Abstract
Biogenetically produced authentic GH (r-HGH) of mammalian cell origin was used in a multicenter treatment trial involving GH deficient children from Austria, FRG, GDR and Switzerland after approval by ethical committees. GH was applied s.c. daily in a dose of 12 U/m2/week. Previously with GH treated (group T) and untreated (group U) patients were included. 65 patients met the selection criteria. Group U consisted of 20 males and 9 females, mean age 7.59±4.1 (SD) y, mean bone age (BA) 5.12 ± 3.43 y. Group T enclosed 28 males, 8 females, mean age 9.66 ± 3.48 y, mean BA 6.57 ± 3.01 y, pituitary GH was stopped for a period of time before r-HGH started. Results: After 6 months of treatment: Group U: Mean growth velocity increased from 3.06 ± 0.81 to 10.26 ± 2.5 cm/y, mean height standard deviation score (SDS) for age was reduced from -3.45 ± 1.27 to -2.97 ± 1.1 and height age (HA): BA ratio increased from 1.02 ± 0.24 to 1.12 ± 0.33. Group T: Growth velocity increased from 3.16 ± 1.98 to 8.8 ± 2.35 cm/y, mean height SDS was reduced from -2.73±1.91 to -2.42 ± 1 .76. HA: BA ratio improved from 0.97 ± 0.27 to 1.08 ± 0.26. In both groups Somatomedin C levels rose. One of 65 children developed GH antibodies, no antibodies to non r-HGH-protein could be detected. No clinically visible side effects were observed. Conclusion: This new type of r-HGH is effective and an alternative to r-HGH produced in E. coli bacteria.
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Stybbe, P., Stahnke, N. R-HGH OF MAMMALIAN CELL ORIGIN FOR THE TREATMENT OF GROWTH HORMONE (GH) DEFICIENCY IN CHILDREN. Pediatr Res 23, 116 (1988). https://doi.org/10.1203/00006450-198801000-00091
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DOI: https://doi.org/10.1203/00006450-198801000-00091