{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T02:35:52Z","timestamp":1789785352719,"version":"4.0.1"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2023,1,8]],"date-time":"2023-01-08T00:00:00Z","timestamp":1673136000000},"content-version":"vor","delay-in-days":87,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2022,10,13]],"date-time":"2022-10-13T00:00:00Z","timestamp":1665619200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["eje.bioscientifica.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,11,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the safety and efficacy of weekly PEGylated-recombinant human growth hormone (PEG-rhGH) in children with idiopathic short stature (ISS) in China.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design and methods<\/jats:title>\n                    <jats:p>This was a multicenter, phase II study in which all subjects were randomized 1:1:1 to weekly s.c. injections of PEG-rhGH 0.1 (low-dose (LD) group) or 0.2 mg\/kg\/week (high-dose (HD) group) or control for 52 weeks. The primary end point was change (\u0394) in height s.d. score (HT-SDS) from baseline to week 52. Secondary end points were height velocity (HV), bone maturity, insulin-like growth factor-1 (IGF-1) SDS, and IGF-1\/insulin-like growth factor-binding protein-3 (IGFBP-3) molar ratio.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 360 children with ISS were recruited in the study (n = 120 in each group). At week 52, \u0394HT-SDS was 0.56 \u00b1 0.26, 0.98 \u00b1 0.35, and 0.20 \u00b1 0.26 in the LD, HD, and control groups, respectively (within-group P &amp;lt; 0.0001; intergroup P &amp;lt; 0.0001). Statistically significant values of \u0394HV, IGF-1, IGF-1\/IGFBP-3 ratio, and IGF-1 SDS at week 52 from baseline were observed in both treatment groups (P &amp;lt; 0.0001). There were clear dose-dependent responses for all auxological variables. PEG-rhGH was well tolerated throughout the treatment period with treatment-emergent adverse events (TEAEs) reported in 86.5%, 84.6%, and 91.3% of children in the HD, LD, and control groups, respectively. The incidence of TEAEs was similar in all treatment groups despite the difference in doses. A total of 27 (8.7%) children experienced drug-related TEAEs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Fifty-two-week treatment with PEG-rhGH 0.1 or 0.2 mg\/kg\/week achieved significant improvement in HT-SDS and other growth-related variables, including HV, IGF-1 SDS, and IGF-1\/IGFBP-3 ratio, in a dose-dependent manner. Both doses were well tolerated with similar safety profiles.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1530\/eje-22-0449","type":"journal-article","created":{"date-parts":[[2022,9,21]],"date-time":"2022-09-21T14:21:51Z","timestamp":1663770111000},"page":"709-718","update-policy":"https:\/\/doi.org\/10.1530\/crossmarkpolicy-7","source":"Crossref","is-referenced-by-count":25,"title":["Long-acting PEGylated growth hormone in children with idiopathic short stature"],"prefix":"10.1093","volume":"187","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3748-4817","authenticated-orcid":false,"given":"Xiaoping","family":"Luo","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology , Wuhan, Hubei, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sha","family":"Zhao","sequence":"additional","affiliation":[{"name":"Children's Health Center, Hunan Children's Hospital , 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