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抗抑郁药治疗成人急性重度抑郁症的时间-效应、剂量效应分析及影响因素。

Analysis of Time-Course, Dose-Effect, and Influencing Factors of Antidepressants in the Treatment of Acute Adult Patients With Major Depression.

机构信息

Center for Drug of Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Shanghai Mental Health Center, Shanghai, China.

出版信息

Int J Neuropsychopharmacol. 2020 Feb 1;23(2):76-87. doi: 10.1093/ijnp/pyz062.

DOI:10.1093/ijnp/pyz062
PMID:31774497
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7094001/
Abstract

OBJECTIVE

Model-based meta-analysis was used to describe the time-course and dose-effect relationships of antidepressants and also simultaneously investigate the impact of various factors on drug efficacy.

METHODS

This study is a reanalysis of a published network meta-analysis. Only placebo-controlled trials were included in this study. The change rate in depression rating scale scores from baseline was used as an efficacy indicator because a continuous variable is more likely to reflect subtle differences in efficacy between drugs.

RESULTS

A total 230 studies containing 64 346 patients were included in the analysis. The results showed that the number of study sites (single or multi-center) and the type of setting (inpatient or noninpatient) are important factors affecting the efficacy of antidepressants. After deducting the placebo effect, the maximum pure drug efficacy value of inpatients was 18.4% higher than that of noninpatients, and maximum pure drug efficacy value of single-center trials was 10.2% higher than that of multi-central trials. Amitriptyline showed the highest drug efficacy. The remaining 18 antidepressants were comparable or had little difference. Within the approved dose range, no significant dose-response relationship was observed. However, the time-course relationship is obvious for all antidepressants. In terms of safety, with the exception of amitriptyline, the dropout rate due to adverse events of other drugs was not more than 10% higher than that of the placebo group.

CONCLUSION

The number of study sites and the type of setting are significant impact factors for the efficacy of antidepressants. Except for amitriptyline, the other 18 antidepressants have little difference in efficacy and safety.

摘要

目的

采用基于模型的荟萃分析来描述抗抑郁药的时程和剂量-效应关系,并同时探讨各种因素对药物疗效的影响。

方法

本研究是对已发表的网络荟萃分析进行的再分析。本研究仅纳入安慰剂对照试验。采用抑郁量表评分的基线变化率作为疗效指标,因为连续变量更有可能反映药物疗效之间的细微差异。

结果

共有 230 项研究,包含 64346 名患者纳入分析。结果显示,研究地点的数量(单中心或多中心)和设置类型(住院或非住院)是影响抗抑郁药疗效的重要因素。扣除安慰剂效应后,住院患者的最大纯药物疗效值比非住院患者高 18.4%,单中心试验的最大纯药物疗效值比多中心试验高 10.2%。阿米替林显示出最高的药物疗效。其余 18 种抗抑郁药的疗效相当或差异较小。在批准的剂量范围内,未观察到明显的剂量-反应关系。然而,所有抗抑郁药的时程关系都很明显。在安全性方面,除阿米替林外,其他药物因不良反应导致的停药率与安慰剂组相比不超过 10%的差异。

结论

研究地点的数量和设置类型是抗抑郁药疗效的重要影响因素。除阿米替林外,其余 18 种抗抑郁药在疗效和安全性方面差异较小。

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