Adverse events associated with testosterone administration.
Adverse events associated with testosterone administration.
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DOI：
10.1056/nejmoa1000485
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发表时间：
2010-07-08
期刊：
影响因子：
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通讯作者：
Bhasin S
中科院分区：
文献类型：
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作者：
Basaria S;Coviello AD;Travison TG;Storer TW;Farwell WR;Jette AM;Eder R;Tennstedt S;Ulloor J;Zhang A;Choong K;Lakshman KM;Mazer NA;Miciek R;Krasnoff J;Elmi A;Knapp PE;Brooks B;Appleman E;Aggarwal S;Bhasin G;Hede-Brierley L;Bhatia A;Collins L;LeBrasseur N;Fiore LD;Bhasin S
补充睾酮已被证明可以增加健康老年男性的肌肉质量和力量。睾酮治疗在行动受限的老年男性中的安全性和有效性尚未研究。社区居住的男性，65岁或以上，活动受限，血清总睾酮水平为100 - 350 ng/dl（3.5 - 12.1 nmol/L）或游离血清睾酮水平低于50 pg/ml（173 pmol/L），随机分配接受安慰剂凝胶或睾酮凝胶，每日应用6个月。使用国际医学用语词典分类对不良事件进行分类。数据和安全监测委员会建议提前终止试验，因为睾酮组的不良心血管事件发生率明显高于安慰剂组。试验终止时，共入组209例男性（平均年龄74岁）。基线时，参与者中高血压、糖尿病、高脂血症和肥胖的患病率较高。在研究过程中，睾酮组的心脏、呼吸和皮肤病事件发生率高于安慰剂组。睾酮组共有23名受试者发生心血管相关不良事件，而安慰剂组有5名。心血管相关不良事件的相对风险在整个6个月治疗期间保持恒定。与安慰剂组相比，睾酮组在腿部和胸部按压力量以及在负重时爬楼梯方面有显着更大的改善。在这一老年男性人群中，活动受限且慢性病患病率高，应用睾酮凝胶与心血管不良事件风险增加相关。试验规模小和独特的人群阻止了对睾酮治疗的安全性进行更广泛的推断。
Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied. Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group. A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load. In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.