Clinical trial of long-acting and short-acting recombinant human growth hormone in the treatment of children with idiopathic short stature
Objective To observe clinical curative effect of long-acting recombinant human growth hormone(rhGH)and short-acting rhGH,and their influences on growth and development indexes,serum thyroid function indexes and insulin in children with idiopathic short stature(ISS).Methods The children with ISS were randomly divided into long-acting group[subcutaneous injection of polyethylene glycol recombinant human growth hormone(0.2 mg·kg-1·w-1,qw)]and short-acting group[subcutaneous injection of recombinant human growth hormone(0.15 U·kg-1·d-1)at 30 min before sleep every night].All children were treated for 12 months.The growth and development[growth velocity(GV),height standard deviation of points(Ht SDS)],thyroid function,fasting insulin(FINS)and insulin-like growth factor-1(IGF-1)were compared between the two groups.The occurrence of adverse reactions was recorded.Results In the 68 children,there were 4 cases with loss to follow-up and shedding due to personal reasons.Finally,there were 33 cases in long-acting group and 31 cases in short-acting group for statistical analysis.After 6 months of treatment,GV in long-acting group and short-acting group were(4.53±0.56)and(3.97±0.48)cm·year-1,Ht SDS were-2.45±0.23 and-2.66±0.21,IGF-1 levels were(551.62±41.48)and(524.36±37.84)mg·mL-1,respectively.After 12 months of treatment,GV in long-acting group and the short-acting group were(9.44±0.82)and(8.46±0.77)cm·year-1,Ht SDS were-1.68±0.19 and-1.91±0.20,IGF-1 levels were(642.46±36.49)and(593.14±40.12)mg·mL-1,differences were statistically significant(all P＜0.05).There were no significant differences in FT3,FT4,TSH and FINS between the two groups after treatment(all P＞0.05).There was no significant difference in the total incidences of adverse drug reactions between long-acting group and short-acting group[6.06％(2 cases/33 cases)vs 12.90％(4 cases/31 cases),P＞0.05].Conclusion Compared with short-acting rhGH,promotion effect of long-acting rhGH is better on short-term growth and development in ISS children,which can increase level of serum IGF-1 and has no obvious effects on thyroid function,with good safety.
long-acting recombinant human growth hormoneshort-acting recombinant human growth hormoneinsulinidiopathic short staturegrowth and developmentthyroid function
国家科技期刊平台
NSTL
万方数据
