Journal of Korean Endocrine Society 1998;13(4):526-535.
Published online January 1, 2001.
Clinical Effects of E. cole Derived Authentic REcombinant Human Growth Hormone(DA-3002) in Children with Growth Hormone Deficiency.
Se Won Yang, Byung Chul Lee, Chul Woo Ko, Duk Hee Kim, Han Wook Yoo, Woo Young Chung
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.
Key Words: Human growth hormone, DA-3002, Growth hormone deficiency

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