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睾酮和生长激素补充剂对社区居住老年男性影响的持续性:HORMA试验

Durability of the effects of testosterone and growth hormone supplementation in older community-dwelling men: the HORMA Trial.

作者信息

Sattler Fred R, Bhasin Shalender, He Jiaxiu, Yarasheski Kevin E, Binder Ellen F, Schroeder E Todd, Castaneda-Sceppa Carmen, Kawakubo Miwa, Roubenoff Ronenn, Dunn Matthew, Hahn Chris, Stewart Yolanda, Martinez Carmen, Azen Stanley P

机构信息

Department of Medicine, University of Southern CaliforniaDivision of Biokinesiology, University of Southern California, Los Angeles, CASection of Endocrinology, Diabetes, and Nutrition, Boston University, Boston, MADepartment of Preventive Medicine, University of Southern California, Los Angeles, CADepartment of Medicine, Washington University, St Louis, MOJean Mayer USDA Human Nutrition Research Center on Aging of Tufts University, Boston, MADepartment of Urology, University of Southern California, Los Angeles, CA, USA.

出版信息

Clin Endocrinol (Oxf). 2011 Jul;75(1):103-11. doi: 10.1111/j.1365-2265.2011.04014.x.

Abstract

OBJECTIVES

To determine the durability of anabolic effects and adverse events (AEs) after stopping testosterone and growth hormone supplementation in older men.

DESIGN

Secondary analysis of a double-masked, randomized controlled trial of testosterone gel (5 or 10 g/daily) plus rhGH (0, 3 or 5 μg/kg/day) with follow-up of outcomes 3 months later.

PARTICIPANTS

A total of 108 community-dwelling 65- to 90-year-old men.

MEASUREMENTS

Testosterone and IGF-1 levels, body composition (DEXA), 1-repetition maximum (1-RM) strength, stair-climbing power, quality-of-life (QOL) and activity questionnaires, AEs.

RESULTS

Despite improvements in body composition during treatment, residual benefits 3 months later (week 28) were variable. For participants with improvements exceeding their week-17 median changes, benefits were sustained at week 28 for lean body mass (1·45 ± 1·63 kg, 45% of week-17 values, P < 0·0001 vs baseline), appendicular skeletal muscle mass (ASMM, 0·71 ± 1·01 kg, 42%, P < 0·0001), total fat (-1·06 ± 2·18 kg, 40%, P < 0·0001) and trunk fat (-0·89 ± 1·42 kg, 50%, P < 0·0001); retention of ASMM was associated with greater week-16 protein intake (P = 0·01). For 1-RM strength, 39%-43% of week-17 improvements (P ≤ 0·05) were retained and associated with better week-17 strength (P < 0·0001), change in testosterone from week 17-to 28 (P = 0·004) and baseline PASE (P = 0·04). Framingham 10-year cardiovascular risks were low (~14%), did not worsen and improved by week 28 (P = 0·0002). The hypothalamic-pituitary-gonadal axis recovered completely.

CONCLUSIONS

Durable improvements in muscle mass, strength and fat mass were retained 3 months after discontinuing hormone supplementation in participants with greater than median body composition changes during treatment, but not in others with smaller gains. AEs largely resolved after intervention discontinuation. Additional strategies may be needed to sustain or augment muscle mass and strength gains achieved during short-term hormone therapy.

摘要

目的

确定老年男性停止补充睾酮和生长激素后合成代谢效应及不良事件(AE)的持续性。

设计

对一项双盲随机对照试验进行二次分析,该试验使用睾酮凝胶(5或10克/天)加重组人生长激素(0、3或5微克/千克/天),3个月后对结果进行随访。

参与者

共有108名65至90岁的社区居住男性。

测量指标

睾酮和胰岛素样生长因子-1水平、身体成分(双能X线吸收法)、1次重复最大负荷(1-RM)力量、爬楼梯能力、生活质量(QOL)和活动问卷、不良事件。

结果

尽管治疗期间身体成分有所改善,但3个月后(第28周)的残余益处各不相同。对于改善超过第17周中位数变化的参与者,第28周时瘦体重(1.45±1.63千克,为第17周值的45%,与基线相比P<0.0001)、四肢骨骼肌质量(ASMM,0.71±1.01千克,42%,P<0.0001)、总脂肪(-1.06±2.18千克,40%,P<0.0001)和躯干脂肪(-0.89±1.42千克,50%,P<0.0001)的益处得以维持;ASMM的保留与第16周更高的蛋白质摄入量相关(P=0.01)。对于1-RM力量,第17周改善的39%-43%得以保留(P≤0.05),并与第17周更好的力量(P<0.0001)、第17周至28周睾酮的变化(P=0.004)和基线PASE(P=0.04)相关。弗雷明汉10年心血管风险较低(约14%),未恶化且在第28周有所改善(P=0.0002)。下丘脑-垂体-性腺轴完全恢复。

结论

在治疗期间身体成分变化大于中位数的参与者中,停止激素补充3个月后,肌肉质量、力量和脂肪量的持久改善得以保留,但在获益较小的其他参与者中则未保留。干预停止后不良事件大多得到解决。可能需要额外的策略来维持或增强短期激素治疗期间获得的肌肉质量和力量增加。

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本文引用的文献

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Adverse events associated with testosterone administration.与睾酮治疗相关的不良反应。
N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30.
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Effects of an oral growth hormone secretagogue in older adults.口服生长激素促分泌素对老年人的影响。
J Clin Endocrinol Metab. 2009 Apr;94(4):1198-206. doi: 10.1210/jc.2008-0632. Epub 2009 Jan 27.
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Low serum testosterone and mortality in older men.老年男性血清睾酮水平低与死亡率
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