300 459

Cited 4 times in

Recombinant growth hormone therapy for prepubertal children with idiopathic short stature in Korea: a phase III randomized trial

Authors
Kim, J | Suh, BK | Ko, CW | Lee, KH | Shin, CH | Hwang, JS  | Kim, HS | Chung, WY | Kim, CJ | Han, HS | Kwon, NY | Cho, SY | Yoo, HW | Jin, DK
Citation
Journal of endocrinological investigation, 41(4). : 475-483, 2018
Journal Title
Journal of endocrinological investigation
ISSN
0391-40971720-8386
Abstract
PURPOSE: Several studies have evaluated the effects of growth hormone (GH) on auxological and biochemical parameters in children with non-GH-deficient, idiopathic short stature (ISS). This study evaluated the efficacy and safety of Growtropin((R))-II (recombinant human GH) in Korean patients with ISS.
METHODS: This was a 1-year, open-label, multicenter, phase III randomized trial of Growtropin((R))-II in Korean patients with ISS. In total, 70 prepubertal subjects (39 males, 31 females) between 4 and 12 years of age were included in the study. All patients were naive to GH treatment.
RESULTS: Annual height velocity was significantly higher in the treatment group (10.68 +/- 1.95 cm/year) than the control group (5.72 +/- 1.72, p < 0.001). Increases in height and weight standard deviation scores (SDSs) at 26 weeks were 0.63 +/- 0.16 and 0.64 +/- 0.46, respectively, for the treatment group, and 0.06 +/- 0.15 and 0.06 +/- 0.28, respectively, for the control group (p < 0.001). Serum insulin-like growth factor (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3) increased significantly in the treatment group at week 26 compared to baseline. However, the SDS for body mass index (BMI) at 26 weeks did not change significantly in either group. Growtropin((R))-II was well tolerated and safe over 1 year of treatment.
CONCLUSIONS: One-year GH treatment for prepubertal children with ISS demonstrated increased annualized velocity, height and weight SDSs, and IGF-1 and IGFBP-3 levels, with a favorable safety profile. Further evaluations are needed to determine the optimal dose, final adult height, and long-term effects of ISS treatment.
Keywords
MeSH

DOI
10.1007/s40618-017-0786-8
PMID
29103133
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Pediatrics & Adolescent Medicine
Ajou Authors
황, 진순
Full Text Link
Files in This Item:
29103133.pdfDownload
Export

qrcode

해당 아이템을 이메일로 공유하기 원하시면 인증을 거치시기 바랍니다.

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse