J Korean Soc Endocrinol.  1998 Dec;13(4):526-535.

Clinical Effects of E. cole Derived Authentic REcombinant Human Growth Hormone(DA-3002) in Children with Growth Hormone Deficiency

• Yang SW
• Lee BC
• Ko CW
• Kim DH
• Yoo HW
• Chung WY

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.

MeSH Terms

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
Arginine
DNA, Recombinant
Growth Hormone
Human Growth Hormone
Insulin-Like Growth Factor I
Levodopa