Clinical Study Of Polyethylene Glycol Recombinant Human Growth Hormone In The Treatment Of Prepubertal Idiopathic Short Stature

Objective:To analyze the clinical efficacy and safety of polyethylene glycol recombinant human growth hormone（PEG-rh GH）in the treatment of prepubertal idiopathic short stature（ISS）,and to provide an important reference for clinical application of PEG-rh GH in the treatment of ISS.Methods:From June 2018 to March 2021,50 children with ISS before puberty treated in Shanxi Children’s Hospital were selected as the study subjects.They were divided into three groups according to different treatment plans.20 patients in long-acting treatment group were treated with PEG-rh GH 0.20mg/（Kg· week）combined with routine intervention.20 patients in short-acting treatment group were treated with recombinant human growth hormone（rh GH）0.15IU/（Kg·d）combined with routine intervention.10 patients in control group was treated with routine intervention.The course of treatment is 12 months.Comprehensive examination was completed before treatment in the three groups,and growth and development as well as related laboratory indicators were monitored every 3months after treatment.Comparison of three groups of children before and after treatment for 6 months and 12 months of growth rate,the standard deviation of integral height（Ht SDS）,serum insulin-like growth factor 1（IGF-1）,bone maturity and fasting insulin,fasting blood sugar,triglyceride,total cholesterol,serum thyroid stimulating hormone（TSH）and free thyroxine（FT4）,free iodine thyroid glycine（FT3）,adverse reactions during treatment were recorded.Results:1.The growth rate and Ht SDS of long-acting treatment group and short-acting treatment group were significantly increased after treatment compared with before treatment,with statistical significance（P < 0.05）.After 6 and 12 months of treatment,the growth rate and Ht SDS of long-acting treatment group and short-acting treatment group were significantly higher than those of control group,and the differences were statistically significant（P < 0.05）.There were no significant differences in growth rate and Ht SDS between long-acting and short-acting treatment groups（P > 0.05）.2.The level of IGF-1 in the three groups were significantly increased after treatment compared with before treatment,the difference was statistically significant（P <0.05）.After 6 and 12 months of treatment,the level of IGF-1 in long-acting treatment group and short-acting treatment group was significantly higher than that in control group,the difference was statistically significant（P < 0.05）.The level of IGF-1 in long-acting treatment group was higher than that in short-acting treatment group,but the difference was not statistically significant（P > 0.05）.3.There was no significant difference in bone maturity among the three groups after 6months and 12 months of treatment（P > 0.05）.4.There were no significant differences in fasting insulin,fasting blood glucose,triglyceride,total cholesterol,TSH,FT4 and FT3 between the three groups before and after treatment（P > 0.05）.After 6 months and 12 months of treatment,there was no significant difference in the above indexes among the three groups（P > 0.05）.5.The incidence of other adverse reactions after treatment: there were statistically significant differences among the three groups（x₂=12.542,P=0.034）;The long-acting treatment group was significantly lower than the short-acting treatment group,the difference was statistically significant（P < 0.05）.There were no serious adverse reactions during treatment.Conclusion:1.PEG-rh GH has obvious efficacy in the treatment of prepubertal ISS,which can promote the growth and development of children and improve their lifetime height.2.PEG-rh GH has little effect on glucose and lipid metabolism and thyroid function in prepubertal ISS children,and no serious adverse reactions occurred during treatment,indicating good safety.3.There is no significant difference between PEG-rh GH and rh GH in the treatment of prepubertal ISS,but it can reduce the number of injections,relieve the pain of injections and increase the compliance of children,which has great clinical significance.