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睾酮治疗对肥胖合并重度阻塞性睡眠呼吸暂停男性睡眠和呼吸的影响:一项随机安慰剂对照试验。

Effects of testosterone therapy on sleep and breathing in obese men with severe obstructive sleep apnoea: a randomized placebo-controlled trial.

机构信息

Endocrine and Cardiometabolic Research Group, NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.

出版信息

Clin Endocrinol (Oxf). 2012 Oct;77(4):599-607. doi: 10.1111/j.1365-2265.2012.04413.x.

DOI:10.1111/j.1365-2265.2012.04413.x
PMID:22512435
Abstract

STUDY OBJECTIVES

High doses of short-term testosterone have been shown to acutely worsen sleep-disordered breathing in men with obstructive sleep apnoea (OSA). The effects of lower, near-conventional doses of testosterone in obese men with OSA may differ over the longer term but have not been systematically studied. We assessed sleep and breathing effects of near-conventional testosterone treatment as an adjunct to weight loss in obese men with severe OSA.

DESIGN

An 18-week randomized, double-blind, placebo-controlled, parallel group trial in 67 men.

INTERVENTIONS

All subjects were placed on a hypocaloric diet and then received intramuscular injections of 1000 mg testosterone undecanoate or placebo at 0, 6 and 12 weeks.

MEASUREMENTS AND RESULTS

Sleep and breathing were measured by nocturnal polysomnography at 0, 7 and 18 weeks. Testosterone, compared to placebo, worsened the oxygen desaturation index (ODI) by 10·3 events/h (95%CI, 0·8-19·8 events/h; P = 0·03) and nocturnal hypoxaemia (sleep time with oxygen saturation <90%, SpO(2) T90%) by 6·1% (95%CI, 1·5-10·6; P = 0·01) at 7 weeks. Testosterone therapy did not alter ODI (4·5, -5·4 to 14·4 events/h; P = 0·36) or SpO(2) T90% at 18 weeks (2·9, -1·9-7·7%; P = 0·23) compared to placebo. The testosterone treatment effects on ODI and SpO(2) T90% were not influenced by baseline testosterone concentrations (testosterone by treatment interactions, all P > 0·35). Blood testosterone concentrations did not correlate with ODI or SpO(2) T90% (all P > 0·19).

CONCLUSIONS

Testosterone therapy in obese men with severe OSA mildly worsens sleep-disordered breathing in a time-limited manner, irrespective of initial testosterone concentrations. This time-dependency was not related to testosterone concentrations.

TRIAL REGISTRATION

www.anzctr.org.au Identifier: ACTRN1260-6000404527.

摘要

研究目的

已有研究表明,短期大剂量睾酮可使阻塞性睡眠呼吸暂停(OSA)患者的睡眠呼吸紊乱急性恶化。但对于肥胖的 OSA 患者,较低的常规剂量睾酮可能会在较长时间内产生不同的影响,而这些影响尚未得到系统研究。我们评估了在严重 OSA 的肥胖男性中,将常规剂量的睾酮作为减肥的辅助手段对睡眠和呼吸的影响。

设计

这是一项为期 18 周的、随机、双盲、安慰剂对照、平行组试验,共纳入了 67 名男性。

干预措施

所有受试者均接受低热量饮食,然后在 0、6 和 12 周时接受肌内注射 1000mg 十一酸睾酮或安慰剂。

测量和结果

在 0、7 和 18 周时通过夜间多导睡眠图测量睡眠和呼吸情况。与安慰剂相比,睾酮使氧减饱和指数(ODI)恶化了 10.3 次/小时(95%CI,0.8-19.8 次/小时;P=0.03),使夜间低氧血症(睡眠时血氧饱和度<90%,SpO2T90%)恶化了 6.1%(95%CI,1.5-10.6;P=0.01),这些变化在第 7 周时发生。与安慰剂相比,睾酮治疗并未改变 ODI(4.5,-5.4 至 14.4 次/小时;P=0.36)或 SpO2T90%(2.9,-1.9-7.7%;P=0.23)在第 18 周时发生。ODI 和 SpO2T90%的睾酮治疗效果不受基线睾酮浓度的影响(治疗与睾酮相互作用,所有 P>0.35)。血睾酮浓度与 ODI 或 SpO2T90%无相关性(所有 P>0.19)。

结论

在严重 OSA 的肥胖男性中,睾酮治疗会在有限的时间内轻度恶化睡眠呼吸紊乱,而与初始睾酮浓度无关。这种时间依赖性与睾酮浓度无关。

试验注册

www.anzctr.org.au 标识符:ACTRN1260-6000404527。

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