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抑郁症和痴呆患者的安慰剂对照抗抑郁研究的系统评价和荟萃分析。

A systematic review and meta-analysis of placebo-controlled antidepressant studies in people with depression and dementia.

机构信息

Department of Psychiatry, University of California San Francisco, San Francisco, California, USA.

出版信息

J Am Geriatr Soc. 2011 Apr;59(4):577-85. doi: 10.1111/j.1532-5415.2011.03355.x. Epub 2011 Mar 31.

DOI:10.1111/j.1532-5415.2011.03355.x
PMID:21453380
Abstract

OBJECTIVES

To determine the efficacy of antidepressants in people with depression and dementia.

DESIGN

A systematic review and meta-analysis based on a literature search of Medline and Cochrane Trials Registry for acute-phase, double-blind, placebo-controlled, parallel-design, random-assignment trials of antidepressants marketed in the United States.

SETTING

Outpatient clinics, inpatient units, residential settings.

PARTICIPANTS

People with criterion-based diagnoses of dementia and depression.

MEASUREMENTS

Numbers of participants randomized; baseline and end point depression scale scores; and response, remission, and discontinuation rates were extracted. Random-effects meta-analyses were performed for response and remission rates, change scores using standardized mean differences, and discontinuation rates. Sensitivity analyses were planned to examine effects of depression diagnosis, severity, and trial duration.

RESULTS

Seven trials with 330 participants met selection criteria. The odds ratio (OR) for six trials reporting response rates with antidepressant and placebo was 2.12 (95% confidence interval (CI)=0.95-4.70; Z=1.84, P=.07). The OR for five trials reporting remission rates was 1.97 (95% CI=0.85-4.55; Z=1.59, P=.11). Both analyses demonstrated heterogeneity. The standardized mean difference in trials was 0.29 (95% CI=0.02-0.60, Z=1.86, P=.06). This analysis did not demonstrate significant heterogeneity. Adverse event discontinuation rates (9.0%) were not significantly higher with drug than placebo (6.0%), and were low.

CONCLUSION

The evidence for antidepressant treatment of people with depression and dementia, although suggestive, does not confirm efficacy. All of the trials were significantly underpowered to detect differences, resulting in inconclusive findings. Variable trial methods, comorbid conditions, and differences in antidepressants employed further confounded findings.

摘要

目的

确定抗抑郁药治疗抑郁症合并痴呆患者的疗效。

设计

基于对 Medline 和 Cochrane 临床试验注册库的文献检索,进行抗抑郁药的系统评价和荟萃分析。检索对象为美国上市的抗抑郁药的急性期、双盲、安慰剂对照、平行设计、随机分组临床试验。

环境

门诊、住院病房、居住环境。

参与者

符合基于标准的痴呆和抑郁症诊断的患者。

测量方法

随机分组的参与者人数;基线和终点抑郁量表评分;以及反应率、缓解率和停药率。对反应率和缓解率、使用标准化均数差值的变化评分以及停药率进行随机效应荟萃分析。计划进行敏感性分析以检查抑郁诊断、严重程度和试验持续时间的影响。

结果

符合选择标准的 7 项试验共纳入 330 名参与者。报告抗抑郁药与安慰剂反应率的 6 项试验的比值比(OR)为 2.12(95%置信区间(CI)为 0.95-4.70;Z=1.84,P=0.07)。报告缓解率的 5 项试验的 OR 为 1.97(95% CI 为 0.85-4.55;Z=1.59,P=0.11)。这两个分析均显示存在异质性。试验中的标准化均数差值为 0.29(95% CI 为 0.02-0.60,Z=1.86,P=0.06)。此分析未显示出显著的异质性。药物组与安慰剂组的不良事件停药率(9.0%)无显著差异,且较低。

结论

虽然有迹象表明抗抑郁药治疗抑郁症合并痴呆患者有效,但证据并不确定。所有试验的检测能力均明显不足,无法检测到差异,导致结果不确定。试验方法的多变性、合并疾病以及所使用的抗抑郁药的差异进一步使结果复杂化。

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