Department of Experimental Medicine, Section of Medical Pathophysiology, Food Science and Endocrinology, Sapienza University of Rome, Rome, Italy.
Department of Clinical and Surgical Andrology, Center of Reproductive Medicine and Andrology, University of Münster, Münster, Germany.
J Endocrinol Invest. 2019 Dec;42(12):1491-1496. doi: 10.1007/s40618-019-01082-x. Epub 2019 Jul 2.
Testosterone replacement therapy (TRT) is recommended for the treatment of most cases of male hypogonadism. Transdermal testosterone (T) gels are commonly used in clinical practice; however, there is little evidence concerning how to monitor dosage to bring and maintain serum T levels in the normal physiologic range.
We examined 30 hypogonadal patients undergoing treatment with 40 mg/day transdermal 2% testosterone gel. After a week from treatment onset, all patients underwent a total of four measurements to assess serum total T, bioavailable T and free T at + 2 h (samples A and A') and + 23 h (samples B and B').
No significant difference was found concerning total, free and bioavailable T between the two samples taken at the same time points (A vs A' and B vs B'). A repeated-measures mixed effects regression model showed significantly lower serum levels of total, free and bioavailable T at + 23 h compared to + 2 h (total T, β = - 3.050 ± 0.704, p < 0.001; free T, β = - 85.187 ± 22.746, p < 0.001; bioavailable T, β = - 1.519 ± 0.497, p = 0.003) without a significant between-sample variability. Serum T > 3.5 ng/ml at + 2 h was reached in 21/30 patients (70%), but only 11 (36.7%) still had adequate serum T at + 23 h.
Assessment of TRT with transdermal gels at its peak and at its minimum could be useful in providing a finely tailored treatment for hypogonadal men, both preventing supra-physiological levels and maintaining adequate concentrations through the day.
睾酮替代疗法(TRT)被推荐用于大多数男性性腺功能减退症的治疗。透皮睾酮(T)凝胶在临床实践中常用;然而,关于如何监测剂量以使血清 T 水平维持在正常生理范围内,几乎没有证据。
我们检查了 30 名接受 40mg/天的透皮 2%睾酮凝胶治疗的性腺功能减退症患者。治疗开始后一周,所有患者总共进行了四次测量,以评估血清总 T、生物可利用 T 和游离 T 在 +2 小时(样本 A 和 A')和 +23 小时(样本 B 和 B')时的水平。
在同一时间点采集的两个样本(A 与 A'和 B 与 B')之间,总 T、游离 T 和生物可利用 T 无显著差异。重复测量混合效应回归模型显示,与 +2 小时相比,+23 小时时血清总 T、游离 T 和生物可利用 T 水平显著降低(总 T,β=-3.050±0.704,p<0.001;游离 T,β=-85.187±22.746,p<0.001;生物可利用 T,β=-1.519±0.497,p=0.003),但样本间无显著差异。21/30 名患者(70%)在 +2 小时时血清 T>3.5ng/ml,但只有 11 名患者(36.7%)在 +23 小时时仍有足够的血清 T。
在透皮凝胶的峰值和最低值时评估 TRT 可能有助于为性腺功能减退症男性提供精细调整的治疗,既可以防止超生理水平,又可以维持全天的适当浓度。