Growth hormone treatment in pre-pubertal short Chinese children with chronic kidney disease prior to transplantation

作者全名："Tang, Xiaoshan; Chen, Qiuxia; Chen, Jing; Fang, Xiaoyan; Zhang, Aihua; Zhao, Fei; Huang, Wenyan; Wang, Ping; Sun, Liwen; Xiao, Huijie; Xu, Ke; Liu, Xiaorong; Chen, Zhi; Chen, Chaoying; Tu, Juan; Wu, Yubin; Wang, Xiuli; Mao, Jianhua; Lu, Zhihong; Wang, Jingjing; Nie, Xiaojing; Yu, Zihua; Huang, Jun; Liu, Cuihua; Cao, Guanghai; Li, Yufeng; Zhu, Yaju; Zhang, Jianjiang; Wang, Miao; Wang, Mo; Yang, Haiping; Shen, Qian; Xu, Hong"

作者地址："[Tang, Xiaoshan; Chen, Jing; Fang, Xiaoyan; Shen, Qian; Xu, Hong] Fudan Univ, Childrens Hosp, Shanghai Kidney Dev & Pediat Kidney Dis Res Ctr, Natl Childrens Med Ctr,Dept Nephrol, Shanghai, Peoples R China; [Chen, Qiuxia; Zhang, Aihua; Zhao, Fei] Nanjing Med Univ, Childrens Hosp, Dept Nephrol, Nanjing, Peoples R China; [Huang, Wenyan; Wang, Ping; Sun, Liwen] Shanghai Jiao Tong Univ, Childrens Hosp, Dept Nephrol & Rheumatol, Shanghai, Peoples R China; [Xiao, Huijie; Xu, Ke] Peking Univ First Hosp, Dept Pediat, Beijing, Peoples R China; [Liu, Xiaorong; Chen, Zhi] Capital Med Univ, Beijing Childrens Hosp, Dept Nephrol, Beijing, Peoples R China; [Chen, Chaoying; Tu, Juan] Capital Inst Pediat, Childrens Hosp, Dept Nephrol, Beijing, Peoples R China; [Wu, Yubin; Wang, Xiuli] China Med Univ, Shengjing Hosp, Dept Pediat, Shenyang, Peoples R China; [Mao, Jianhua; Lu, Zhihong; Wang, Jingjing] Zhejiang Univ, Childrens Hosp, Sch Med, Dept Nephrol, Binjiang Campus, Hangzhou, Peoples R China; [Nie, Xiaojing; Huang, Jun] 900th Hosp PLA, Dept Pediat, Fuzhou, Fujian, Peoples R China; [Yu, Zihua] Fujian Med Univ, Fuzhou Childrens Hosp, Dept Nephrol, Fuzhou, Fujian, Peoples R China; [Liu, Cuihua; Cao, Guanghai] Henan Childrens Hosp, Dept Nephrol & Rheumatol, Zhengzhou, Henan, Peoples R China; [Li, Yufeng; Zhu, Yaju] Shanghai Jiao Tong Univ, Xinhua Hosp, Sch Med, Dept Pediat Nephrol, Shanghai, Peoples R China; [Zhang, Jianjiang; Wang, Miao] Zhengzhou Univ, Affiliated Hosp 1, Dept Pediat, Zhengzhou, Peoples R China; [Wang, Mo; Yang, Haiping] Chongqing Med Univ, Affiliated Childrens Hosp, Dept Nephrol & Rheumatol, Chongqing, Peoples R China"

通信作者："Shen, Q; Xu, H (通讯作者)，Fudan Univ, Childrens Hosp, Shanghai Kidney Dev & Pediat Kidney Dis Res Ctr, Natl Childrens Med Ctr,Dept Nephrol, Shanghai, Peoples R China."

来源：PEDIATRIC RESEARCH

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000901718200001

JCR分区：Q1

影响因子：3.1

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

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摘要："BACKGROUND: The effect of recombinant human GH (rhGH) in Chinese children with chronic kidney disease (CKD) is unclear.METHODS: This was a 52-week, multicenter, randomized, open-label, negative-controlled phase 3 study. Prepubertal subjects were randomized 1:1 to either daily subcutaneous injections of rhGH 0.05 mg/kg/day or no treatment for 52 weeks. RESULTS: A total of 68 subjects with a mean age of 7.8 +/- 3.27 years were enrolled. At week 52, the height standard deviation score (HT-SDS) in the treated group increased by 0.75 +/- 0.58, which was significantly higher compared with 0.17 +/- 0.47 in the untreated group (least squares mean 0.58, 95% confidence interval, 0.32-0.84; P < 0.001). At week 52, significant improvements were observed in other growth parameters (height velocity [P < 0.001]), insulin-like growth factor 1 (IGF-1) SDS [P < 0.001], IFG-1/insulinlike growth factor binding protein-3 molar ratio [P < 0.001], and height [P < 0.001]) compared with the untreated control. Seven patients reported treatment-related adverse events (TRAEs) and most TRAEs were mild in severity. Most subjects recovered without further intervention.CONCLUSIONS: Daily rhGH for 52 weeks in children with CKD-induced growth retardation significantly improved HT-SDS and other growth parameters without compromising safety."

基金机构：GeneScience Pharmaceuticals

基金资助正文："This research was funded by GeneScience Pharmaceuticals. The funder was involvedin the design and conduct of the study; collection, management, analysis; review ofthe manuscript; and decision to submit the manuscript for publication."