Clinical Observation On Treatment Of Children Growth Hormone Deficiency By Polyethlene Glycol Recombinant Human Growth Hormone

Objective: To analyze clinical efficacy,safety and compliance of polyethylene glycol recombinant human growth hormone(PEG-rhGH)therapy in children with growth hormone deficiency(GHD).Methods: 36 children with GHD admitted to the affiliated hospital of Qingdao university from July 2016 to June 2019 were selected,and 33 cases were finally retained according to the criteria of diagnosis,inclusion,exclusion and shedding.According to different treatment methods,they were divided into three groups: short-acting treatment group,low-dose group and high-dose group.According to the wishes of children and their families they are voluntarily take part in the program of phase Ⅳ clinical study of PEG-rhGH therapy in children with GHD voluntarily with sufficient informed consent.They were randomly given low-dose(0.12 mg/kg PEG-rhGH treatment and high-dose(0.2 mg/kg PEG-rhGH)treatment.6 cases in low-dose group were treated with 0.12mg/kg PEG-rhGH weekly,and after 6 months of treatment,the dose was adjusted to 0.20mg/kg to maintain the treatment for 24 months.7 cases in the high dose group were treated with 0.20 mg/kg PEG-rhGH weekly.20 cases treated with short-acting recombinant human growth hormone were as control group.All children were fully tested before treatment and recheck every three months after treatmen.We measured and recorded their growth and development and assessed their growth factor,function of thyroid,glucolipid metabolism,bone age and so on.We compared at baseline,6 months,12 months,18 months and 24 months on height velocity,height standard deviation score(HtSDS),insulin-like growth factor-1(IGF-1),bone maturity,free triiodothyronine(FT3),free thyroid hormone(FT4),serum thyroid stimulating hormone(TSH),fasting blood glucose,glycosylated hemoglobin,insulin,total cholesterol,low-density lipoprotein.We analyzed adverse reaction and the drug leakage frequency of three group of GHD children and evaluated their treatment compliance.Results: 1.The height velocity levels of the three groups of GHD children after treatment were all higher than those before treatment,the difference was statistically significant(P < 0.05).High dose group got higher height velocity than low dose group at six months but without statistical difference with short-acting treatment group.There was no significant difference on height velocityin three group in other time.High dose group got higher Ht SDS than low dose group at six months but without statistical differencewith short-acting treatment group.There was no significant difference in the levels of Ht SDS among the three groups in other time(P> 0.05).2.The IGF-1 level of the three groups after treatment was higher than that before treatment,the difference was statistically significant(P < 0.05).High dose group got higher height IGF-1 than low dose group at six months but without statistical difference with short-acting treatment group.There was no statistical significance between three group at other stage(P > 0.05).3.There was no difference in BA/CA levels at every stage of treatment(P> 0.05).4.There was no significant difference in FT3,FT4 and TSH levels between the three groups at different stages(P > 0.05),and there was no significant difference in FT3,FT4 and TSH levels before and after treatment(P > 0.05).5.There was no significant difference in fasting blood glucose,HbA1 c and insulinlevel between the three groups at different stages(P > 0.05),and there was no significant difference in fasting blood glucose,HbA1 c and insulinlevel before and after treatment(P > 0.05).6.There was no significant difference in total cholesterol and low-density lipoprotein levels between the three groups at different stages(P > 0.05),and there was no significant difference in total cholesterol and low-density lipoprotein levels before and after treatment(P > 0.05).7.There were 8 cases of induration at the injection site,2 cases of male breast development,1 case of headache,1 case of red and swollen at the injection site and 1 case of edema in the short-term treatment group,1 case of male breast development in the low-dose group,1case of induration at the injection site in the high-dose group.And no other significant adverse events happened.8.The treatment compliance rate of children in low dose group and high dose group was higher than that in the short-acting treatment group,and the difference was statistically significant(P < 0.05).Conclusion: 1.PEG-rhGH replacement therapy is as effective as short-acting growth hormonein improving the symptoms of short stature in GHD children,increasing the level of growth factor and promoting the growth and development of children.2.Height velocity,Ht SDS and IGF-1 of high dose of PEG-rhGHgroup were higher than low dose of PEG-rhGHat 6 months.High dose at beginning can improve height velocity prominently,enhance therapeutic confidence,and improve compliance.3.There was nosevere adverse event in the 2 years of PEG-rhGH therapy and the therapy was relatively safe.The effects on bone maturity,thyroid function,glucose metabolism,lipid metabolism and other aspects still need long-term monitoring,so as to ensure the treatment safety of GHD children.4.The compliance of PEG-rhGH replacement therapy was significantly higher than that of short-acting growth hormone.