Desai Sethi Urology Institute, University of Miami Miller School of Medicine, Miami, Florida.
Case Western Reserve University School of Medicine, Cleveland, Ohio.
J Urol. 2023 Jul;210(1):162-170. doi: 10.1097/JU.0000000000003487. Epub 2023 May 1.
Our primary aim was to compare changes in hematocrit in testosterone-deficient men treated with intranasal testosterone gel vs intramuscular testosterone cypionate.
This 2-arm, open-label, randomized trial recruited men with testosterone deficiency at the University of Miami between August 2020 and October 2022. Men with 2 total testosterone levels <350 ng/dL and hypogonadal symptoms, aged 18-75 years were randomly assigned to receive either intranasal testosterone gel 11 mg 3 times daily or intramuscular testosterone cypionate 200 mg every 2 weeks. The primary outcome was change in hematocrit after 4 months of treatment. Secondary outcomes were changes in serum testosterone, estradiol, prostate-specific antigen, 17-hydroxyprogesterone, and the 6-item International Index of Erectile Function.
Of the 81 men randomized, 54 completed treatment (intranasal n=23; intramuscular n=31). The mean age was 47.5 vs 49.5 years, with mean baseline testosterone of 244.6 vs 240.7 ng/dL and mean hematocrit of 44.4% vs 42.7% in intranasal vs intramuscular groups, respectively. Men who received intramuscular injections had a significant increase after 4 months of treatment in mean hematocrit from 42.7% to 46.6% (0001), but there was no significant change in men who received intranasal gel (233). Men in both groups experienced significantly increased serum testosterone levels throughout the study period, though a larger increase was seen in men treated with intramuscular injections (mean change 511 vs 283, 025). Men who received injections also experienced an increase in estradiol (mean change 22.9, 001), decrease in 17-hydroxyprogesterone (mean change -39.8, 0001), and increase in the 6-item International Index of Erectile Function score (mean change 4.8, 015); men treated with intranasal gel experienced no such changes. Prostate-specific antigen levels were stable in both groups.
Intranasal testosterone gel does not appear to significantly affect hematocrit levels. Men who wish to avoid polycythemia or changes in estradiol or 17-hydroxyprogesterone levels may benefit from short-acting testosterone therapy formulations such as intranasal gel.
我们的主要目的是比较接受经鼻睾酮凝胶与肌肉注射睾酮环戊丙酸酯治疗的睾酮缺乏男性的血细胞比容变化。
这项 2 臂、开放标签、随机试验于 2020 年 8 月至 2022 年 10 月在迈阿密大学招募了睾酮缺乏的男性。总睾酮水平 <350ng/dL 且有性腺功能减退症状、年龄在 18-75 岁的男性被随机分配接受经鼻睾酮凝胶 11mg，每日 3 次或肌肉注射睾酮环戊丙酸酯 200mg，每 2 周 1 次。主要结局是治疗 4 个月后血细胞比容的变化。次要结局是血清睾酮、雌二醇、前列腺特异性抗原、17-羟孕酮和 6 项国际勃起功能指数的变化。
在 81 名随机分组的男性中，54 名完成了治疗（经鼻组 n=23；肌肉组 n=31）。平均年龄分别为 47.5 岁和 49.5 岁，经鼻组和肌肉组的平均基线睾酮分别为 244.6ng/dL 和 240.7ng/dL，平均血细胞比容分别为 44.4%和 42.7%。接受肌肉注射的男性在治疗 4 个月后，血细胞比容从 42.7%显著增加至 46.6%（0001），而接受经鼻凝胶治疗的男性无显著变化（233）。两组男性在整个研究期间的血清睾酮水平均显著升高，尽管肌肉注射组的升高幅度更大（平均变化 511 比 283，025）。接受注射的男性还经历了雌二醇的增加（平均变化 22.9，001），17-羟孕酮的减少（平均变化-39.8，0001）和 6 项国际勃起功能指数评分的增加（平均变化 4.8，015）；接受经鼻凝胶治疗的男性则没有这种变化。前列腺特异性抗原水平在两组中均保持稳定。
经鼻睾酮凝胶似乎不会显著影响血细胞比容水平。希望避免红细胞增多症或雌二醇或 17-羟孕酮水平变化的男性可能受益于经鼻凝胶等短效睾酮治疗制剂。
