支持抗抑郁药有害的结论。
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