TY - JOUR
T1 - Design of the long-term observational cohort study with recombinant human growth hormone in korean children
T2 - LG growth study
AU - Chung, Sochung
AU - Yoo, Jae Ho
AU - Choi, Jin Ho
AU - Rhie, Young Jun
AU - Chae, Hyun Wook
AU - Kim, Jae Hyun
AU - Hwang, Il Tae
AU - Shin, Choong Ho
AU - Kim, Eun Young
AU - Lee, Kee Hyoung
N1 - Publisher Copyright:
© 2018 Annals of Pediatric Endocrinology & Metabolism.
PY - 2018/3
Y1 - 2018/3
N2 - 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.
AB - 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.
KW - Chronic renal failure
KW - Growth hormone deficiency
KW - Idiopathic short stature
KW - Small for gestational age
KW - Turner syndrome
UR - http://www.scopus.com/inward/record.url?scp=85061516573&partnerID=8YFLogxK
U2 - 10.6065/apem.2018.23.1.43
DO - 10.6065/apem.2018.23.1.43
M3 - Article
AN - SCOPUS:85061516573
SN - 2287-1012
VL - 23
SP - 43
EP - 50
JO - Annals of Pediatric Endocrinology and Metabolism
JF - Annals of Pediatric Endocrinology and Metabolism
IS - 1
ER -