Effects of China-made recombinant human growth hormone on the treatment of growth hormone deficiency.
OBJECTIVE
To evaluate the therapeutic effect of China-made recombinant human growth hormone (r-hGH) in children with growth hormone deficiency (GHD) and to investigate the utilities of various biochemical parameters in GHD diagnosis and treatment.


METHODS
Our study comprises of 30 normal children and 71 GHD children treated with China-made r-hGH substitution therapy 0.1 IU x kg(-1) x d(-1) for 6 months. Serum insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), bone turnover markers (Ost, ICTP), and anti-growth hormone antibody (GHAb) were detected before and after r-hGH treatment.


RESULTS
After the first 3 and 6 months of treatment, growth velocities of GHD children were significantly increased (13.1 +/- 3.7 and 12.6 +/- 3.6 cm/year) compared with pretreatment values (2.9 +/- 0.8 cm/year, P < 0.01). GHD Children had obviously reduced serum levels of IGF-1, IGFBP-3, and bone turnover markers (Ost, ICTP) compared with normal controls (P < 0.01), and these biochemical parameters improved significantly after treatment (P < 0.01). Growth hormone antibodies were positive in 17 of 45 cases after treatment by binding capacity detection. The binding percentage of growth hormone antibody which was increased more than 30% after the treatment showed a negative correlation with growth velocity (P < 0.01).


CONCLUSIONS
(1) The growth stimulating effect and safety were confirmed in using China-made r-hGH in the treatment of GHD children for 6 months. (2) The measurements of serum IGF-1 and IGFBP-3 may serve as useful parameters in the diagnosis of GHD. (3) Serum Ost and ICTP are useful laboratory criteria for evaluating the effect of r-hGH therapy in the early stage. (4) It is necessary to monitor serum levels of GHAb during r-hGH therapy.
Jiang
Jing
J
Department of Pediatrics, Ruijin Hospital, Shanghai Second Medical University, Shanghai 200025. ykbiomed@sh163.net
Wang
Wei
W
Sun
Wen-xin
WX
Wang
Xiu-min
XM
Ni
Ji-hong
JH
Chen
Feng-sheng
FS
Wang
De-fen
DF
D000293:Adolescent; D001827:Body Height / Q000187:drug effects; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D002648:Child; D003094:Collagen / Q000097:blood; D024042:Collagen Type I; D005260:Female; D005500:Follow-Up Studies; D013006:Growth Hormone / Q000172:deficiency*; D019382:Human Growth Hormone / Q000627:therapeutic use*; D006801:Humans; D018972:Insulin-Like Growth Factor Binding Protein 3 / Q000097:blood; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008297:Male; D015675:Osteocalcin / Q000097:blood; D010455:Peptides / Q000097:blood; D011994:Recombinant Proteins / Q000627:therapeutic use
D024042:Collagen Type I; D018972:Insulin-Like Growth Factor Binding Protein 3; D010455:Peptides; D011994:Recombinant Proteins; C052929:collagen type I trimeric cross-linked peptide; D015675:Osteocalcin; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I; D013006:Growth Hormone; D003094:Collagen