Efficacy,safety And Compliance Of Phase Ⅳ Clinical Trial Of PEG-rhGh In The Treatment Of Children With GHD

Objective: to evaluate the efficacy,safety and compliance of PEG recombinant human growth hormone(PEG-rhGh)in the treatment of short stature in children with endogenous growth hormone deficiency(GHD).Methods: this study was a randomized controlled clinical trial.A total of 81 untreated children with GHD who met the inclusion criteria were selected for the study.The subjects were randomly divided into three groups: 19 patients received a weekly dose of 0.14 mg /kg/w PEG-rhGh;22 patients received a weekly dose of 0.2mg/kg/w PEG-rhGh;and 40 patients received a daily dose of 0.15 IU/kg/d short-effect growth hormone.The total treatment course was 26 weeks,and 4 visits were conducted at baseline,4 weeks after treatment,13 weeks and 26 weeks respectively.The standard deviation score of height,growth rate,serum igf-1sds,fasting blood glucose,thyroid function,blood lipid and drug leakage were compared between the three groups before and after treatment.Results: The standard deviation score of the group receiving weekly PEG-rhGh 0.14 mg /kg/w dose increased from-2.6 to-2.33,the growth rate increased from 3.74±1.37 to 8.94±2.124,and the growth rate of igf-1sds increased from-1.42 to-0.24.The growth rate of the group receiving weekly PEG-rhGh 0.2mg/kg/w dose increased from-2.5 to-2.05,the growth rate increased from 3.45±1.01 to 10.56±2.723,and the igf-1sds increased from-1.33 to 0.22.The standard deviation of the daily 0.15 IU/kg/d dose of short-acting human growth hormone increased from-2.7 to-2.32,the growth rate increased from 3.55±1.01 to 10.84±3.013,and the igf-1sds increased from-1.28 to 0.09.The therapeutic effect of peg recombinant human growth hormone was better than that of short-acting human growth hormone,and the bone age progression was consistent with the age.There were no significant differences in fasting blood glucose,thyroid function and lipid levels between the three groups after treatment(P >,0.05).In total,the needle leakage rate of 41 patients in the PEG-rhGh treatment group was 0.38%,less than the short acting growth hormone needle leakage rate of 0.96%,and the statistical difference between the two groups was significant.Conclusion: the effect of PEG-rhGh in the treatment of children’s growth hormone deficiency is better than that of short-acting growth hormone in the short-term observation,no obvious toxic and side effects were observed,and the safety is good,and the children’s compliance is good.