Efficacy of changing testosterone gel preparations (Androgel or Testim) among suboptimally responsive hypogonadal men
Efficacy of changing testosterone gel preparations (Androgel or Testim) among suboptimally responsive hypogonadal men
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DOI：
10.1038/sj.ijir.3901618
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发表时间：
2008-03-01
影响因子：
2.6
通讯作者：
Lipshultz, L. I.
中科院分区：
文献类型：
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作者：
Grober, E. D.;Khera, M.;Lipshultz, L. I.
该研究的目的是评估性腺机能减退男性中改变睾酮凝胶制剂的效果。对所有接受凝胶（Testim 或 Androgel）睾酮替代疗法 (TRT) 的性腺功能减退男性的记录进行审查，以确定因初始反应欠佳而接受凝胶 TRT 品牌替代的男性。比较凝胶替代前后的总和游离血清睾酮水平以及性腺功能减退症状 (ADAM) 的存在。在 370 名接受睾酮凝胶替代疗法的性腺功能减退男性中，75 名 (20%) 接受了品牌替代。在替代之前，最初接受Androgel治疗的患者中，平均总睾酮和游离睾酮水平分别为311 ng dl(-1) 和10.4 pg ml(-1)。 58% 的患者总睾酮水平低于 300 ng dl(-1)。改用Testim后，平均总睾酮和游离睾酮水平分别增加至484 ng dl(-1) (P < 0.001) 和14.6 pg ml(-1) (P = 0.01)。其中只有 17% 的患者总睾酮水平保持在 300 ng dl(-1) 以下。在最初接受Testim治疗的患者中，平均总睾酮和游离睾酮水平分别为544 ng dl(-1)和18.0 pg ml(-1)。 15% 的男性总睾酮水平低于 300 ng dl(-1)。将睾酮凝胶更换为Androgel后，平均总睾酮和游离睾酮水平分别为522 ng dl(-1) (P = 0.7) 和16.1 pg ml(-1) (P = 0.6)。其中 27% 的患者总睾酮水平仍低于 300 ng dl(-1)。在最初的生化或症状反应不佳后接受品牌替代的男性中，很大一部分性腺功能减退症状得到改善。在放弃或考虑更具侵入性的 TRT 之前，对最初无反应的性腺功能减退男性改变睾酮凝胶制剂是合理的。从 Androgel 改为 Testim 为性腺功能减退男性提供了改善临床和生化反应能力的潜力。从 Testim 改为 Androgel 可以消除或最大限度地减少不需要的副作用。
The study objective was to evaluate the efficacy of changing testosterone gel preparations among suboptimally responsive hypogonadal men. The records of all hypogonadal men on gel (Testim or Androgel) testosterone replacement therapy (TRT) were reviewed to identify men who underwent a brand substitution in gel TRT due to initial suboptimal response. Total and free serum testosterone levels and the presence of hypogonadal symptoms (ADAM) were compared pre- and post-gel substitution. Of the 370 hypogonadal men on testosterone gel replacement therapy, 75 (20%) underwent a brand substitution. Prior to substitution, among patients initially treated with Androgel, the mean total and free testosterone levels were 311 ng dl(-1) and 10.4 pg ml(-1), respectively. Total testosterone levels were below 300 ng dl(-1) in 58% of these patients. Following a change to Testim, mean total and free testosterone levels increased to 484 ng dl(-1) (P < 0.001) and 14.6 pg ml(-1) (P = 0.01), respectively. Total testosterone levels remained below 300 ng dl(-1) in only 17% of these patients. Among patients initially treated with Testim, the mean total and free testosterone levels were 544 ng dl(-1) and 18.0 pg ml(-1), respectively. Total testosterone levels were below 300 ng dl(-1) in 15% of men. Following testosterone gel change to Androgel, mean total and free testosterone levels were 522 ng dl(-1) (P = 0.7) and 16.1 pg ml(-1) (P = 0.6), respectively. Total testosterone levels remained below 300 ng dl(-1) in 27% of these patients. Hypogonadal symptoms improved in a significant proportion of men who underwent a brand substitution following an initial suboptimal biochemical or symptomatic response. A change in testosterone gel preparation among initially unresponsive hypogonadal men is justified prior to abandoning or considering more invasive TRT. Changing from Androgel to Testim offers hypogonadal men the potential for improved clinical and biochemical responsiveness. Changing from Testim to Androgel is indicated to eliminate or minimize unwanted side effects.