Large sample clinical study on the safety and efficacy of recombinant human growth hormone in the treatment of pediatric growth hormone deficiency

Abstract

Objective Using large sample clinical study to reevaluate the safety and efficacy of recombinant human growth hormone(ANSOMONE) in treating pediatric growth hormone deficiency(GHD).Methods 1012 cases were administered with ANSOMONE at a dose of 0.1 IU · kg-1 · d -1 in bedtime for 6 months.The alteration of mean height,growth rate,height standard deviation scores,bone age,and anti-GH antibody and occurrence of adverse effects were observed.Results The growth rate was promoted from ( 2.50 ± 0.85 ) cm/year to ( 13.44 ± 4.27 ) cm/year,the net growth rate was( 10.94 ±3.69)cm/year.There was significant difference between the pre-treatment and post-treatment patients ( P ＜ 0.01 ).The post-treatment anti-GH antibody positive rate was 13.34％,which had no obvious effect on the efficacy.Few patients exert transient inflammation reactions,which disappeared with any treatment.Conclusion ANSOMONE had significant efficacy,and could promote the height increase obviously.It had good safety without any obvious side effect and early-maturing effect. Key words: Recombinant human growth hormone; Growth hormone deficiency; Efficacy; Safety; Large Sample ; Reevaluation