Growth hormone therapy with three dosage regimens in children with idiopathic short stature. European Study Group Participating Investigators.

Autor: Rekers-Mombarg LT; Department of Pediatrics of the University Hospital of Leiden, The Netherlands., Massa GG, Wit JM, Matranga AM, Buckler JM, Butenandt O, Chaussain JL, Frisch H, Leiberman E, Yturriaga R, Aarskog D, Chatelain PG, Colle M, Dacou-Voutetakis C, Delemarre-van de Waal HA, Girard F, Gosen JJ, Irle U, Jansen M, Jean R, Job JC, Kaar ML, Kollemann F, Lenko HL, Waelkens JJ, et. al.
Jazyk: angličtina
Zdroj: The Journal of pediatrics [J Pediatr] 1998 Mar; Vol. 132 (3 Pt 1), pp. 455-60.
DOI: 10.1016/s0022-3476(98)70020-4
Abstrakt: Objective: In children with idiopathic short stature (ISS) we studied the growth-promoting effect at 4 years of recombinant human growth hormone (rhGH) therapy in three dose regimens and evaluated whether increasing the dosage after the first year could prevent a decline in height velocity (HV).
Design: Included were 223 patients who were treated with subcutaneous administrations of rhGH 6 days per week. They were randomized to three groups: 3 IU/m2 body surface/day, 4.5 IU/m2/day, and 3 IU/m2/day during the first year and 4.5 IU/m2/day thereafter, corresponding with dosages of 0.2 and 0.3 mg/kg body weight/week, respectively. Growth was compared with a standard of 229 untreated children with ISS [ISS standard].
Results: During the first year of treatment HV almost doubled and was higher with 4.5 IU/m2 than with 3 IU/m2. In the second year HV no longer differed among the groups, but increasing the dosage slowed the rate of the fall of HV. During 4 years of therapy the height SD score for age increased by a mean (SD) of 2.5 (1.0) [ISS standards], or 1.2 (0.7) (British standards), bone age increased by 4.8 (1.3) years, and predicted adult height SD score increased by 1.5 (0.7). After 4 years the results of the group with 4.5 IU/m2 were slightly better than those of the other groups. When dropouts were included in the analysis (assuming a stable height SD score after discontinuation of rhGH therapy), height gain was still significant.
Conclusions: During 4 years of rhGH therapy, growth and final height prognosis improved, slightly more with 4.5 IU/m2 than with 3 IU/m2 or 3 to 4.5 IU/m2. However, bone age advanced on average 4.8 years during this period; therefore, any effect on final height will probably be modest.
Databáze: MEDLINE