Objective:To observe the therapeutic effect of domestic recombinant human growth hormone (rhGH) in the treatment of children with growth hormone deficiency (GHD) and to explore the factors that influence the individual therapeutic effect; To investigate the changes of insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), fasting plasma glucose (FPG), thyroid function, and other related indicators during the treatment in children with GHD.Methods:In this research,104 children were diagnosed with GHD and were treated with rhGH from March 2013 to March 2015 in specialty clinic for growth and development of Affiliated Hospital of Jining Medical College. Among them,60 patients were selected as the research object whose duration of treatment was more than 6 months. Of these 60 cases,27 cases were treated for 12 months. Clinical basic data of all patients were collected. rhGH was injected subcutaneously with a daily dosage of 0.lU/Kg per night before going to bed in all children. They were followed up in clinic after treatment 1,3,6,9,12 months, The height and body mass were separately measured by the same measuring tool before and during treatment, and then growth velocity (GV), body mass index (BMI) and height standard deviation score (HtSDS) were calculated; Fasting venous blood samples were collected, which were used for the test of IGF-1, IGFBP-3, FPG, liver function, free triiodothyronine (FT3), free thyroid hormone (FT4) and thyroid stimulating hormone (TSH). Blood routine, electrolytes, renal function were separately assessed before and after treatment 3,9 months. Bone age was taken respectively before and after treatment 6, 12 months.Results:(1) 6,12 months after treatment, Ht, HtSDS, GV were significantly higher than before treatment, the differences were statistically significant (P<0.001); while there were no significant difference in BMI and BA/CA between before and during rhGH treatment (P>0.05). (2) △Ht, △ HtSDS, GV showed a gradual downward trend every 3 months after treatment. Growth response was best in the first three months of treatment. (3) △HtSDS after 12 months with rhGH treatment was positively associated with bone age delay, mid-parental height, △HtSDS in the first 3 months and △HtSDS in the first 6 months (r respectively were 0.427,0.399,0.643, 0.876, all P<0.05), while negatively associated with the age of onset, bone age, IGFBP-3 (r respectively were-0.627,-0.689,-0.566, all P<0.01). (4) 6,12 months after treatment, IGF-1, IGFBP-3 were significantly higher than that before treatment (P≤0.001). (5) The levels of FT3 and FT3/FT4 ratios both showed statistically significant increases after treatment 3,6,12 months (P<0.05), There was no significant difference among treatment of 3,6 and 12 months (P>0.05); however, FT4 and TSH levels compared with before treatment, the differences were both not statistically significant (P>0.05). The level of FT3 and FT3/FT4 ratios were both positively correlated with GV (P<0.01). The entire level of FT3 and FT3/FT4 ratios were both positively correlated with GV, HtSDS, IGF-1 before and after treatment (P<0.05). (6) The levels of FPG showed an increasing trend after treatment in children with GHD, the level of FPG was significantly higher after treatment 3,6,12 months (P<0.05), There was no significant difference between after treatment 6 and 12 months (P>0.05). (7) During treatment,2/60 cases (3.3%) and 1/27 cases (3.7%) occurred (subclinical) clinical hypothyroidism after treatment 6 months,9 months respectively; 3/60 (5%) and 1/27 cases (3.7%) occurred fasting hyperglycemia after treatment for 1 months,12 months respectively; 2/60 (3.3%) and 1/27 (3.7%) cases occurred abnormal liver function after treatment for 1 months,12 months respectively; No other severe adverse events occurred during the therapeutic course.Conclusion:(1) The replacement therapy with rhGH can significantly promote growth in children with GHD, growth response was best in the first three months of treatment. And it had less influence on BMI and bone maturity. (2) The treatment effect in the first year was positively correlated with bone age delay, mid-parental height, the early treatment response, while negatively correlated with the age of onset, bone age, IGFBP-3. (3) rhGH administration affected the metabolism of thyroid hormones, fasting blood glucose and liver function et al, Therefore we should regularly monitor the safety and give proper disposal in the course of treatment. |