Clinical Study of the biologically active peptide bioregulator Vladonix

Vladonix®

A report of the results of clinical study of the biologically active peptide bioregulator of thymus origin:

The biologically active peptide bioregulator Vladonix® contains a complex of low-molecular peptides with molecular weight up to 10000 Da, isolated from thymus of young animals - calves aged up to 12 months.

Vladonix® is manufactured in the form of capsules with a content of active substances 10 mg.

Experimental studies have shown that the peptides possess tissue-specific action on the cells of the tissues from which they were isolated.  Vladonix® peptides regulate metabolism processes in the immune system cells, they restore the immunological reactivity that has been infringed; stimulate regeneration processes in case of their inhibition. Thus it is possible to extrapolate efficiency of Vladonix® for restoration of immune system function at different purulent-inflammatory and other diseases, characterized by suppression of the immune status of the patients.

It is well known, that various factors of physical, chemical and biological nature depending on duration and intensity of their influence on human organism, can result in deterioration of adaptation and compensatory mechanisms and may cause profound disorders of various segments of the immune protection system (2, 3).

Pathological changes of the immune system, as a rule, results in long-term course of basic disease with a tendency to relapses, reduction in resistance of the organism to infections and severe complications.

Among the drugs, promoting recovery of immunological reactivity, are immunomodulator drugs of various origin: enzyme preparations (tripsin, lysocim), bacterial polysaccharides (pyrogenal, prodigiosan), yeast polysaccharides (zymosan, glucanes, prepermil, dextranes), vaccines (BCG), nucleic acid preparations (sodium nucleinate), purine and pyrimidine derivatives, levamisol, diucifon, traditional medicine preparations and many others (1, 2).

The clinical studies of Vladonix® were carried out at the Medical Center of the Saint Petersburg Institute of Bioregulation and Gerontology in patients after long-term low-dose ionizing radiation influence, including oncological patients after radiation and chemotherapy during the period from November 2003 till February 2004.

The subjects of the clinical studies were 42 patients (23 men and 19 women) - apart from general purpose medicines they were taking Vladonix® per os before meal 1-3 capsules 2-3 times a day for 15-20 days depending on a degree of immune status disturbances.  The patients of the control group have been taking general purpose medicines only.

The age of patients has made from 34 up to 65 years. Distribution of the patients by clinical entities, sex and age is shown in the table 1.

 

Table 1

 

Distribution of the patients by clinical entities, sex and age

 

Diagnosis

Age

(years)

Men

Women

In total

control

group

main group

control group

main group

control group

main group

State after low-dose ionizing radiation influence

34-51

12

14

6

8

18

22

State after radiation and chemotherapy in oncological patients

45-65

7

8

9

12

16

20

In total

 

19

22

15

20

34

42

Examination results

Vladonix® efficiency was assessed by changes of the patients’ complaints and by the number of objective parameters: General clinical analysis of blood and urine, immunological study of peripheral blood (number of T- and B-lymphocytes was determined by immunofluorescence method with monoclonal antibodies to differentiation lymphocyte antigens CD3, CD4, CD8, CD20; content of various classes immunoglobulins - using a method of radial immune diffusion in a gel using Mancini method; functional activity of T-lymphocytes - using leukocyte migration inhibition test (LMIT) with  ConA).

The tests performed have shown, that 92 % of persons, living in the environmentally neglected territory, have immune status disorders in the form of decrease in the number of CD3+, CD4+cells, at insufficient increase in the number of lymphocytes with CD8+ phenotype, which is a sign of decrease of the immune reactivity level (CD4+/CD8+). The results of LMIT with ConA characterize a decrease in functional activity of T-lymphocytes (mostly CD8+, i.e. T-suppressors/killers). The number of CD20+-cells, being a subpopulation of B-lymphocytes, was not different from normal values, but at the same time there was an increase in the number of M and G immunoglobulins in blood serum (table 2).

It is important to note that quantitative indicators of content of CD3+ and CD4+ cells are typical for lower limits of physiological changes of their number in the patients of such age that is a possible sign of premature ageing of the immune system. As a rule people with secondary immune-deficiency condition has intense asthenic syndrome and considerable changes of cardiovascular system.

 

Table 2

 

Vladonix® influence of the cellular and humoral immunity parameters in patients, who have undergone low-dose ionizing radiation influence

 

Parameter

Before treatment

After treatment with general purpose medicines.

After treatment

using

Vladonix®

Leucocytes,  х109/l

5,0±0,2

5,4±0,1

5,6±0,1

Lymphocytes,  %

х109/l

26,2±2,6

1,51±0,08

31,4±2,4

1,64±0,05

35,1±2,1

1,87±0,05

CD3+, %

х109/l

 

46,5±2,3

1,53±0,09

 

51,9±2,2

1,65±0,07

 

55,7±2,6*

1,86±0,05*

CD4+, %

х109/l

28,5±2,8

0,41±0,01

30,8±2,1

0,49±0,07

34,6±2,0*

0,67±0,09*

CD8+, %

х109/l

 

26,4±1,5

0,43±0,05

 

25,7±1,6

0,42±0,03

 

24,9±1,8

0,46±0,07

CD4+/CD8+

 

1,1

 

1,2

 

1,4*

CD20+, %

х109/l

 

12,3±0,6

0,18±0,01

 

12,0±0,4

0,21±0,01

 

12,0±0,7

0,20±0,01

Leukocytemigrationinhibitiontest, %

88,1±5,4

76,2±4,8*

70,4±4,9*

IgM, (g/l)

1,82±0,06

1,72±0,05

1,66±0,06

IgG, (g/l)

15,7±1,3

15,6±1,6

15,3±1,7

IgА, (g/l)

2,2±0,1

2,0±0,1

2,1±0,3

* Р<0.05 – reliable in comparison the parameter before treatment

The results of the test performed provide strong evidence of the fact, that Vladonix® is an effective mean for correction of secondary immune deficiency, being a response to influence of extreme factors. Administration of Vladonix® together with symptomatic means has helped to normalize infringed parameters of immune system in 78 % of cases.

According to the data provided, the highest effect observed of Vladonix® administration was identified in subpopulations of T-lymphocytes and in their functional activity (reliable increase in the number of CD3+- and CD4+-lymphocytes, normalization of CD4+/CD8+ ratio). Less intense reaction was notices in B-system, probably, due to its higher conservativity.

After the treatment course using Vladonix®, the patients, which have noticed considerable improvement of general condition and decrease in intensity of asthenic syndrome, always parallel to secondary immune deficiency.

Oncological patients after radiation and chemotherapy had increased normalization of immunological indices, which resulted in improvement of general condition and decrease in the rate of complications.  What stands out in the report is the fact, that patients of the basic group tolerated radiation and chemotherapy better and was able to finish the whole course of treatment (control group – 79 %).

Conclusion

Clinical studies have shown, that Vladonix® promote normalization of cellular immunity parameters, stimulated tissue regeneration processes in case of their inhibition, does not result in any side effects, complications and drug dependence, and can be used for treatment and prophylaxis in parallel with any means of symptomatic and pathogenetic therapy, used for correction of secondary immune deficiency conditions (immune modulators, adaptogens, vitamins etc.).

Vladonix® is recommended for acceleration of restoration of the immune system functions after the infectious diseases, radiation and chemotherapy, influence on the organism of various extreme factors (including ionizing and UHF-radiation). It’s also recommended to elderly people for maintenance of the immune system function.

It is recommended to take Vladonix® per os 10-15 minutes before meal 1-3 capsules, 2-3 times a day for 20-30 days.

It may be desired to have one more course in 3-6 months.

The clinical study showed no side effects, complications, contraindications and drug dependence of Vladonix®.

References

1. Drannik G.N., Grinevich Y.A., Disik G.M. Immunotropic preparations. - Kiev Zdorov’ya, 1994. - 288 pages.

2. Mashkovsky M.D. Medicines: Pharmacotherapy for doctors, manual: 2 parts. - Vilnius: ZAO “Gamta”, 1993.

3. Novikov V.S., Smirnov V.S. Immune physiology of extreme conditions. - SPb.: Nauka, 1995. - 172 pages.

Schek M.G., Kosinets A.N., Adamenko G.P. Immunological aspects of surgical infection. - Vitebsk: B. i., 1994. -  140 pages.