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Брошюра «Клинические исследования пептидных биорегуляторов» Электронная версия на английском языке — страница 22

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Vladonix® The biologically active food supplement VLADONIX® contains a complex of low molecular weight peptides with a molecular weight of up to 5000 Da, extracted from the thymus tissue of young ani- mals - calves up to 12 months of age or pigs. VLADONIX® is available in tablets or capsules with an active ingredient content of 10 mg. VLADONIX® peptides regulate metabolic processes in the cells of the immune system, restore im- paired immunological reactivity, and stimulate regeneration processes if they are suppressed. Experi- mental studies have shown that peptides have a tissue-specific effect on the cells of those tissues from which they are isolated. This suggests the effectiveness of VLADONIX® for restoring the function of the immune system in various pyoinflammatory and other diseases characterized by the suppression of the immune status of patients. We know that various physical, chemical, and biological factors, depending on the duration or intensity of their impact on the human body, can weaken adaptive and compensatory mechanisms and cause profound disorders in various links of the immune defense system (2, 3). Pathological disorders in the immune system usually contribute to a long course of the underlying disease with a tendency to relapse, a decrease in the body’s resistance to infection, and the develop- ment of severe complications. Among the means that contribute to the restoration of immunological reactivity, immunomodulators of various origins are considered: enzyme preparations (trypsin, lysozyme), bacterial polysaccharides (pyrogenal, prodigiosan), yeast polysaccharides (zymosan, glucans, propermil, dextrans), vaccines (BCG), nucleic acid medication ( sodium nucleinate), purine and pyrimidine derivatives, levamisole, diucifon, traditional medicine and many others (1, 2). Clinical trials of VLADONIX® took place from November 2005 to February 2006 at the Medical Cen- ter of the Saint Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences, in patients exposed to long-term influence of low doses of ionizing radiation, including oncological patients after radiation and chemotherapy. The primary group consisted of 42 patients (23 men, 19 women), who, in addition to conventional treatments, were prescribed VLADONIX® 1-3 capsules 2-3 times a day before meals for 15-20 days, depending on the severity of their immune status disorders. Patients in the control group received only general-purpose drugs. The age of patients in both groups ranged from 34 to 65 years. The dis- tribution of patients by nosological forms, sex, and age is presented in Table 1. Distribution of patients by nosological forms, sex and age Table 1 Diagnosis Age (years) Male Female Total Control Primary Control Primary Control Primary group group group group group group Condition after exposure to low 34-51 12 14 6 8 18 22 doses of ionizing radiation Condition after radiation and 45-65 7 8 9 12 16 20 chemotherapy in cancer patients Total 19 22 15 20 34 42 RESEARCH RESULTS VLADONIX® efficiency was assessed by the changes in patients’ complaints and by a number of objective indicators: general clinical examination of blood and urine, immunological examination of peripheral blood (the number of T- and B-lymphocytes was determined by the method of immuno- fluorescence with monoclonal antibodies obtained to the differentiation antigens of lymphocytes CD3, CD4, CD8, CD20; the content of immunoglobulins of various classes - by the method of radial immunodiffusion in gel according to Mancini; functional activity of T-lymphocytes - in the reaction of inhibition of lymphocyte migration (RTML) with ConA).

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