Behre H M, von Eckardstein S, Kliesch S, Nieschlag E
Institute of Reproductive Medicine of the University (WHO Collaborating Centre for Research in Human Reproduction), Münster, Germany.
Clin Endocrinol (Oxf). 1999 May;50(5):629-35. doi: 10.1046/j.1365-2265.1999.00705.x.
Testosterone (T) substitution of hypogonadal men by conventional intramuscular injection of T esters is not considered optimal because it induces unphysiologically fluctuating serum T levels. In contrast, scrotal T patches produce normal serum (T) levels mimicking diurnal variations. In order to assess the quality of this new form of T substitution we followed hypogonadal men treated by transdermal T up to 10 years.
Eleven men aged 35.9 +/- 9.8 years (mean +/- SD) at the beginning of the study were treated with transscrotal T patches (Testoderm) because of primary (n = 4) or secondary (n = 7) hypogonadism. Clinical examinations were performed every 3 months during the first 5 years and every 6 months thereafter. All 11 patients were seen for 7 years and some for longer periods: eight for 8 years, six for 9 years and four for 10 years.
With daily application of one patch T levels rose from 5.3 +/- 1.3 nmol/l (mean +/- SE) to 16.7 +/- 2.6 nmol/l at month 3 and remained in the normal range throughout treatment. Serum 5 alpha-dihydrotestosterone (DHT) rose from 1.3 +/- 0.4 nmol/l to 3.9 +/- 1.4 nmol/l and oestradiol from 52.3 +/- 9.3 to 71.3 +/- 9.6 pmol/l and remained stable without significant variations throughout the observation period. Patients reported absence of local side-effects except for occasional itching. No relevant changes occurred in clinical chemistry, including total cholesterol levels and triglycerides. Haemoglobin and erythrocyte counts remained normal. Bone density measured by QCT increased slightly from 113.6 +/- 5.4 to 129.7 +/- 9.3 mg/cm3 during the observation period (P = 0.028). In the nine patients aged < 50 years prostate volumes showed a small but insignificant increase from 16.8 +/- 1.5 to 18.8 +/- 2.1 ml during transscrotal T therapy. In the two older patients prostate volume remained constant or decreased slightly during T therapy after an initial increase in the previously untreated patient. Prostate specific antigen levels were constantly low in all patients.
Transscrotal testosterone patches are well-accepted and safe in long-term testosterone substitution therapy for male hypogonadism.
采用传统的肌内注射睾酮酯对性腺功能减退男性进行睾酮（T）替代治疗并不被认为是最佳方法，因为它会导致血清T水平出现非生理性波动。相比之下，阴囊T贴片可产生模仿昼夜变化的正常血清T水平。为了评估这种新型T替代治疗方式的质量，我们对接受经皮T治疗长达10年的性腺功能减退男性进行了随访。
研究开始时，11名年龄为35.9±9.8岁（均值±标准差）的男性因原发性（n = 4）或继发性（n = 7）性腺功能减退接受了经阴囊T贴片（Testoderm）治疗。在最初5年中每3个月进行一次临床检查，此后每6个月进行一次。所有11名患者均接受了7年的观察，部分患者观察时间更长：8名患者观察了8年，6名患者观察了9年，4名患者观察了10年。
每天使用一片贴片，T水平在第3个月时从5.3±1.3 nmol/l（均值±标准误）升至16.7±2.6 nmol/l，并在整个治疗过程中保持在正常范围内。血清5α - 双氢睾酮（DHT）从1.3±0.4 nmol/l升至3.9±1.4 nmol/l，雌二醇从52.3±9.3升至71.3±9.6 pmol/l，且在整个观察期内保持稳定，无显著变化。患者报告除偶尔瘙痒外无局部副作用。临床化学指标，包括总胆固醇水平和甘油三酯，无相关变化。血红蛋白和红细胞计数保持正常。在观察期内，通过定量CT测量的骨密度从113.6±5.4略微升至129.7±9.3 mg/cm³（P = 0.028）。在9名年龄<50岁的患者中，经阴囊T治疗期间前列腺体积从16.8±1.5略微增加至18.8±2.1 ml，但差异无统计学意义。在两名年龄较大的患者中，在T治疗期间，先前未治疗患者的前列腺体积最初增加后保持恒定或略有下降。所有患者的前列腺特异性抗原水平持续较低。
经阴囊睾酮贴片在男性性腺功能减退的长期睾酮替代治疗中被广泛接受且安全。
