■使用庚酸睾酮(TE),50-75mg肌内(i.m.)/月,用于治疗青春期延迟或进展缓慢的男孩以诱导青春期是瑞典的标准护理(SoC)。这种治疗是经验性的,没有经过科学评估。瑞典性腺功能减退的男孩/年轻男性在诱导后的替代疗法主要是用睾酮十一烷酸酯(TU)进行的,1,000毫克/3个月。TE仅在许可证上可用。TE于2006年在瑞典注销。因此,这项研究是为了比较这两种产品。
■为了临床评估六次注射TE的青春期进展,75mgi.m./月(成人剂量的1/3-1/5),与两次注射TU相比,250mgi.m./3个月(成人剂量的1/4)。
■在男孩青春期置换研究(PRIBS)中,在一项平行研究中,西瑞典年龄14~16岁有青春期延迟的男孩被随机分配至TE或TU治疗青春期进展.纳入标准为早晨睾酮水平为0.5-3nmol/L,睾丸体积≤6ml。在2014年6月至2019年11月之间,包括27名男孩。
■主要结果是12个月后睾丸增大≥8ml。如果睾丸增大≥8ml的男孩数量为TE男孩数量的80%-125%,则认为TU治疗在临床上相似。Fisher精确卡方检验用于该分析。
■两种治疗均耐受良好。14名接受TU治疗的男孩中有12名(86%)达到了主要结局,TE组达到了12/12。Fisher的精确卡方检验表明单侧p值为0.28(双侧p值为0.483)。TU治疗被认为在临床上与SoC没有区别。一项事后研究显示25%的功率。因此,即使临床数据支持相似的治疗效果,也无法从结果中得出基于证据的结论.
■目前的小规模研究支持TE和TU在青春期进展方面具有相似的作用。
■https://www.clinicaltrials.gov/ct2/home,标识符NCT05417035;https://www.临床试验登记。eu/ctrsearch/search,标识符EUDRACTEudraCTnr2012-002337-11。
The use of testosterone enanthate (TE), 50-75 mg intramuscularly (i.m.)/month, for the treatment of boys with delayed puberty or slow progression to induce puberty is the standard of care (SoC) in Sweden. This treatment is empirical and has not been scientifically evaluated. Replacement therapy in hypogonadal boys/young men in Sweden after induction is mainly performed with testosterone undecanoate (TU), 1,000 mg/3 months. TE is only available on license. TE was deregistered in Sweden in 2006. Therefore, this
study was initiated to compare the two products.
To clinically evaluate pubertal progression with six injections of TE, 75 mg i.m./month (1/3-1/5 of adult dose), compared with two injections of TU, 250 mg i.m./3 months (1/4 of adult dose).
In the Pubertal Replacement in Boys
Study (PRIBS), boys aged 14-16 years in West Sweden with pubertal delay were randomized in a parallel
study to TE or TU for pubertal progression. Inclusion criteria were morning testosterone levels of 0.5-3 nmol/L and testicular volume ≤6 ml. Between June 2014 and Nov 2019, 27 boys were included.
The primary outcome was testicular enlargement ≥8 ml after 12 months. TU treatment was considered clinically similar if the number of boys with testicular enlargement ≥8 ml was 80%-125% of the number of boys with TE. Fisher\'s exact chi-square test was used for this analysis.
Both treatments were well tolerated. Twelve of 14 (86%) TU-treated boys reached the primary outcome and 12/12 in the TE group. Fisher\'s exact chi-square testing indicated a one-sided p-value of 0.28 (the two-sided p-value was 0.483). The TU treatment was considered not clinically different from SoC. A post-hoc
study showed 25% power. Therefore, no evidence-based conclusion can be drawn from the results even if the clinical data support a similar effect of the treatments.
The present small-scale
study supports that both TE and TU had similar effects in terms of pubertal progression.
https://www.clinicaltrials.gov/ct2/home, identifier NCT05417035; https://www.clinicaltrialsregister.eu/ctrsearch/search, identifier EUDRACTEudraCT nr 2012-002337-11.