성장호르몬 결핍증 환아에서 국내의 유전자재조합기술로 합성된 성장호르몬(DA-3002)의 성장효과

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. (J kor Soc Endocrinol 13: 526-535, 1998)