Clinical trial of recombinant human growth hormone in treatment of children with growth hormone deficiency
10.13699/j.cnki.1001-6821.2025.01.007
- VernacularTitle:重组人生长激素治疗生长激素缺乏症儿童的临床研究
- Author:
Qiu-yue TAN
1
;
Yong DENG
1
;
Yue-qiong SHI
1
Author Information
1. 简阳市人民医院儿科,四川简阳 641400
- Publication Type:Journal Article
- Keywords:
recombinant human growth hormone injection;
stanozolol tablet;
growth hormone deficiency;
influencing factors;
growth rate
- From:
The Chinese Journal of Clinical Pharmacology
2025;41(1):31-35
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the clinical effects and influencing factors of recombinant human growth hormone(rhGH)treatment in pediatric patients with growth hormone deficiency.Methods The study subjects were pediatric patients with growth hormone deficiency,all of whom received a combination therapy of stanozolol tablets 2 mg(qd)and 0.1 U·kg-1·d-1 of recombinant human growth hormone injection for a continuous period of one year.After one year,the patients were divided into active group and invalid group based on clinical outcomes.Comparisons were made between the two groups in terms of height,annual growth velocity(GV)and height standard deviation score(HtSDS)before and after treatment,and safety evaluations were conducted.Multivariate Logistic regression analysis was used to identify factors that influenced the treatment outcomes in pediatric patients with growth hormone deficiency.Results After one year of treatment,a total of 93 cases pediatric patients were included in the analysis,with 62 cases in the active group and 31 cases in the invalid group.The heights of the patients before and after treatment were(119.40±2.48)and(129.08±2.37)cm,respectively;the GV were(3.08±0.39)and(7.34±1.02)cm·year-1,respectively;the HtSDS were-2.45±0.49 and-1.68±0.35,respectively,with statistically significant differences observed for all comparisons(all P＜0.05).In the active and invalid groups,the proportions of patients with GV＜3.0 cm·year-1 before treatment were 32.26％and 58.06％,respectively;the proportions of patients with peak growth hormone(GH)levels＜5.0 ng·mL-1 before treatment were 30.65％and 54.84％,respectively;the average maternal heights were(158.83±5.76)and(155.48±6.58)cm,respectively,with statistically significant differences observed for all comparisons(all P＜0.05).The results of the Logistic regression model showed that GV＜3.0 cm·year-1 before treatment,peak GH levels＜5.0 ng·mL-1 before treatment,and a shorter maternal height were independent risk factors for poor treatment outcomes with rhGH in pediatric patients with growth hormone deficiency(all P＜0.05).No severe adverse reactions occurred during the treatment of any patient;seven patients experienced pain at the injection site,one patient had a slight increase in blood glucose,and five patients had mild decreased appetite.The total incidence of adverse drug reactions were 13.98％(13 cases/93 cases).Conclusion Treatment with rhGH for pediatric patients with growth hormone deficiency can significantly improve height development and has good safety,but it is influenced by factors such as growth velocity,peak GH levels,and maternal height.
