Department of Clinical and Experimental Medicine, Section of Geriatrics, University of Parma, Italy Geriatric Rehabilitation Department, University Hospital of Parma, Parma, Italy.
Division of Endocrinology, Diabetes, and Metabolism, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
Endocr Pract. 2014 Nov;20(11):1170-7. doi: 10.4158/EP13357.OR.
During the male aging process, testosterone (T) levels progressively fall and inflammatory biomarkers increase. Although a relationship between these 2 phenomena has been tested in previous clinical trials, there is inconclusive evidence about the potential anti-inflammatory action of T.
A total of 108 healthy males >65 years with serum T concentration <475 ng/dL were recruited by direct mailings to alumni of the University of Pennsylvania and Temple University and randomized to 60-cm2 T or a placebo patch for 36 months. Ninety-six subjects completed the trial. Information and stored serum specimens from this trial were used to test the hypothesis of the inhibitory effect of T on inflammation. We evaluated 70 males (42 in the T group) who had banked specimens from multiple time points available for assays of T, C-reactive protein (CRP), tumor necrosis factor (TNF)-α, soluble TNF-α receptor-1 (TNFR1), interleukin-6 (IL-6), and soluble IL-6 receptors (sIL6r and sgp130).
The mean age ± SD at baseline was 71.8 ± 4.9 years. Testosterone replacement therapy for 36 months did not induce significant decreases in inflammatory markers. A trend toward a significant increase was observed in the placebo group for TNF-α (P = .03) and sgp130 (P = .01). Significant differences in estimated means of TNFR1 (but not other inflammatory markers), with lower levels in the T group, were observed at the 36-month time point. In T-treated subjects we found an almost significant treatment x time interaction term TNFR1 (P = .02) independent of total body fat content as assessed by dual energy X-ray absorptiometry (DXA). No serious adverse effect was observed.
Transdermal T treatment of older males for 36 months is not associated with significant changes in inflammatory markers.
在男性衰老过程中，睾丸激素（T）水平逐渐下降，炎症生物标志物增加。尽管以前的临床试验已经检验了这两种现象之间的关系，但 T 具有潜在抗炎作用的证据尚无定论。
通过直接邮寄给宾夕法尼亚大学和天普大学的校友，共招募了 108 名年龄在 65 岁以上且血清 T 浓度<475ng/dL 的健康男性，并将其随机分为 T 组或安慰剂贴片组，治疗 36 个月。96 名受试者完成了试验。本试验的信息和储存的血清标本用于检验 T 对炎症的抑制作用的假设。我们评估了 70 名男性（T 组 42 名），他们的银行标本可用于测定 T、C 反应蛋白（CRP）、肿瘤坏死因子（TNF）-α、可溶性 TNF-α受体-1（TNFR1）、白细胞介素-6（IL-6）和可溶性白细胞介素-6 受体（sIL6r 和 sgp130）。
基线时的平均年龄±SD 为 71.8±4.9 岁。36 个月的 T 替代治疗并未导致炎症标志物显著下降。安慰剂组 TNF-α（P=0.03）和 sgp130（P=0.01）的水平呈上升趋势。在 36 个月时，T 组 TNFR1（但其他炎症标志物没有）的估计均值差异具有统计学意义，水平较低。在 T 治疗的受试者中，我们发现 TNFR1 的治疗×时间交互项（P=0.02）具有统计学意义，与双能 X 射线吸收法（DXA）评估的全身脂肪含量无关。未观察到严重不良事件。
对老年男性进行为期 36 个月的经皮 T 治疗与炎症标志物的显著变化无关。
