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睾酮治疗对2型糖尿病合并代谢综合征男性患者葡萄糖代谢及症状的影响:一项随机对照临床试验的系统评价和荟萃分析

Effects of testosterone treatment on glucose metabolism and symptoms in men with type 2 diabetes and the metabolic syndrome: a systematic review and meta-analysis of randomized controlled clinical trials.

作者信息

Grossmann Mathis, Hoermann Rudolf, Wittert Gary, Yeap Bu B

机构信息

Department of Medicine Austin Health, University of Melbourne, Heidelberg, Vic., Australia.

Endocrine Unit, Austin Health, Heidelberg, Vic., Australia.

出版信息

Clin Endocrinol (Oxf). 2015 Sep;83(3):344-51. doi: 10.1111/cen.12664. Epub 2014 Dec 29.

Abstract

CONTEXT

The effects of testosterone treatment on glucose metabolism and other outcomes in men with type 2 diabetes (T2D) and/or the metabolic syndrome are controversial.

OBJECTIVE

To perform a systematic review and meta-analysis of placebo-controlled double-blind randomized controlled clinical trials (RCT) of testosterone treatment in men with T2D and/or the metabolic syndrome.

DATA SOURCES

A systematic search of RCTs was conducted using Medline, Embase and the Cochrane Register of controlled trials from inception to July 2014 followed by a manual review of the literature.

STUDY SELECTION

Eligible studies were published placebo-controlled double-blind RCTs published in English.

DATA EXTRACTION

Two reviewers independently selected studies, determined study quality and extracted outcome and descriptive data.

DATA SYNTHESIS

Of the 112 identified studies, seven RCTs including 833 men were eligible for the meta-analysis. In studies using a simple linear equation to calculate the homeostatic model assessment of insulin resistance (HOMA1), testosterone treatment modestly improved insulin resistance, compared to placebo, pooled mean difference (MD) -1·58 [-2·25, -0·91], P < 0·001. The treatment effect was nonsignificant for RCTs using a more stringent computer-based equation (HOMA2), MD -0·19 [-0·86, 0·49], P = 0·58). Testosterone treatment did not improve glycaemic (HbA1c) control, MD -0·15 [-0·39, 0·10], P = 0·25, or constitutional symptoms, Aging Male Symptom score, MD -2·49 [-5·81, 0·83], P = 0·14).

CONCLUSIONS

This meta-analysis does not support the routine use of testosterone treatment in men with T2D and/or the metabolic syndrome without classical hypogonadism. Additional studies are needed to determine whether hormonal interventions are warranted in selected men with T2D and/or the metabolic syndrome.

摘要

背景

睾酮治疗对2型糖尿病(T2D)男性和/或代谢综合征患者的糖代谢及其他结局的影响存在争议。

目的

对睾酮治疗T2D男性和/或代谢综合征的安慰剂对照双盲随机对照临床试验(RCT)进行系统评价和荟萃分析。

数据来源

使用Medline、Embase和Cochrane对照试验注册库对RCT进行系统检索,检索时间从建库至2014年7月,随后对文献进行人工筛选。

研究选择

纳入的研究为已发表的英文安慰剂对照双盲RCT。

数据提取

两名研究者独立选择研究、评估研究质量并提取结局和描述性数据。

数据合成

在112项纳入研究中,7项RCT(共833名男性)符合荟萃分析的纳入标准。在使用简单线性方程计算胰岛素抵抗稳态模型评估(HOMA1)的研究中,与安慰剂相比,睾酮治疗可适度改善胰岛素抵抗,合并平均差(MD)为-1.58[-2.25,-0.91],P<0.001。对于使用更严格的基于计算机方程(HOMA2)的RCT,治疗效果不显著,MD为-0.19[-0.86,0.49],P=0.58)。睾酮治疗未改善血糖(糖化血红蛋白)控制,MD为-0.15[-0.39,0.10],P=0.25,也未改善体质症状(衰老男性症状评分),MD为-2.49[-5.81,0.83],P=0.14)。

结论

本荟萃分析不支持在无经典性腺功能减退的T2D男性和/或代谢综合征患者中常规使用睾酮治疗。需要进一步研究以确定在特定的T2D男性和/或代谢综合征患者中是否有必要进行激素干预。

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