Autor: |
Dedov II; Endocrinology Research Centre., Shiryaeva TY; Endocrinology Research Centre., Fofanova OV; Endocrinology Research Centre., Bezlepkina ОВ; Endocrinology Research Centre., Nagayeva YV; Endocrinology Research Centre., Misharin AV; Endocrinology Research Centre., Peterkova VA; Endocrinology Research Centre. |
Jazyk: |
ruština |
Zdroj: |
Problemy endokrinologii [Probl Endokrinol (Mosk)] 2007 Apr 15; Vol. 53 (2), pp. 40-44. Date of Electronic Publication: 2007 Apr 15. |
DOI: |
10.14341/probl200753240-44 |
Abstrakt: |
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. |
Databáze: |
MEDLINE |
Externí odkaz: |
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