Spona J, Gleispach H, Happ J, Kollmann F, Torresani T, von der Ohe M
Endocrinol Exp. 1979;13(4):201-7.
The aim of the present investigation was to study, in a collaborative double-blind study, the treatment with intranasal LH-RH application of boys aged 1 1/2 to 12 years, who suffered from unilateral or bilateral cryptorchidism. A total of 88 subjects were randomly and blindly allocated to LH-RH and placebo therapy. Before and after 4 weeks of treatment basal testosterone serum levels were estimated and LH-RH tests were performed. Intranasal treatment with LH-RH resulted in partial or complete descents of testes in 23 out of 88 patients, whereas the position of testes remained unchanged in 17 subjects. 42 boys did not respond to placebo therapy, but complete descents were observed in 6 boys of the placebo group. Hormone analysis data of 4 different laboratories were recorded and statistically evaluated. No changes of LH, FSH and testosterone were found in the placebo groups. Only patients of the Frankfurt group responded to LH-RH test with augmented LH release after therapy (P less than 0.05). All patients treated with intranasal LH-RH showed a significant decrease of FSH release after therapy (P less than 0.05 to P less than 0.01). Basal testosterone serum levels were found to be increased after therapy only in the patients treated at Zürich (P less than 0.05). Data of the present study combine to suggest that chronic application of LH-RH may result in an overstimulation phenomenon, and that LH-RH test as well as basal testosterone levels cannot be used as prognostic index of therapy efficacy.
本研究的目的是在一项合作双盲研究中,对1岁半至12岁患有单侧或双侧隐睾症的男孩进行鼻内应用促黄体生成素释放激素(LH-RH)的治疗研究。总共88名受试者被随机且盲法分配接受LH-RH治疗和安慰剂治疗。在治疗4周前后,测定血清基础睾酮水平并进行LH-RH试验。鼻内应用LH-RH治疗使88例患者中的23例睾丸部分或完全下降,而17例患者的睾丸位置未变。42名男孩对安慰剂治疗无反应,但在安慰剂组的6名男孩中观察到睾丸完全下降。记录了4个不同实验室的激素分析数据并进行统计学评估。安慰剂组中促黄体生成素(LH)、促卵泡生成素(FSH)和睾酮无变化。只有法兰克福组的患者在治疗后对LH-RH试验有LH释放增加的反应(P<0.05)。所有接受鼻内LH-RH治疗的患者在治疗后FSH释放均显著下降(P<0.05至P<0.01)。仅在苏黎世治疗的患者中,治疗后血清基础睾酮水平升高(P<0.05)。本研究数据综合表明,长期应用LH-RH可能导致过度刺激现象,且LH-RH试验以及基础睾酮水平不能用作治疗疗效的预后指标。