Clinical Effects of E. cole Derived Authentic REcombinant Human Growth Hormone(DA-3002) in Children with Growth Hormone Deficiency.
- Author:
Se Won YANG
;
Byung Chul LEE
;
Chul Woo KO
;
Duk Hee KIM
;
Han Wook YOO
;
Woo Young CHUNG
- Publication Type:Original Article
- Keywords:
Human growth hormone;
DA-3002;
Growth hormone deficiency
- MeSH:
Arginine;
Blood Cell Count;
Body Height;
Chemistry;
Child*;
DNA, Recombinant;
Escherichia coli;
Growth Hormone*;
Human Growth Hormone;
Humans*;
Hypoglycemia;
Insulin-Like Growth Factor I;
Korea;
Levodopa;
Plasma;
Thyroid Gland;
Urinalysis;
Vital Signs
- From:Journal of Korean Society of Endocrinology
1998;13(4):526-535
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND: Recently authentic human growth hormone(hGH) has produced in the E coli K-12, W3110 by recombinant DNA tecbnology in Korea In this paper, the clinical efficacy and immunogenicity of this GH was shdied in 38 children with growth hormone deficiency during therapy of 1 year. METHODS: The subjects of this study were aged 4.9-13.9 years, diagnosed by failure of plasma GH to respond to insulin-induced hypoglycemia, arginine and/or L-dopa loading and height below -2 standard deviation of mean for their chronological age. Each patient received GH 0.5-0.7IU/kg/week subcutaneously in 6-7 divided doses. During treatment, vital signs, height, body weight and bone age were checked every 3 months. Complete blood count, urinalysis, blood chemistry and thyroid hormone were checked before and every 6 months. The measurement of serum IGF-1 level and antibody against hGH were performed before and every 6 months during therapy of I year. RESULT: The height velocities significantly increased from 3.3 +/- 1.5cm/year to 10.1 +/- 2.5 and 9.0 +/- 1.8cm/year at 6 and 12 months of therapy, respectively. The height standard deviation score for chronological age were significantly improved from -2.141.50 to -1.74 +/- 1.43 and -1.54 +/- 1.38 at 6 and 12 months of therapy with increasing ratio of bone age to chronological age from 0.72 +/- 0.15 at pretreatment to 0.76 +/- 0.15 at 6 month, 0.79 +/- 0.16 at 12 month of therapy. The plasma IGF-1 level significantly increased during treatment. One of 36 patients(2.8%) showed positive antibody against hGH after 1 year of treatment. During therapy of 1 year, unwanted and remarkable clinical side effect were not observed in all subjects. CONCLUSION: These results indicate that this E. coli derived authentic recombinant growth hormone is very effective in stimulating linear growth in children with growth hormone deficiency.
