与肌肉性能和身体功能相关的变化在与移动性受限的老年男性睾丸激素治疗中的临床意义。
Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation.
机构信息
Section of Endocrinology, Diabetes, and Nutrition, Boston University School of Medicine and Boston Medical Center, 670 Albany Street, Boston, MA 02118, USA.
出版信息
J Gerontol A Biol Sci Med Sci. 2011 Oct;66(10):1090-9. doi: 10.1093/gerona/glr100. Epub 2011 Jun 22.
CONTEXT
Testosterone in Older Men with Mobility Limitations Trial determined the effects of testosterone on muscle performance and physical function in older men with mobility limitation. Trial's Data and Safety Monitoring Board recommended enrollment cessation due to increased frequency of adverse events in testosterone arm. The changes in muscle performance and physical function were evaluated in relation to participant's perception of change.
METHODS
Men aged 65 years and older, with mobility limitation, total testosterone 100-350 ng/dL, or free testosterone less than 50 pg/mL, were randomized to placebo or 10 g testosterone gel daily for 6 months. Primary outcome was leg-press strength. Secondary outcomes included chest-press strength, stair-climb, 40-m walk, muscle mass, physical activity, self-reported function, and fatigue. Proportions of participants exceeding minimally important difference in study arms were compared.
RESULTS
Of 209 randomized participants, 165 had follow-up efficacy measures. Mean (SD) age was 74 (5.4) years and short physical performance battery score 7.7 (1.4). Testosterone arm exhibited greater improvements in leg-press strength, chest-press strength and power, and loaded stair-climb than placebo. Compared with placebo, significantly greater proportion of men receiving testosterone improved their leg-press and chest-press strengths (43% vs 18%, p = .01) and stair-climbing power (28% vs 10%, p = .03) more than minimally important difference. Increases in leg-press strength and stair-climbing power were associated with changes in testosterone levels and muscle mass. Physical activity, walking speed, self-reported function, and fatigue did not change.
CONCLUSIONS
Testosterone administration in older men with mobility limitation was associated with patient-important improvements in muscle strength and stair-climbing power. Improvements in muscle strength and only some physical function measures should be weighed against the risk of adverse events in this population.
背景
《有行动障碍的老年男性睾酮试验》旨在研究睾酮对有行动障碍的老年男性肌肉功能和身体机能的影响。试验数据和安全监测委员会建议停止招募，因为睾酮组的不良事件发生率增加。肌肉功能和身体机能的变化与参与者的感知变化有关。
方法
年龄在 65 岁及以上、有行动障碍、总睾酮水平在 100-350ng/dL 或游离睾酮水平低于 50pg/mL 的男性，随机分为安慰剂组或每天使用 10g 睾酮凝胶治疗组，疗程为 6 个月。主要终点为腿蹬力。次要终点包括卧推力量、爬楼梯、40 米行走、肌肉质量、身体活动、自我报告功能和疲劳。比较了研究组中超过最小有意义差异的参与者比例。
结果
在 209 名随机参与者中，有 165 名进行了随访疗效评估。平均（标准差）年龄为 74（5.4）岁，简易体能测试电池评分为 7.7（1.4）。与安慰剂组相比，睾酮组的腿蹬力、卧推力量和功率以及负重爬楼梯能力均有显著改善。与安慰剂相比，接受睾酮治疗的男性中，腿蹬力和卧推力量（43%比 18%，p=0.01）以及爬楼梯功率（28%比 10%，p=0.03）显著改善超过最小有意义差异的比例更高。腿蹬力和爬楼梯能力的增加与睾酮水平和肌肉质量的变化相关。身体活动、行走速度、自我报告功能和疲劳均未发生变化。
结论
在有行动障碍的老年男性中，给予睾酮治疗与肌肉力量和爬楼梯能力的显著改善相关。在该人群中，应权衡不良事件的风险与改善肌肉力量和部分身体功能测量的获益。
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