Amano Toshiyasu, Imao Tetsuya, Takemae Katsurou, Iwamoto Teruaki, Yamakawa Katsunori, Baba Katsuyuki, Nakanome Mariko, Sugimori Hiroki, Tanaka Toshiaki, Yoshida Katsumi, Katabami Takuyuki, Tanaka Masami
Department of Urology, Nagano Red Cross Hospital, Nagano, Japan.
J Sex Med. 2008 Jul;5(7):1727-36. doi: 10.1111/j.1743-6109.2007.00689.x.
Testosterone replacement therapy has been applied to alleviate the various symptoms of late-onset hypogonadism (LOH) patients. Several routes are available for the administration of testosterone to LOH patients, and transdermal delivery is an attractive method above all.
The aim of this article was to clarify the profile of serum total testosterone (TT) and free testosterone (FT) levels after application of testosterone ointment (Glowmin [GL], Daito Pharmaceutical Co. Ltd., Tokyo, Japan) and its clinical efficacy in LOH patients.
Serum TT and FT levels were examined in healthy male volunteers and LOH patients after application of 3 mg of GL. Then, 50 LOH patients received 3 mg of GL twice daily on scrotal skin (6 mg/day) for 12 weeks. Subsequently, TT and FT levels immediately prior to GL application were compared with those at 1 hour after GL treatment. Furthermore, the clinical effects of GL in the aforementioned 50 LOH patients were estimated after 12 weeks of GL treatment.
Hormonal effects of GL were evaluated by serum TT and FT levels. Aging males symptoms (AMS), international index of erectile function (IIEF-5), and MOS 36-item short form Healthy Survey (SF-36) questionnaire were used to assess the clinical efficacy of GL for LOH patients.
Maximum TT and FT values, which were detected 1-2 hours after application of a 2-cm line of GL (3 mg of testosterone) to scrotal skin, were not elevated beyond physiological levels; subsequently, these levels returned to circadian rhythm after 4 hours in four healthy male volunteers. The highest TT and FT levels were also obtained after 1-2 hours in four LOH patients involving identical administration methods; moreover, these levels were maintained within a normal range for 6 hours. After 12 weeks of GL treatment in 50 LOH patients, TT and FT levels demonstrated the same satisfactory response as that of the initial GL administration without GL accumulation effects. GL accumulation after 1 week in healthy men and after 12 weeks in LOH patients was not observed. Furthermore, AMS score decreased markedly; IIEF-5 and four domains of the SF-36 score were elevated significantly following GL application. Severe adverse reactions were not observed.
Accordingly, GL, which is a short-acting testosterone ointment eliciting physiological elevation of TT and FT, appears to be suitable for LOH treatment.
睾酮替代疗法已被用于缓解迟发性性腺功能减退（LOH）患者的各种症状。向LOH患者给药睾酮有多种途径，其中经皮给药是最具吸引力的方法。
本文旨在阐明应用睾酮软膏（Glowmin [GL]，日本东京大制药株式会社）后血清总睾酮（TT）和游离睾酮（FT）水平的变化情况及其对LOH患者的临床疗效。
对健康男性志愿者和LOH患者涂抹3mg GL后检测血清TT和FT水平。然后，50例LOH患者在阴囊皮肤处每日两次涂抹3mg GL（6mg/天），持续12周。随后，将涂抹GL前即刻的TT和FT水平与GL治疗1小时后的水平进行比较。此外，在GL治疗12周后评估GL对上述50例LOH患者的临床效果。
通过血清TT和FT水平评估GL的激素效应。采用老年男性症状（AMS）、国际勃起功能指数（IIEF - 5）和MOS 36项简短健康调查（SF - 36）问卷评估GL对LOH患者的临床疗效。
在阴囊皮肤涂抹2cm长的GL（3mg睾酮）后1 - 2小时检测到的TT和FT最大值未超过生理水平；随后，在4名健康男性志愿者中，这些水平在4小时后恢复昼夜节律。在4例采用相同给药方法的LOH患者中，1 - 2小时后也获得了最高的TT和FT水平；此外，这些水平在6小时内维持在正常范围内。50例LOH患者经GL治疗12周后，TT和FT水平显示出与初次涂抹GL时相同的满意反应，且无GL蓄积效应。未观察到健康男性1周后及LOH患者12周后的GL蓄积情况。此外，AMS评分显著降低；涂抹GL后IIEF - 5及SF - 36评分的四个领域均显著升高。未观察到严重不良反应。
因此，GL作为一种能使TT和FT生理性升高的短效睾酮软膏，似乎适用于LOH的治疗。
