title: Linear growth response to recombinant human growth hormone in children with growth hormone deficiency.
abstract: BACKGROUND
  This study was to evaluate the efficacy, safety and immunogenicity of recombinant human growth hormone (rhGH) in treatment of children with growth hormone deficiency (GHD).
  
  
  METHODS
  We selected 15 children with GHD for a 12-month clinical trial and separated them into three groups with each 5 patients receiving one of the 3 tested rhGH (Saizen by Serono, Aubonne, Switzerland; Genotropin by KabiVitrum, Stockholm, Sweden and Humatrope by Eli Lilly, Indianapolis, USA).
  
  
  RESULTS
  In Saizen group, 3 boys and 2 girls with a mean chronological age (CA) of 10.6 +/- 1.7 yrs and bone age (BA) of 6.7 +/- 1.2 yrs, at dose of 0.2 IU/kg sc tiw, gained an average BA of 2.1 +/- 1.3 yrs. The mean height velocity (HV) increased from 3.7 +/- 1.2 to 11.1 +/- 3.3 cm/yr. The height standard deviation score (SDS) increased from -4.2 +/- 3.1 to -3.1 +/- 2.9. In Genotropin group, 2 boys and 3 girls with a mean CA of 9.2 +/- 2.3 yrs and BA of 5.6 +/- 2.1 yrs, at dose of 0.1 IU/kg sc qd, gained an average BA of 0.8 +/- 0.2 yr. The mean HV increased from 3.4 +/- 0.7 to 11.3 +/- 2.0 cm/yr. The height SDS increased from -4.0 +/- 0.5 to -2.7 +/- 0.7. In Humatrope group, 4 boys and 1 girl with a mean CA of 10.3 +/- 3.5 yrs and BA of 5.8 +/- 2.9 yrs, at dose of 0.1 IU/kg sc qd, gained at average BA of 0.8 +/- 0.7 yr. The mean HV increased from 4.0 +/- 1.3 to 9.4 +/- 1.9 cm2yr, and the height SDS increased from -2.9 +/- 0.7 to -2.2 +/- 1.0. Very low titers of anti-rhGH antibodies were noted only in two patients, one in Saizen group (titer = 1:10) and the other in Genotropin group (titer = 1:6). Their HV was not affected (Saizen: 13.3 cm/yr, Genotropin: 11.2 cm/yr). One patient evolved subclinical hypothyroidism whereas no side effect at all was noted in the rest of patients.
  
  
  CONCLUSIONS
  Three tested GH (Saizen, Genotropin, Humatrope) produced by recombinant DNA technology appear to make no significant difference in this clinical trial, and rhGH therapy is an effective and safe treatment for prepubertal GHD children.
authors.affiliation: Department of Medicine, Army 804 General Hospital, Taipei, Taiwan, R.O.C.
authors.forename: K C
authors.initials: KC
authors.lastname: Shih
authors.forename: L T
authors.initials: LT
authors.lastname: Ho
authors.forename: H F
authors.initials: HF
authors.lastname: Kuo
authors.forename: T C
authors.initials: TC
authors.lastname: Chang
authors.forename: P C
authors.initials: PC
authors.lastname: Liu
authors.forename: C K
authors.initials: CK
authors.lastname: Chen
authors.forename: C M
authors.initials: CM
authors.lastname: Tiu
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006128:Growth; D006130:Growth Disorders / Q000503:physiopathology / Q000628:therapy; D013006:Growth Hormone / Q000172:deficiency* / Q000627:therapeutic use*; D019382:Human Growth Hormone; D006801:Humans; D008297:Male; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D011994:Recombinant Proteins; D019382:Human Growth Hormone; D013006:Growth Hormone