The efficacy and safety of highly purified follicle stimulating hormone (FSH) associated with human chorionic gonadotrophin (HCG) was studied in 60 men with hypogonadotrophic hypogonadism. Of these men, 16 suffered from Kallmann's syndrome, 19 from idiopathic hypogonadotrophic hypogonadism and 25 from hypopituitarism. Basal testosterone concentrations were found to be far below the normal range. At baseline, 26 patients were able to ejaculate and all of them showed azoospermia, while the remaining patients were aspermic. All patients self-administered s.c. injections of FSH (150 IU x three/week) and HCG (2500 IU x two/week) for at least 6 months and underwent periodic assessments of testicular function. Testosterone concentrations increased rapidly during treatment and all but one patient reached normal values. Testicular volume showed a sustained increase reaching almost 3-fold its baseline value. At the end of treatment, 48 patients (80.0%) had achieved a positive sperm count. The maximum sperm concentration during treatment was 24.5 +/- 8.1 x 10(6)/ml (mean +/- SEM). The median time to induce spermatogenesis was 5 months. Eleven patients reported adverse events, generally not related to treatment. Three patients experienced gynaecomastia. No local reactions at injection site were observed. In conclusion, the s.c. self-administration of highly purified FSH + HCG was well tolerated and effective in stimulating spermatogenesis and steroidogenesis in these patients.

译文

在60名患有促性腺激素缺乏性性腺功能减退症的男性中研究了与人绒毛膜促性腺激素(HCG)相关的高纯度卵泡刺激素(FSH)的疗效和安全性。在这些男性中,有16名患有卡曼综合症,19名患有特发性性腺功能减退性腺功能减退症,25名患有垂体功能减退症。发现基础睾丸激素浓度远低于正常范围。在基线时,有26位患者能够射精,所有患者均表现出无精子症,而其余患者均为无精子症。所有患者均自给自足注射FSH(150 IU x 3 /周)和HCG(2500 IU x 2 /周)至少6个月,并定期评估睾丸功能。治疗期间睾丸激素浓度迅速增加,除一名患者外,其他所有患者均达到正常值。睾丸体积持续增加,几乎达到其基线值的三倍。在治疗结束时,有48位患者(80.0%)的精子计数为阳性。治疗期间最大精子浓度为24.5 /-8.1 x 10(6)/ ml(平均值/-SEM)。诱导精子发生的中位时间为5个月。 11名患者报告了不良事件,通常与治疗无关。三例患者出现了妇科发育不全。在注射部位未观察到局部反应。总而言之自我给予高纯度FSH HCG的耐受性良好,可有效刺激这些患者的精子发生和类固醇生成。

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