Abstract
The efficacy and safety of human growth hormone (GH) was studied for two years in children of short-stature due to IUGR. The dosages examined were 0.5 IU/kg/week (0.5 IU group) and 1.0 IU/kg/week (1.0 IU group). In both groups, the height SDS after 12 and 24 months of the administration showed a significant improvement over the starting height SDS, and the improvement of the 1.0 IU group was significantly greater than that of the other group, at 12 and 24 months of the administration. The growth rate at the 12th and 24th months had improved significantly over that of the starting point in both groups, but no significant difference was observed between the two groups. Bone age did not progress greatly beyond the children’s chronological age during the administration, and no significant difference in bone age progress was observed between the two groups. There were no abnormal changes in laboratory test results, subjective symptoms or objective findings that were thought to affect the safety profile evaluation of the test articles. On the basis of these results, GH is thought to be effective and safe for children of short stature due to IUGR. Furthermore, based on the height SDS data obtained in this study, 1.0 IU/kg/week is assumed to be an appropriate dosage for the clinical treatment of IUGR short stature.
