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The Pharmacokinetics and Biological Effects of Yeat Dervied Recombinant Methionyl Growth Hormone in growth Hormone Deficient Children

Journal of the Korean Pediatric Society 1992;35(3):349-354.
Published online March 15, 1992.
The Pharmacokinetics and Biological Effects of Yeat Dervied Recombinant Methionyl Growth Hormone in growth Hormone Deficient Children
Byung Churl Lee
Department of Pediatrics, Catholic University Medical College, Seoul, Korea
성장호르몬 결핍증 환아에서 국내에서 합성한 인간성장호르몬의 약물동태
이병철
가톨릭의과대학 소아과학교실
Abstract
The parmacokinetics and biological effects of an recombinant methionyl growth hormone(LBD-003) produced by the expression of genomic hGH in a yeast cell line, were studied in growth hormone deficient children. Twelve patients were randomly assigned to two age-matched subcutaneous and intramuscular groups. Each group consists of 6 patients. Each subject received an dosage of 0.1 U hGH(LBD-003)/kg, BW, Blood was drawn before hGH administration and 0.5, 1,2,3,4,5,6,7,8,9,10,11,12 and 24 hour after administration for the determination of plasman hGH levels, and before GH administration and 2,3,4,6,8,12 and 24 hour after administration for the determination of plasma IGF-I levels. 1) Mean GH concentrations in the subcutaneous group rose significantly at 2 hour after administration and continued to rise to a peak at 6 hour and returned to preinjection levels by 24 hour. However, mean GH concentrations in the intramuscular group rose significiantly to a peak at 2 hour after administration and returned to preinjection levels by 12 hour. 2) Mean IGF-I concentrations in the subcutaneous group rose significantly at 6 hour and continued to rise to a peak at 24 hour after administration. However, mean IGF-I concentrations in the intramuscular group rose significantly at 8 hour and continued to rise to a peak at 24 hour after administration. 3) The peak concentration of GH and IGF-I was no difference between subcutaneous and intramuscular group. 4)The mean time taken to achieve peak concentrations in subcutaneous group was significantly longer than that of intramuscular group. These results suggest that this yeast derived recombinant methionlyl growth hormone possesses the pharmacokinetics and biological properties similar to pituitary GH and authentic GH in growth hormone deficient childre.
Key Words: Pharmacokinetics, recombinant growth hormone, growth hormone deficient children


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