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KMID : 1036920180230010043
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Annals of Pediatric Endocrinology & Metabolism
2018 Volume.23 No. 1 p.43 ~ p.50
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Design of the long-term observational cohort study with recombinant human growth hormone in Korean children: LG Growth Study
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Chung So-Chung
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
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Abstract
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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).
Conclusions: 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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KEYWORD
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Growth hormone deficiency, Turner syndrome, Chronic renal failure, Small for gestational age, Idiopathic short stature
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