[Effectiveness and safety of replacement treatment with the growth hormone drug Saizen in a new formulation].

The purpose of the study was to evaluate the efficacy of growth hormone (GH) drug Saizen in a new formulation (lyophilizate for the preparation of solution for injections as 8-mg vials in combination with bacteriostatic solvent in cartridges) in children with GH deficiency and to determine whether a Van.Click syringe-pen was handy for injection of Saizen in the new formulation. Thirty children (7 girb and 23 boys) were treated for 6 months. Ten patients had isolated GT deficiency; 18 patients had multiple adenohypophyseal hormonal deficiency; de Morsiau's syndrome was observed in 2 patients. The dose of the test drug was 0.033 mg/kg/day. During 6-month treatment, Slzen showed a good growth-stimulating effect: the mean growth rate was 11.15±0.71 cm/year; there was a 2-3-fold increase in the baseline low levels of insulin-like growth factor (ILGF-1) and ILGF-CB-3. Over 6 months of treatment, there was a significant decrease in the sum of 4 measured fat folds, which suggests a reduction in the body's adipose tissue. Significant changes were observed in biochemical parameters during the performed therapy: the decrease in the levels of total cholesterol and low-density lipoproteins, which suggests the antiatherogenic effect of GH therapy on lipid metabolism; a significant increase in the level of calcium and phosphorus, the activity of alkaline phosphatase, which is 3.5 times greater than the normal values, which indicate the acceleration of bone metabolic processes. According to the evaluation made, there were no unfavorable phenomena or significant deviation from the normal laboratory parameters, including glucose values. By and large, Sizen tolerance may be regarded as good and its treatment is safe. The use of the autoinjector for GH administration is handy and atraumatic to patients.