RESUMO
The effectiveness and safety of the new Russian drug Rastan® (recombinant human growth hormone) were evaluated in children with growth hormone deficiency (GHD) and Turner's syndrome (TS). An open-labeled clinical study of the drug was performed in 35 children with GHD or TS. The main efficacy criteria were growth changes and yearly calculated height velocity; the secondary criteria were changes in height SDS and IGF-1 and IGFBP-3 levels. Rastan® was subcutaneously injected daily for 6 months; the dose of the drug being 0.033 mg/kg in GHD and 0.05 mg/day in TS. All enrolled 35 patients completed the study. During the study, the patients' growth significantly increased in all the patients (P < 0 0001), in those with GHD (P < 0.0001) and TS (P < 0.0001). Height SDS statistically significantly increased in all the patients (P < 0.0001) and in the GHD (P < 0.0001) and TS (P < 0.0001) groups. Over 6 months of therapy, the average estimated height velocity was 12.4±3.76 cm/year. There were 2-3-fold increases in lower baseline IGF-1 and IGFBR levels. The advene reactions were mild and required no drug discontinuation. Rastan® was effective and well tolerated in patients with GHD or TS.
