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Current Clinical Trials with Authentic Recombinant Human Growth Hormone in Japan
Author(s) -
TAKANO KAZUE,
SHIZUME KAZUO
Publication year - 1986
Publication title -
acta pædiatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1111/j.1651-2227.1986.tb10373.x
Subject(s) - medicine , human growth hormone , current (fluid) , recombinant dna , clinical trial , growth hormone , intensive care medicine , family medicine , hormone , biochemistry , chemistry , gene , electrical engineering , engineering
. Daily injections of methionine‐free, recombinant hGH (rhGH), 8IU, were administered in six healthy volunteers. Non‐esterified fatty acid levels increased significantly from 0.45 ± 0.06 to 1.08 ± 0.05 mEq/litre (mean ± SEM) at 4 hours after the first injection of rhGH (p < 0.001). Plasma IGF‐1 levels increased significantly at 24 hours after each of the four daily injections of rhGH (basal, 0.80 ± 0.06 units/ml; 24 hours, 1.72 ± 0.21 units/ml; 48 hours, 3.22 ± 0.42 units/ml; 72 hours, 3.17 ± 0.49 units/ml; 96 hours, 3.63 ± 0.32 units/ml; p < 0.001). Eleven patients with hGH deficiency were treated with rhGH, 0.5 IU/kg/week for 3 months. Their heights increased by between 1.1 cm and 4.1 cm during the 3 months of treatment, which was calculated to be equivalent to 4.4–16.4 cm/year, with a mean height velocity of 8.6 ±1.1 cm/year. Anti‐hGH antibody was observed in one patient treated with rhGH and had a titre of 10.