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Long-Term Efficacy and Safety of Recombinant Human Growth Hormone in Children Born Small for Gestational Age

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单位: [1]Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [2]Endocrine and Genetics and Metabolism, Beijing Children's Hospital, Beijing, China. [3]Pediatrics, Jiangsu Provincial People's Hospital, Jiangsu, China. [4]Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China. [5]Medical Genetics and Endocrinology, Children's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Children's Hospital, Shanghai, China.
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关键词: growth disorder HT-SDS height velocity gestational age

摘要:
There is a lack of long-term data on the benefit of growth hormone (GH) treatment in Chinese children born small for gestational age (SGA). This study was conducted to assess the long-term efficacy and safety of GH treatment in children born SGA. One hundred and twenty prepubertal SGA children who did not achieve catch-up growth with height remained less than -2 standard deviations (SD) below gender-specific height were enrolled in this two-year, randomized, dose-comparative study followed by an extension study of up to 10 years. Daily subcutaneous injections of 0.23 mg/kg/week [low-dose (LD) group] or 0.46 mg/kg/week [high-dose (HD) group] somatropin were given for 104 weeks. Dosing in the extension study was≤0.46 mg/kg/week. The main outcome measures were change in height SD score (ΔHT-SDS), height velocity, insulin-like growth factor (IGF)-1, and IGF-1/IGF binding protein-3 (IGFBP-3) molar ratio. ΔHT-SDS at week 104 was 0.91±0.53 and 1.52±0.64 in the LD and HD groups (intergroup p<0.0001), respectively, and continued in an upward trend throughout the extension study, remaining above+2 for those who received treatment for a total of 7 years or more. At week 104, significant improvements were observed in height velocity, IGF-1 SDS, and IGF-1/IGFBP-3 molar ratio. Adult HT-SDS was -0.81±1.68 for boys and -0.82±1.05 for girls (p=0.9837). Glucose metabolism and thyroid function were within the normal reference range throughout treatment. Long-term recombinant human GH treatment was tolerable and effective at improving height in children born SGA.The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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出版当年[2022]版:
大类 | 4 区 医学
小类 | 4 区 内分泌学与代谢
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 内分泌学与代谢
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出版当年[2021]版:
Q4 ENDOCRINOLOGY & METABOLISM
最新[2023]版:
Q3 ENDOCRINOLOGY & METABOLISM

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第一作者单位: [1]Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
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通讯机构: [1]Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [*1]Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology Department of Pediatrics 1095 Jiefang Avenue, Wuhan, Hubei 430030 Wuhan China
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