特发性低促性腺激素性性腺功能减退男性中序贯与持续使用纯化尿促卵泡素/人绒毛膜促性腺激素的比较
Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism.
作者信息
Zhang Manna, Tong Guoyu, Liu Yanling, Mu Yiming, Weng Jianping, Xue Yaoming, Luo Zuojie, Xue Yuanming, Shi Lixin, Wu Xueyan, Sun Shouyue, Zhu Yanhua, Cao Ying, Zhang Jie, Huang Hong, Niu Ben, Li Hong, Guo Qinghua, Gao Yan, Li Zhibin, Ning Guang, Zhu Dalong, Li Xiaoying
机构信息
Shanghai Institute of Endocrinology and Metabolism (M.Z., Y.L., S.S., G.N., X.L.), Department of Endocrinology and Metabolism, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China 201101; Department of Endocrinology (G.T., H.H., D.Z.), Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China 210029; Department of Endocrinology (Y.M., Q.G., Y.G.), General Hospital of Chinese People's Liberation Army, Beijing, China 100037; Department of Endocrinology (J.W., Y.Z.), The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China 510630; Department of Endocrinology and Metabolism (Ya.X., Y.C.), Nanfang Hospital, Southern Medical University, Guangzhou, China 510515; Department of Endocrinology (Z.Luo, J.Z.), Guangxi Medical University and First Affiliated Hospital, Guangxi, China 530027; Department of Endocrinology (Yu.X., B.N.), The First People's Hospital of Yunnan Province, Yunnan, China 650091; Department of Endocrinology (L.S., H.L.), The Affiliated Hospital of Guiyang Medical College, Guizhou, China 550004; Department of Endocrinology (X.W.), Peking Union Medical College Hospital, Peking Union Medical College, Beijing, China 100730; and Epidemiology Research Unit (Z.Li), The First Affiliated Hospital, Xiamen University, Xiamen, China 361003.
出版信息
J Clin Endocrinol Metab. 2015 Jun;100(6):2449-55. doi: 10.1210/jc.2014-3802. Epub 2015 Mar 31.
CONTEXT
Gonadotropin therapy using a human chorionic 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
A total 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 × 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 × 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.
背景
使用人绒毛膜促性腺激素（hCG）和促卵泡激素（FSH）制剂进行促性腺激素治疗，是诱导特发性低促性腺激素性性腺功能减退（IHH）男性出现男性化和精子发生的有效方案。然而，药物成本高和频繁注射影响了依从性。
目的
本研究旨在确定序贯使用高纯度尿促卵泡素（uFSH）/hCG对IHH男性的疗效。
设计与地点
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。
患者与干预
共67名中国IHH男性被随机分为A组，接受持续uFSH（75 U，每周3次）和hCG（2000 U，每周2次）注射；B组接受序贯uFSH（75 U，每3个月每周3次）和hCG（2000 U，每周2次）注射。
主要观察指标
主要结局是在18个月期间精子浓度≥1.0×／mL的受试者比例。比较A组和B组之间的疗效是否具有非劣效性。
结果
在接受持续uFSH/hCG的患者中，17/33（51.5%）达到精子浓度≥1.0×／mL；在接受序贯uFSH/hCG的患者中，19/34（55.9%）达到该标准。根据意向性分析，序贯uFSH/hCG组的疗效不劣于持续uFSH/hCG组（非劣效性，P = 0.008）。
结论
在诱导IHH患者精子发生和男性化方面，序贯uFSH/hCG方案的疗效不劣于持续uFSH/hCG方案。
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