Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study
Objective: Polyethylene glycol recombinant human growth hormone (PEG-rhGH, Jintrolong®) is the first long-acting rhGH preparation that is approved to treat children with growth hormone deficiency (GHD) in China. Clinical experience with dose selections of PEG-rhGH is scarce. The present study compar...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-08-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.955809/full |
| _version_ | 1828149659492679680 |
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| author | Zhouhong Jiang Xuefeng Chen Guanping Dong Yin Lou Jianping Zhang Xinran Cheng Jiayan Pan Wei Liao Jinzhun Wu Xiaodong Huang Xianjiang Jin Deyun Liu Ting Zeng Shunye Zhu Qin Dong Xiaoming Luo Dan Lan Lizhi Cao Xingxing Zhang Jing Liu Mingjuan Dai Manyan Zhang Li Liu Junhua Dong Dongmei Zhao Shaoqing Ni Shaoqing Ni Junfen Fu Junfen Fu |
| author_facet | Zhouhong Jiang Xuefeng Chen Guanping Dong Yin Lou Jianping Zhang Xinran Cheng Jiayan Pan Wei Liao Jinzhun Wu Xiaodong Huang Xianjiang Jin Deyun Liu Ting Zeng Shunye Zhu Qin Dong Xiaoming Luo Dan Lan Lizhi Cao Xingxing Zhang Jing Liu Mingjuan Dai Manyan Zhang Li Liu Junhua Dong Dongmei Zhao Shaoqing Ni Shaoqing Ni Junfen Fu Junfen Fu |
| author_sort | Zhouhong Jiang |
| collection | DOAJ |
| description | Objective: Polyethylene glycol recombinant human growth hormone (PEG-rhGH, Jintrolong®) is the first long-acting rhGH preparation that is approved to treat children with growth hormone deficiency (GHD) in China. Clinical experience with dose selections of PEG-rhGH is scarce. The present study compared the efficacy and safety of a lower dose to increase dosing regimens of PEG-rhGH treatment.Methods: A multicenter, randomized, open-label, dose-comparison clinical study was conducted to compare the improvements in the height standard deviation score (Ht SDS), height velocity (HV), insulin-like growth factor-1 (IGF-1) SDS, and safety profiles of children with GHD who are treated with 0.2 mg/kg/week of PEG-rhGH dose or 0.14 mg/kg/week for 26 weeks.Results: Ht SDS, HV, and IGF-1 SDS increased significantly after PEG-rhGH treatment in the two dose groups (p < 0.05). The improvements of Ht SDS, HV, and IGF-1 SDS were more significant in the high-dose group than in the low-dose group (p < 0.05). Ht SDS improvement in low-dose group was not non-inferiority to that in the high-dose group (p = 0.2987). The incidences of adverse events were comparable between the two groups.Conclusion: The improvements of Ht SDS, HV, and IGF-1 SDS were more significant in the high-dose group than in the low-dose group (p < 0.05). PEG-rhGH at the dose of 0.14 mg/kg/week was effective and safe for children with GHD.Clinical Trial Registration:clinicaltrials.gov, identifier NCT02908958. |
| first_indexed | 2024-04-11T21:33:30Z |
| format | Article |
| id | doaj.art-e9823f9784f543bc88d9bf8455288e57 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-11T21:33:30Z |
| publishDate | 2022-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-e9823f9784f543bc88d9bf8455288e572022-12-22T04:01:53ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-08-011310.3389/fphar.2022.955809955809Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison studyZhouhong Jiang0Xuefeng Chen1Guanping Dong2Yin Lou3Jianping Zhang4Xinran Cheng5Jiayan Pan6Wei Liao7Jinzhun Wu8Xiaodong Huang9Xianjiang Jin10Deyun Liu11Ting Zeng12Shunye Zhu13Qin Dong14Xiaoming Luo15Dan Lan16Lizhi Cao17Xingxing Zhang18Jing Liu19Mingjuan Dai20Manyan Zhang21Li Liu22Junhua Dong23Dongmei Zhao24Shaoqing Ni25Shaoqing Ni26Junfen Fu27Junfen Fu28Department of Pharmacy, The Children’s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, ChinaDepartment of Endocrinology, The Children’s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, ChinaDepartment of Endocrinology, The Children’s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, ChinaDepartment of Pharmacy, The Children’s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, ChinaDepartment of Pediatrics, Ningbo Women’s and Children’s Hospital, Ningbo, ChinaDepartment of Pediatric Endocrine Genetics and Metabolism, Chengdu Women’s and Children’s Center Hospital, Chengdu, ChinaDepartment of Pediatrics, Wuhu First People’s Hospital, Wuhu, ChinaDepartment of Pediatrics, First Affiliated Hospital of Army Medical University (Third Military Medical University), Chongqing, ChinaDepartment of Pediatrics, The First Affiliated Hospital of Xiamen University, Xiamen, ChinaDepartment of Endocrinology and Genetics, Shanghai Children’s Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, ChinaDepartment of Genetics and Endocrinology, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, China0Department of Pediatrics, The Second Affiliated Hospital of Anhui Medical University, Hefei, China1Department of Child Health Care, Liuzhou Maternity and Child Healthcare Hospital, Liuzhou, China2Department of Pediatrics, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China3Department of Pediatrics, Zhejiang Provincial Hospital of Chinese Medicine, Hangzhou, China4Department of Pediatrics, Zhejiang Provincial People’s Hospital, People’s Hospital of Hangzhou Medical College, Hangzhou, China5Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning, China6Department of Pediatrics, Xiangya Hospital, Central South University, Changsha, China7Department of Pediatrics, The Second Xiangya Hospital, Central South University, Changsha, China8Department of Pediatrics, Changchun Children’s Hospital, Changchun, China9Department of Pediatrics, Hangzhou First People’s Hospital, Hangzhou, China0Department of Pediatrics, Shaoxing Second Hospital, Shaoxing, China1Department of Genetics and Endocrinology, Guangzhou Women and Children’s Medical Center, Guangzhou, China2Department of Pediatrics, Qilu Hospital of Shandong University, Jinan, China3Pediatric Research Institute, Qilu Children’s Hospital of Shandong University, Jinan, China4National Clinical Trial Institute, The Children’s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China5Research Center for Clinical Pharmacy, Zhejiang University, Hangzhou, ChinaDepartment of Endocrinology, The Children’s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China6The Children’s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, ChinaObjective: Polyethylene glycol recombinant human growth hormone (PEG-rhGH, Jintrolong®) is the first long-acting rhGH preparation that is approved to treat children with growth hormone deficiency (GHD) in China. Clinical experience with dose selections of PEG-rhGH is scarce. The present study compared the efficacy and safety of a lower dose to increase dosing regimens of PEG-rhGH treatment.Methods: A multicenter, randomized, open-label, dose-comparison clinical study was conducted to compare the improvements in the height standard deviation score (Ht SDS), height velocity (HV), insulin-like growth factor-1 (IGF-1) SDS, and safety profiles of children with GHD who are treated with 0.2 mg/kg/week of PEG-rhGH dose or 0.14 mg/kg/week for 26 weeks.Results: Ht SDS, HV, and IGF-1 SDS increased significantly after PEG-rhGH treatment in the two dose groups (p < 0.05). The improvements of Ht SDS, HV, and IGF-1 SDS were more significant in the high-dose group than in the low-dose group (p < 0.05). Ht SDS improvement in low-dose group was not non-inferiority to that in the high-dose group (p = 0.2987). The incidences of adverse events were comparable between the two groups.Conclusion: The improvements of Ht SDS, HV, and IGF-1 SDS were more significant in the high-dose group than in the low-dose group (p < 0.05). PEG-rhGH at the dose of 0.14 mg/kg/week was effective and safe for children with GHD.Clinical Trial Registration:clinicaltrials.gov, identifier NCT02908958.https://www.frontiersin.org/articles/10.3389/fphar.2022.955809/fullPEG-rhGHGHDIGF-1dosechildren |
| spellingShingle | Zhouhong Jiang Xuefeng Chen Guanping Dong Yin Lou Jianping Zhang Xinran Cheng Jiayan Pan Wei Liao Jinzhun Wu Xiaodong Huang Xianjiang Jin Deyun Liu Ting Zeng Shunye Zhu Qin Dong Xiaoming Luo Dan Lan Lizhi Cao Xingxing Zhang Jing Liu Mingjuan Dai Manyan Zhang Li Liu Junhua Dong Dongmei Zhao Shaoqing Ni Shaoqing Ni Junfen Fu Junfen Fu Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study Frontiers in Pharmacology PEG-rhGH GHD IGF-1 dose children |
| title | Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study |
| title_full | Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study |
| title_fullStr | Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study |
| title_full_unstemmed | Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study |
| title_short | Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study |
| title_sort | short term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency a randomized dose comparison study |
| topic | PEG-rhGH GHD IGF-1 dose children |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.955809/full |
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