| Abstract: | Recombinant human growth hormone (rhGH) has been widely used in the clinical treatment of growth hormone deficiency. To simplify
the injection process and increase drug compliance, application of the GH injection has become a new treatment plan in recent
years. The purpose of the current study was to evaluate the efficacy and safety of rhGH injection for the treatment of growth
hormone deficiency (GHD) in children in China. In a nationwide, noncomparative, prospective, randomized, open trial, 31 children
with confirmed complete GHD received subcutaneous injection of rhGH at 0.25 mg/kg·wk (0.107 IU/kg·d). The injection was given
daily and the total weekly amount was separated into 6–7 injections. The patients were followed up at 3-month intervals and
the treatment duration was 12 months. The height (HT), annual growth velocity (GV), mean height standard deviation score (HT
SDS), blood serum insulin-like growth factor I (IGF-I), insulin-like growth factor binding protein 3 (IGFBP-3), and bone maturity
before and after treatment were compared, and the safety of the treatment was analyzed. The mean HT, GV, and HT SDS were increased
from 109.0±14 cm, 2.7±0.9 cm/yr, and −4.62 ±1.46 at baseline to 121.8±13.4 cm, 12.9±3.3 cm/yr, and −2.47±1.86 after 12 months
of treatment, respectively (P<0.001). At the same time, blood IGF-I and IGFBP- 3 were increased significantly 41.27±64.43 μg/L vs 159.21±167.92 μg/L and 1540.00±1325.11 mg/L vs 3533.93±1413.82 mg/L, respectively (P<0.001)]. The bone age assessments performed 6 and 12 months after the treatment showed that no advanced bone maturation was
noted. No serious adverse events occurred during the treatment, and the drug-related adverse events were mainly decreased
thyroid function. We conclude that rhGH injection is a safe and effective drug for treatment of growth hormone deficiency
in children. |
