Design of the long-term observational cohort study with recombinant human growth hormone in Korean children: LG Growth Study
- Authors
- Chung, Sochung; Yoo, Jae-Ho; Choi, Jin Ho; Rhie, Young-Jun; Chae, Hyun-Wook; Kim, Jae Hyun; Hwang, Il Tae; Shin, Choong Ho; Kim, Eun Young; Lee, Kee-Hyoung
- Issue Date
- 3월-2018
- Publisher
- KOREAN SOC PEDIATRIC ENDOCRINOLOGY
- Keywords
- Growth hormone deficiency; Turner syndrome; Chronic renal failure; Small for gestational age; Idiopathic short stature
- Citation
- ANNALS OF PEDIATRIC ENDOCRINOLOGY & METABOLISM, v.23, no.1, pp.43 - 50
- Indexed
- SCOPUS
KCI
- Journal Title
- ANNALS OF PEDIATRIC ENDOCRINOLOGY & METABOLISM
- Volume
- 23
- Number
- 1
- Start Page
- 43
- End Page
- 50
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/76851
- DOI
- 10.6065/apem.2018.23.1.43
- ISSN
- 2287-1012
- Abstract
- Purpose: Regarding recombinant human growth hormone (rhGH) use in the pediatric population, no long-term follow-up data are available for Korean patients. To fill in the gap of knowledge, a registry study (LG Growth Study) was initiated to assess the safety and effectiveness of four types of rhGH products in real-life settings. Methods: A total of 4,000 children will be registered and prospectively followed up at 6-month intervals until 2 years after epiphyseal closure to collect data on treatment and adverse events, with primary interest in malignancies and growth outcomes. Results: As of 22 March 2017, approximately 50% (2,024) of the target number of patients have been included in the analysis set: growth hormone deficiency, 1,297 (64.1%); idiopathic short stature, 315 (15.6%); small for gestational age, 206 (10.2%); Turner syndrome, 197 (9.7%); and chronic renal failure, 9 (0.4%). At baseline, median age (years) was 8 (interquartile range [IQR], 5-11); 52% (1,048) were boys; and the majority were at Tanner stage I (83% based on breast/external genitalia, 97% on pubic hair). Median height standard deviation score was -2.26 (IQR, -2.69 to -2.0), and median bone age delay (years) was -1.46 (IQR, -2.26 to -0.78). Conclusion: This registry study will provide the opportunity to assess the risk of malignancies as well as the general safety data in Korean pediatric patients receiving rhGH. In addition, the long-term effectiveness of rhGH and comparative data between different disease entities will provide practical insight on the standard rhGH treatment.
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