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Comparative evaluation of short-term biomarker response to treatment for growth hormone deficiency in Chinese children with growth hormone deficiency born small for or appropriate for gestational age: A randomized phase IV open-label study

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单位： [a]Ruijin Hospital, Jiaotong University School of Medicine, Shanghai, China [b]Children's Hospital of Fudan University, Shanghai, China [c]Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China [d]Beijing Children's Hospital, Capital Medical University, Beijing, China [e]Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China [f]Children's Hospital of Zhejiang University School of Medicine, Hangzhou, China [g]Sun Yat-sen University, Guangzhou, Beijing, China [h]Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China [i]Merck Serono China, Beijing, China

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关键词： biomarker response insulin-like growth factor I insulin-like growth factor-binding protein 3 recombinant human growth hormone

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To compare the response between Chinese children with growth hormone deficiency (GHD) born either small for gestational age (SGA) or appropriate for gestational age (AGA) after 4 weeks of recombinant human growth hormone (r-hGH) therapy. Methods: This was a phase IV, open-label, multicenter, interventional study (NCT01187550). Prepubertal children with GHD received open-label treatment with daily r-hGH (0.033 mg/kg) for 4 weeks. Serum levels of insulin-like growth factor I (IGF-I) and insulin-like growth factor-binding protein 3 (IGFBP3), and metabolic markers (including fasting glucose, insulin, total cholesterol, and homeostasis model assessment of insulin resistance) were assessed at baseline and after 4 weeks of treatment, and were analyzed according to patient subgroup (SGA or AGA). Results: A total of 205 children with GHD (mean age 10.4 years; 175 AGA, 30 SGA) were included in the analysis. Mean baseline serum IGF-I and IGFBP3 standard deviation scores (SDS) across the whole patient population were lower than the population norms (mean values: -2.1 SDS for IGF-I and -1.2 SDS for IGFBP3), with no significant differences between the two patient subgroups. After 4 weeks, IGF-I and IGFBP3 levels increased by 1.0 SDS (p < 0.001) and 0.34 SDS (p < 0.001), respectively, but no significant differences were found between the two patient subgroups for growth-related or metabolic markers. For children with GHD born SGA, IGF-I and IGFBP3 are short-term biomarkers of responsiveness to treatment with growth hormone, as for children with GHD born AGA. © 2013, SAGE Publications. All rights reserved.

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大类 | 3 区医学

小类 | 3 区内分泌学与代谢

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第一作者单位： [a]Ruijin Hospital, Jiaotong University School of Medicine, Shanghai, China

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通讯机构： [a]Ruijin Hospital, Jiaotong University School of Medicine, Shanghai, China [*1]Ruijin Hospital, Jiaotong University School of Medicine, No. 197, 2nd Ruijin Road, Shanghai, Shanghai City 200025, China

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Comparative evaluation of short-term biomarker response to treatment for growth hormone deficiency in Chinese children with growth hormone deficiency born small for or appropriate for gestational age: A randomized phase IV open-label study

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