Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism
Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism
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DOI：
10.1210/jc.2014-3802
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发表时间：
2015-06-01
影响因子：
5.8
通讯作者：
Li, Xiaoying
中科院分区：
文献类型：
--
作者：
Zhang, Manna;Tong, Guoyu;Li, Xiaoying
背景：使用人绒毛膜促性腺激素（hCG）和FSH制剂的促性腺激素治疗是特发性促性腺功能低下（IHH）男性诱导男性化和精子发生的有效方案。然而，高昂的药物费用和频繁的注射影响了依从性。目的：本研究的目的是确定顺序使用高纯度尿促卵泡刺激素(uFSH)/促绒毛膜促性腺激素（hCG）对IHH男性的疗效。设计和环境：在9家三级医院进行了一项随机、开放标签、前瞻性、对照非劣效性试验，随访18个月。患者及干预措施：67例中国男性IHH患者随机分为连续注射uFSH （75 U，每周3次）和hCG （2000 U，每周2次）的A组和连续注射uFSH （75 U，每周3次，每隔3个月）和hCG （2000 U，每周2次）的B组。主要结局指标：主要结局指标为18个月内精子浓度>= 1.0 × 10(6)/mL的受试者比例。A组和B组的疗效进行非劣效性比较。结果：连续接受uFSH/hCG治疗的患者中，17/33（51.5%）和连续接受uFSH/hCG治疗的患者中，19/34（55.9%）的精子浓度达到了>= 1.0 × 10(6)/mL。意向治疗分析显示，连续uFSH/hCG组的疗效不逊于连续uFSH/hCG组（非劣效性，P = 0.008）。结论：连续uFSH/hCG方案在诱导IHH患者精子发生和男性化方面的效果并不亚于连续uFSH/hCG方案。
Context: Gonadotropin therapy using ahumanchorionic gonadotropin (hCG) and FSH preparation is an effective regimen in inducing masculinization and spermatogenesis in men with idiopathic hypogonadotropic hypogonadism (IHH). However, the high cost of medication and frequent injections affect compliance.Objective: The aim of this study was to determine the efficacy of sequential use of highly purified urinary FSH (uFSH)/hCG in men with IHH.Design and Setting: A randomized, open-label, prospective, controlled noninferiority trial with an 18-month follow-up was conducted in 9 tertiary hospitals.Patients and Intervention: Atotal of 67 Chinese men with IHH were randomly allocated into group A receiving continual uFSH (75 U, 3 times a week) and hCG (2000 U, twice a week) injection and group B receiving sequential uFSH (75 U, 3 times a week every other 3 months) and hCG (2000 U, twice a week) injection.Main Outcome Measure: The primary outcome was the proportion of subjects with a sperm concentration of >= 1.0 x 10(6)/mL during the 18 months. The efficacy between groups A and B was compared for noninferiority.Results: Of the patients, 17/33 (51.5%) receiving continual uFSH/hCG and 19/34 (55.9%) receiving sequential uFSH/hCG achieved sperm concentrations of >= 1.0 x 10(6)/mL. The efficacy in the sequential uFSH/hCG group was not inferior to that in the continual uFSH/hCG group (noninferiority, P =.008) by intention-to-treat analysis.Conclusions: The efficacy of the sequential uFSH/hCG regimen is not inferior to that of the continual uFSH/hCG regimen in inducing spermatogenesis and masculinization of patients with IHH.