Effects of Testosterone Treatment in Older Men.
Effects of Testosterone Treatment in Older Men.
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DOI：
10.1056/nejmoa1506119
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发表时间：
2016-02-18
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影响因子：
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通讯作者：
Testosterone Trials Investigators
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作者：
Snyder PJ;Bhasin S;Cunningham GR;Matsumoto AM;Stephens-Shields AJ;Cauley JA;Gill TM;Barrett-Connor E;Swerdloff RS;Wang C;Ensrud KE;Lewis CE;Farrar JT;Cella D;Rosen RC;Pahor M;Crandall JP;Molitch ME;Cifelli D;Dougar D;Fluharty L;Resnick SM;Storer TW;Anton S;Basaria S;Diem SJ;Hou X;Mohler ER 3rd;Parsons JK;Wenger NK;Zeldow B;Landis JR;Ellenberg SS;Testosterone Trials Investigators
血清睾酮浓度随着男性年龄的增长而下降，但老年男性提高睾酮水平的益处尚未确定。我们将790名65岁或65岁以上的男性，血清睾酮浓度低于275 ng/dl，症状提示雄激素过少，接受睾酮凝胶或安慰剂凝胶治疗1年。每个人都参加了三项试验中的一项或多项-性功能试验，身体功能试验和活力试验。还在所有参与者中评价了每个单独试验的主要结局。对于19至40岁的男性，替吉奥治疗将血清睾酮水平提高到中等正常范围。睾酮水平的增加与性心理每日问卷（Psychosexual Daily Questionnaire）评估的性活动显著增加（P<0.001）以及性欲和勃起功能显著增加相关。在身体功能试验中，两个研究组之间6分钟步行距离增加至少50米的男性百分比没有显著差异，但当所有三项试验中的男性都包括在内时，差异确实显著（接受睾酮的男性为20.5%，接受安慰剂的男性为12.6%，P=0.003）。根据慢性病治疗疲劳量表的功能评估，睾酮对活力没有显着益处，但接受睾酮治疗的男性比接受安慰剂的男性情绪稍好，抑郁症状的严重程度较低。两组不良事件发生率相似。在65岁或以上的有症状男性中，将19至40岁男性的睾酮浓度从中等偏低提高到中等正常范围1年，对性功能有中度益处，对情绪和抑郁症状有一定益处，但对活力或步行距离没有益处。参与者的数量太少，无法得出关于睾酮治疗风险的结论。（由美国国立卫生研究院和其他机构资助; ClinicalTrials.gov编号，NCT 00799617。
Serum testosterone concentrations decrease as men age, but benefits of raising testosterone levels in older men have not been established. We assigned 790 men 65 years of age or older with a serum testosterone concentration of less than 275 ng per deciliter and symptoms suggesting hypoandrogenism to receive either testosterone gel or placebo gel for 1 year. Each man participated in one or more of three trials — the Sexual Function Trial, the Physical Function Trial, and the Vitality Trial. The primary outcome of each of the individual trials was also evaluated in all participants. Testosterone treatment increased serum testosterone levels to the mid-normal range for men 19 to 40 years of age. The increase in testosterone levels was associated with significantly increased sexual activity, as assessed by the Psychosexual Daily Questionnaire (P<0.001), as well as significantly increased sexual desire and erectile function. The percentage of men who had an increase of at least 50 m in the 6-minute walking distance did not differ significantly between the two study groups in the Physical Function Trial but did differ significantly when men in all three trials were included (20.5% of men who received testosterone vs. 12.6% of men who received placebo, P=0.003). Testosterone had no significant benefit with respect to vitality, as assessed by the Functional Assessment of Chronic Illness Therapy–Fatigue scale, but men who received testosterone reported slightly better mood and lower severity of depressive symptoms than those who received placebo. The rates of adverse events were similar in the two groups. In symptomatic men 65 years of age or older, raising testosterone concentrations for 1 year from moderately low to the mid-normal range for men 19 to 40 years of age had a moderate benefit with respect to sexual function and some benefit with respect to mood and depressive symptoms but no benefit with respect to vitality or walking distance. The number of participants was too few to draw conclusions about the risks of testosterone treatment. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00799617.)