Статья

Report: The results of the IPH T peptide complex clinical study

The IPH T peptide complex contains a mixture of low-molecular peptides with a molecular weight of up to 5,000 Da, produced by hydrolysis and enzymolysis with further selection of the necessary short peptide by passing the mass through nano-membranes corresponding to the configuration of the short IPH T peptide.

Experimental studies have shown that peptides have a tissue-specific effect on the cells of those tissues to which they are complementary. The peptide complex containing short peptides IPH T regulates the metabolism’ processes inside the immune system’s cells, restores impaired immunological reactivity, and stimulates regeneration processes in case of their suppression. This allows us to assume the effectiveness of using the peptide complex with short peptides to restore the function of the immune system in various purulent and inflammatory, and other diseases characterized by the suppression of the immune status of patients.

Well known that various factors of physical, chemical and biological nature, depending on the duration or intensity of their impact on the human body, can lead to the depletion of adaptive and compensatory mechanisms and being a cause of deep violations in various parts of the immune defense system (2, 3).

Pathological disorders in the immune system usually contribute to prolonged course of the main disease with a tendency to relapses, a decrease in the body’s resistance to infection and the development of severe complications.

Immunomodulators of various origins are considered among the means that contribute to the restoration of immunological reactivity: enzyme medicines, bacterial polysaccharides, yeast polysaccharides, vaccines, nucleic acid medicines, purine and pyrimidine derivatives (1, 2).

Clinical testing was conducted with patients exposed to long-term exposure of ionizing radiation low doses, including cancer patients after radiation and chemotherapy.

The main group consisted of 40 patients (20 men, 20 women) who received from 50 mg to 250 mg of the peptide complex by 3 times a day before meals for 21 days in addition to conventional treatment methods. The dosages were set depending on the severity of immune status disorders. Patients in the control group received only common medications. The age of patients in both groups ranged from 35 to 65 years. The division of patients by nosological forms, gender, and age is presented in table 1.

Research result

The effectiveness of the peptide complex was evaluated by the dynamics of patients ‘ complaints and a number of objective indicators: General clinical blood and urine testing, immunological examination of peripheral blood (the number of T — and B-lymphocytes was determined by immunofluorescence with monoclonal antibodies obtained to the differentiation antigens of CD3, CD4, CD8, CD20 lymphocytes; the content of immunoglobulins of various classes was determined by radial immunodiffusion in a gel according to Mancini technique; functional t — lymphocyte activity was determined by the inhibition’s reaction of lymphocyte migration (IRLM) with Concanavalin A).

Tests have shown that 90 % of people living in an ecologically unfavorable territory have violations in the immune status, which are manifested in a decreased number of CD3+, CD4+cells, with a slight increase of lymphocytes with the CD8+ phenotype, which indicates the level of immunoreactivity decrease (CD4+/CD8+). The results of inhibition’s reactions of lymphocyte migration (IRLM) with Concanavalin A characterize a decrease in the functional activity of T-lymphocytes (mainly CD8+, i.e. T-suppressors/killers). The content of CD20+cells representing a subpopulation of B lymphocytes did not differ significantly from normal indicators, but, at the same time, there was an increase in the number of immunoglobulins M and G in the blood serum (table 2).

It should be noted that the quantitative indicators of CD3+ and CD4+cells are characteristic of the lower limits of physiological fluctuations in their number in patients of this age, which may indicate exhaustion and premature of the immune system aging. As a rule, patients with secondary immunodeficiency had a pronounced asthenic syndrome and significant changes in the cardiovascular system.

 

The results of the research strongly suggest that the peptide complex IPH T is an effective tool for correcting secondary immunodeficiency developing in response to extreme factors. The use of the medicine in combination with symptomatic agents made it possible to normalize the disturbed immune system indicators in 75 % of cases.

As follows from the data, the greatest effect of the application was observed in relation to subpopulations of T-lymphocytes and their functional activity (a significant increase in the content of CD3+ and CD4+-lymphocytes, normalization of the CD4+/CD8+ratio). A less distinct reaction occurred on the part of the b-immune system, probably due to its greater conservativeness.

After the course of treatment, patients who received small ionizing radiation doses noted a significant improvement in their General state and a decrease in the severity of asthenic syndrome, which always accompanies secondary immunodeficiency.

In patients with cancer after radiation therapy and chemotherapy, there was a faster normalization of immunological indicators compared to the control group, which led to an improvement in overall health and a decrease in the frequency of complications. It is noteworthy that patients in the main group were able to undergo radiation therapy and chemotherapy more easily, and all patients were able to complete the entire course of radiation therapy (79% in the control group).

Conclusion

Clinical trials have shown that the peptide complex IPH T contributes to the normalization of cellular immunity indicators, stimulates tissue regeneration processes in case of their suppression, does not cause side effects, complications and medicine dependence, and can be used for therapeutic and prevention purposes in combination with any means of symptomatic and pathogenetic therapy used to correct secondary immunodeficiency conditions (immunomodulators, adaptogens, vitamins, etc.).

The IPH T peptide complex is recommended for accelerating the recovery of immune system functions after infectious diseases, for prevention and stimulation of the immune system, especially during pandemics and high season of acute respiratory viral infection diseases, after radiation therapy and chemotherapy, when the body is exposed to various extreme factors, living in unfavorable environmental territories and stressful life situations, with weakened or absent immunity. It is also recommended for the elderly to maintain the functions of the entire immune system.

No side effects, complications, contraindications, or medicine dependence were detected during the clinical study.

Literature

  1. Drannik G.N., Grinevich Yu.A., Dizik G.M. Immunotropic drugs. — Kiev: The Health, 1994. — 288 p.
  2. Mashkovskiy M.D. Medicines: Handbook of pharmacotherapy for doctors: Volume 2. – Vilnius, 1993.
  3. Novikov V.S., Smirnov V.S. Immunophysiology of extreme conditions. – Saint-Petesbourg: The Science, 1995. — 172 p.
  4. Sachek M.G., Kosinets A.N., Adamenko G.P. Immunological aspects of surgical infection. — Vitebsk, 1994. — 140 p.