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人口统计学变量、设计特征和主要抑郁障碍和双相抑郁的随机、安慰剂对照、单药治疗试验的效应大小。

Demographic variables, design characteristics, and effect sizes of randomized, placebo-controlled, monotherapy trials of major depressive disorder and bipolar depression.

机构信息

Clinical Trials Network and Institute and Depression Clinical and Research Program, Massachusetts General Hospital, One Bowdoin Sq, 6th Fl, Boston, MA 02114

出版信息

J Clin Psychiatry. 2016 May;77(5):e619-24. doi: 10.4088/JCP.14r09767.

DOI:10.4088/JCP.14r09767
PMID:27249092
Abstract

OBJECTIVE

The aim of this work is to compare the efficacy of pharmacologic agents for the treatment of major depressive disorder (MDD) and bipolar depression.

DATA SOURCES

MEDLINE/PubMed databases were searched for studies published in English between January 1980 and September 2014 by cross-referencing the search term placebo with each of the antidepressant agents identified and with bipolar. The search was supplemented by manual bibliography review.

STUDY SELECTION

We selected double-blind, randomized, placebo-controlled trials of antidepressant monotherapies for the treatment of MDD and of oral drug monotherapies for the treatment of bipolar depression. 196 trials in MDD and 19 trials in bipolar depression were found eligible for inclusion in our analysis.

DATA EXTRACTION

Data were extracted by one of the authors and checked for accuracy by a second one. Data extracted included year of publication, number of patients randomized, probability of receiving placebo, duration of the trial, baseline symptom severity, dosing schedule, study completion rates, and clinical response rates.

RESULTS

Response rates for drug versus placebo in trials of MDD and bipolar depression were 52.7% versus 37.5% and 54.7% versus 40.5%, respectively. The random-effects meta-analysis indicated that drug therapy was more effective than placebo in both MDD (risk ratio for response = 1.373; P < .001) and bipolar depression (risk ratio = 1.257; P < .001) trials. The meta-regression analysis suggested a statistically significant difference in the risk ratio of responding to drug versus placebo between MDD and bipolar depression trials in favor of MDD (P = .008).

CONCLUSIONS

Although a statistically significantly greater treatment effect size was noted in MDD relative to bipolar depression studies, the absolute magnitude of the difference was numerically small. Therefore, the present study suggests no clinically significant differences in the overall short-term efficacy of pharmacologic monotherapies for MDD and bipolar depression.

摘要

目的

本研究旨在比较治疗重度抑郁症(MDD)和双相抑郁的药物疗效。

资料来源

通过交叉引用抗抑郁药与每个确定的抗抑郁药和双相的安慰剂,对 1980 年 1 月至 2014 年 9 月发表的英文研究进行了 MEDLINE/PubMed 数据库检索。通过手动文献回顾补充了检索。

研究选择

我们选择了双盲、随机、安慰剂对照的 MDD 单药治疗和双相抑郁的口服药物单药治疗的试验。共发现 196 项 MDD 试验和 19 项双相抑郁试验符合纳入分析标准。

资料提取

作者之一提取资料,另一作者核对准确性。提取的数据包括发表年份、随机分组患者数、接受安慰剂的概率、试验持续时间、基线症状严重程度、剂量方案、研究完成率和临床反应率。

结果

MDD 和双相抑郁试验中药物与安慰剂的反应率分别为 52.7%对 37.5%和 54.7%对 40.5%。随机效应荟萃分析表明,药物治疗在 MDD(反应风险比=1.373;P<0.001)和双相抑郁(风险比=1.257;P<0.001)试验中均优于安慰剂。Meta 回归分析提示,MDD 和双相抑郁试验中药物与安慰剂反应的风险比存在统计学显著差异,有利于 MDD(P=0.008)。

结论

尽管 MDD 研究的治疗效果大小明显大于双相抑郁研究,但差异的绝对幅度在数值上较小。因此,本研究提示在 MDD 和双相抑郁的短期药物单药治疗总体疗效方面,并无明显的临床差异。

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