人绒毛膜促性腺激素联合人绝经期促性腺激素和促性腺激素释放激素泵治疗先天性低促性腺激素性性腺功能减退症男性青少年的疗效和安全性。

Efficacy and safety of human chorionic gonadotropin combined with human menopausal gonadotropin and a gonadotropin-releasing hormone pump for male adolescents with congenital hypogonadotropic hypogonadism.

机构信息

Department of Pharmacy, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China.

Department of Endocrinology, Genetics and Metabolism, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China.

出版信息

Chin Med J (Engl). 2021 Mar 31;134(10):1152-1159. doi: 10.1097/CM9.0000000000001419.

DOI:10.1097/CM9.0000000000001419

PMID:33813517

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8143779/

Abstract

BACKGROUND

Compared to adult studies, studies which involve the treatment of pediatric congenital hypogonadotropic hypogonadism (CHH) are limited and no universal treatment regimen is available. The aim of this study was to evaluate the feasibility of human chorionic gonadotropin (hCG)/human menopausal gonadotropin (hMG) therapy for treating male adolescents with CHH.

METHODS

Male adolescent CHH patients were treated with hCG/hMG (n = 20) or a gonadotropin-releasing hormone (GnRH) pump (n = 21). The treatment was divided into a study phase (0-3 months) and a follow-up phase (3-12 months). The testicular volume (TV), penile length (PL), penis diameter (PD), and sex hormone levels were compared between the two groups. The TV and other indicators between the groups were analyzed using a t-test (equal variance) or a rank sum test (unequal variance).

RESULTS

Before treatment, there was no statistical difference between the two groups in terms of the biochemistry, hormones, and other demographic indicators. After 3 months of treatment, the TV of the hCG/hMG and GnRH groups increased to 5.1 ± 2.3 mL and 4.1 ± 1.8 mL, respectively; however, the difference was not statistically significant (P > 0.05, t = 1.394). The PL reached 6.9 ± 1.8 cm and 5.1 ± 1.6 cm (P < 0.05, t = 3.083), the PD reached 2.4 ± 0.5 cm and 2.0 ± 0.6 cm (P < 0.05, t = 2.224), respectively, in the two groups. At the end of 6 months of treatment, biomarkers were in normal range in the two groups. Compared with the GnRH group, the testosterone (T) level and growth of PL and PD were significantly greater in the hCG/hMG group (all P < 0.05). While the TV of both groups increased, the difference was not statistically significant (P > 0.05, t = 0.314). After 9 to 12 months of treatment, the T level was higher in the hCG/hMG group. Other parameters did not exhibit a statistical difference.

CONCLUSIONS

The hCG/hMG regimen is feasible and effective for treating male adolescents with CHH. The initial 3 months of treatment may be a window to optimally observe the strongest effects of therapy. Furthermore, results from the extended time-period showed positive outcomes at the 1-year mark; however, the long-term effectiveness, strengths, and weaknesses of the hCG/hMG regimen require further research.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02880280; https://clinicaltrials.gov/ct2/show/NCT02880280.

摘要

背景

与成人研究相比，涉及儿科先天性低促性腺激素性性腺功能减退症（CHH）治疗的研究有限，尚无通用的治疗方案。本研究旨在评估人绒毛膜促性腺激素（hCG）/人绝经期促性腺激素（hMG）治疗男性青少年 CHH 的可行性。

方法

采用 hCG/hMG（n=20）或促性腺激素释放激素（GnRH）泵（n=21）治疗男性青少年 CHH 患者。治疗分为研究阶段（0-3 个月）和随访阶段（3-12 个月）。比较两组患者的睾丸体积（TV）、阴茎长度（PL）、阴茎直径（PD）和性激素水平。两组间 TV 等指标的比较采用 t 检验（等方差）或秩和检验（不等方差）。

结果

治疗前，两组患者的生化、激素等人口统计学指标无统计学差异。治疗 3 个月后，hCG/hMG 组和 GnRH 组的 TV 分别增加至 5.1±2.3ml 和 4.1±1.8ml，但差异无统计学意义（P>0.05，t=1.394）。PL 分别达到 6.9±1.8cm 和 5.1±1.6cm（P<0.05，t=3.083），PD 分别达到 2.4±0.5cm 和 2.0±0.6cm（P<0.05，t=2.224）。两组治疗 6 个月时，生物标志物均在正常范围内。与 GnRH 组相比，hCG/hMG 组的睾酮（T）水平以及 PL 和 PD 的生长均显著更大（均 P<0.05）。两组 TV 均增加，但差异无统计学意义（P>0.05，t=0.314）。治疗 9-12 个月后，hCG/hMG 组 T 水平较高。其他参数无统计学差异。