Detailed Results of a Clinical Study of Vladonix

by:- KHAVINSON, Ph.D., Vladimir,  

 Vladonix® is a biologically active peptide bioregulator manufactured in form of capsules. It consists of complicated low molecular peptides with weight up to 10000 Da, cut off from thymus of young animals.

 According to experimental studies, peptides have tissue-specific action on the cells of the tissues from which they were cut off. Vladonix® peptides restore broken reactivity of immunological, regulate metabolism processes in the immune system cells, and enhance regeneration processes in case of their inhibition. Hence, it is possible to conclude that Vladinox® is productive in the restoration of immune system function at different decayed inflammatory and other diseases, defined by suppression of the immune status of the patients.

 Different environmental factors can result in deterioration of adaptation and compensatory mechanism and may lead to acute disorders of different segments of the immune protection system depending on intensity and duration of their influence on human organism. Restorative changes of the immune system come out in long-term course of basic disease with a readiness to recur, decline in resistance of the organism to severe complications and infections.

 Together with the drugs enhancing restoration of immunological reactivity are immuno-modulator drugs of different origin; preparations of enzyme (lysocim, tripsin), yeast polysaccharides (glucanes, zymosan, dextranes, prepermil) bacterial polysaccharides (prodigiosan, pyrogenal) vaccines (BCG), purine and pyrimidine derivatives, diucifon, levamisol, traditional medicine and nucleic acid preparations (sodium nuclienate) among others.

During the period from November 2003 to February 2004 the Medical Center of the Saint Petersburg Institute of Bioregulation and Gerontology was used to carry out clinical studies of Vladonix® in patients after long term low dose ionizing radiation influence, including oncological patients after radiation and chemotherapy.

 The clinical studies were conducted on 42 patients, which were 19 women and 23 men. The patients were given both Vladonix® and general-purpose drugs. The Vladonix® was given 1 to 3 capsules per os 2 to 3 times a day before meal for 15 to 20 days depending on a degree of immune status disturbances. Other patients in the control group were only given general-purpose drugs.

 The number of objective parameters and changes of the patients’ complaints were used to evaluate productivity of Vladinox®. These parameters include; broad clinical examination of urine and blood, immunological study of peripheral blood, immuno-fluorescence method completed the number of B- and T-lymphocytes with monoclonal antibodies to differentiation lymphocyte antigens COD, CD4, CD8, CD20; content of different classes immunoglobulin using a method of radical immune diffusion in a gel using the method of Mancini; functional activity of T lymphocytes using Leukocyte Migration Inhibition Test (LMIT) with ConA.

 The clinical tests done have indicated that many people living in the environmentally neglected area have immune status disorders in the form of decline in Cluster of Differentiation 3 (CD3+), Cluster of Differentiation 4 (CD4+) cells, and inadequate increase in the number of lymphocytes with Cluster of Differentiation (CD8+). Other immune status disorders in these people include increase in the number of lymphocytes with CD8+ phenotype, which is an indicator of decline of the reactivity level of the immune (CD4+ or CD8). A decrease in functional activity of T-lymphocytes mainly CD8+ like T killers was defined by the outcome of LMIT with ConA. Existing in subpopulation of B-lymphocytes and the number of CD20+ cells was not distinct from usual value but at the same time, there was growth in the number of some immuno-globulins in blood serum.

It is crucial to take into consideration that calculable signs of content of CD3+ and CD4+ cells are regular for lower limits of physiological changes of their number in patients of such age that is a possible indicator of immature ageing of the immune system. As a rule, people with secondary immune deficiency conditions have remarkable changes of cardiovascular system and severe asthenic syndrome.

 From the outcome of the test done it has proven the fact that Vladinox® is a productive method for correction of secondary immune deficiency as a response to influence of severe factors. In 78% of immune deficiency cases, the administration of Vladinox® together with symptomatic methods has helped normalize decomposed parameters of immune system.

 There was reliable increase in the number of CD3+ and CD4+ -lymphocytes, normalization of CD4+ or CD8+ portion as shown in the data given. The highest effect seen in administration of Vladinox® was identified in subpopulations of T-lymphocytes and in their functional activity. Higher conservativity influenced the less intense reaction noticed in B system.

The patients who have noticed decrease in intensity of asthenic syndrome and considerable improvement of general condition after the treatment course using Vladinox® always, aligned to secondary immune deficiency.

Improvement of general condition, reduction in the rate of complications and increased normalization of immunological indices were seen in oncological patients after radiation and chemotherapy. Patients of the basic group allowed radiation and chemotherapy better and were able to complete the whole course of treatment, which is the major thing that attracts attention in the report.

Vladonix® does not result in any side effects, drug dependence and complications. It stimulates tissue regeneration processes in case of their inhibition and boosts normalization of cellular immunity parameters, and can be used for treatment in the correction of secondary immune deficiency conditions like adaptogens, immune modulators, vitamins and more. It can also be used in treatment and prophylaxis in parallel with any means of symptomatic and pathogenetic therapy according outcome of the clinical studies.

Vladonix® should be taken 1 to 3 capsules per day for 20 to 30 days 2 to 3 times a day 10 to 15 minutes before meal. The clinical studies have shown that there are no complications, side effects, drug dependence or contradictions of Vladonix® therefore it is highly recommended for radiation and chemotherapy, and in acceleration of restoration of the immune system functions after an infectious disease. It has influence on the organism’s different extreme factors including UHF radiation and ionizing. Vladinox® is also advocated for use by elderly people for maintenance of functions of the immune system.