Section of Vascular Medicine, Division of Cardiovascular Disease, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.
Division of Biostatistics, Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.
J Clin Endocrinol Metab. 2018 Feb 1;103(2):681-688. doi: 10.1210/jc.2017-02243.
Studies of the possible cardiovascular risk of testosterone treatment are inconclusive.
To determine the effect of testosterone treatment on cardiovascular biomarkers in older men with low testosterone.
Double-blind, placebo-controlled trial.
Twelve academic medical centers in the United States.
In all, 788 men ≥65 years old with an average of two serum testosterone levels <275 ng/dL who were enrolled in The Testosterone Trials.
Testosterone gel, the dose adjusted to maintain the testosterone level in the normal range for young men, or placebo gel for 12 months.
Serum markers of cardiovascular risk, including lipids and markers of glucose metabolism, fibrinolysis, inflammation, and myocardial damage.
Compared with placebo, testosterone treatment significantly decreased total cholesterol (adjusted mean difference, -6.1 mg/dL; P < 0.001), high-density lipoprotein cholesterol (adjusted mean difference, -2.0 mg/dL; P < 0.001), and low-density lipoprotein cholesterol (adjusted mean difference, -2.3 mg/dL; P = 0.051) from baseline to month 12. Testosterone also slightly but significantly decreased fasting insulin (adjusted mean difference, -1.7 µIU/mL; P = 0.02) and homeostatic model assessment‒insulin resistance (adjusted mean difference, -0.6; P = 0.03). Testosterone did not change triglycerides, d-dimer, C-reactive protein, interleukin 6, troponin, glucose, or hemoglobin A1c levels more than placebo.
Testosterone treatment of 1 year in older men with low testosterone was associated with small reductions in cholesterol and insulin but not with other glucose markers, markers of inflammation or fibrinolysis, or troponin. The clinical importance of these findings is unclear and requires a larger trial of clinical outcomes.
关于睾酮治疗潜在心血管风险的研究尚无定论。
确定睾酮治疗对低睾酮老年男性心血管生物标志物的影响。
双盲、安慰剂对照试验。
美国 12 家学术医疗中心。
共纳入 788 名年龄在 65 岁以上、平均 2 次血清睾酮水平<275ng/dL 的男性，他们均参加了睾酮试验。
睾酮凝胶，剂量调整以维持年轻男性的正常睾酮水平，或安慰剂凝胶治疗 12 个月。
心血管风险的血清标志物，包括脂质和葡萄糖代谢、纤溶、炎症和心肌损伤的标志物。
与安慰剂相比，睾酮治疗从基线到第 12 个月时显著降低了总胆固醇（调整平均差异，-6.1mg/dL；P<0.001）、高密度脂蛋白胆固醇（调整平均差异，-2.0mg/dL；P<0.001）和低密度脂蛋白胆固醇（调整平均差异，-2.3mg/dL；P=0.051）。睾酮也略微但显著降低了空腹胰岛素（调整平均差异，-1.7µIU/mL；P=0.02）和稳态模型评估胰岛素抵抗（调整平均差异，-0.6；P=0.03）。与安慰剂相比，睾酮并未使甘油三酯、D-二聚体、C 反应蛋白、白细胞介素 6、肌钙蛋白、葡萄糖或糖化血红蛋白水平发生变化。
1 年的睾酮治疗对低睾酮老年男性，可使胆固醇和胰岛素水平略有降低，但不会改变其他葡萄糖标志物、炎症或纤溶标志物或肌钙蛋白水平。这些发现的临床重要性尚不清楚，需要更大规模的临床试验来评估临床结局。
