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Тимусамин - биорегулатор на тимуса

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THYMUSAMIN - IMMUNESYSTEM BIOREGULATOR

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BGN46.00
Product Code: Тимусамин - биорегулатор на тимуса

Thymusamin is recommended to facilitate restoration of im­mune functions after infectious diseases, radiation and chemo­therapy, exposure to various negative factors (including ioniz­ing and microwave radiation). Thymusamin is also recom­mended for the elderly patients to maintain immunity function.

Thymusamin is recommended to facilitate restoration of im­mune functions after infectious diseases, radiation and chemo­therapy, exposure to various negative factors (including ioniz­ing and microwave radiation). Thymusamin is also recom­mended for the elderly patients to maintain immunity function.

Maintain the physiological activation of immunity.

Used to strengthen the immune system.

Strengthen the immune system after radiotherapy and then chemotherapy.

Thymusamin administration is recommended 10-15minutes before meals,1—3capsules or tablets 2 — 3times a day for 10-15days.

Repeated course is recommended in 3 — 6months. No side-effects of Thymusamin have been registered.

Thymusamin is obtained from the thymus of cattle. It is a thymus-specific nucleoprotein complex acting selectively on immune system cells and promoting restoration of immune fun­ctions.

CLINICAL CHARACTERISTICS OF THE PATIENTS

 

117 patients exposed to long-term influence of ionizing irra­diation in low doses including cancer ones after radiation and chemotherapy were enrolled in the clinical trial. There also were traumatic patients with post-surgical purulent-inflammatory complications. Control groups consisted of 82 conventionally treated patients with similar pathology(21, 41, 51, 62).

Patient distribution by nosologic forms, gender and age

Diagnosis

Age (years)

Men

Woman

Total

Condition after irradiation with low ionizing radiation doses

22-35

15

8

23

Condition after radiation and chemotherapy   in the cancer patients

48-65

30

24

54

Crushed soft tissues wounds of upper and lower extremities

19-27

40

-

40

Total

 

85

32

 

117

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STUDY RESULTS

 

Thymusamin efficacy was assessed by the changes in the pa­tients' complaints, as well as clinical blood count and urina­lysis, immunoassay of peripheral blood (count of T- and B-lym-phocytes by immunofluorescence assay with monoclonal antibo­dies to differentiating antigens of CD3, CD4, CD8, CD20 lymphocytes; content of different class immunoglobulins by ra­dial immunodiffusion in gel according to Mancini; functional activity ofТ-lymphocytes by ConA-induced leukocyte migrati­on inhibition test); tissue enzyme activity examination.

To evaluate the objective criteria of the wound process in dynamics, the indices reflecting semiquantitative characteristics of separate cellular elements and structures of forming granula­ting tissue as well as activity of tissue enzymes were analysed.

The study showed that in 92% of the subjects living in eco­logically unsafe territory there are immune status disturbances manifested in decrease in CD3+, CD4+ counts along with mi­nor increase in lymphocytes with CD8+ phenotype indicating diminished immune reactivity (CD4+/CD8+). Results of the ConA-induced leukocyte migration inhibition test (LMIT) manifested lowered functional activity of T-lymphocytes (mainly, CD8+, i. e. T-suppressors/killers). The CD20+ countpresenting a subpopulation of B-lymphocytes did not signifi­cantly differ from the normal values but, at the same time, the increased quantity of immunoglobulins M and G in blood se­rum was noted


Thymusamininfluence on the cellular and humoral immunity indices in the persons exposed to low ionizing radiation doses

Indices

Before treatment

After treatment with conventional agents

After treatment with Thymusamin

Leukocytes, x109/l

5.2±0.3

5.3±0.2

5.4±0.2

Lymphocytes,%

x109/l

29.5±2.4

1.53±0.09

30.1 ±2.1

1.61 ±0.07

33.8+2.7

l.83±0.07

CD3+,%

x109/l

49.1 ±2.5

1.53±0.09

50.9±2.6

1.66±0.08

53.8±2.9*

1.83±0.07

CD4+,%

x109/l

28.3+2.1

0.43±0.03

31.2±2.4

0.49±0.04

35.1 ±2.7*

0.64±0.03*

 

 

 

 

CD8+,%

x109/l

26.7±1.9 0.40±0.04

26.0±1.8 0.43±0.04

25.8+1.6 0.47±0.05

 

 

 

 

CD4+/CD8+

1.1

1.2

1.4*

CD20+,%

x109/l

12.4±0.4

0.19±0.01

12.1 ±0.6

0.20±0.02

11.9±0.7

0.22±0.01

LMIT,%

87.5±6.4

77.4±5.2*

71.3±4.1*

IgM (g/1)

1.80+0.07

l.68±0.07

1.60±0.06

IgG (g/l)

15.9±1.1

15.7±1.4

15.4±1.9

IgA (g/l)

2.3±0.1

2.1 ±0.3

2.1 ±0.2

*P<0.05 — significant comparing to the indices before treatment.

 

The quantitative values of CD3+ and CD4+ counts should be noted to be characteristic for the lower limits of physiological fluctuations of their number in the persons of the specified age that, probably, reflects the immune system exhaustion and premature ageing.

As a rule, persons with secondary immunodeficiency state revealed marked asthenic syndrome and essential cardiovascu­lar changes.

The study results showed that Thymusamin was an effective agent for correction of secondary immunodeficiencies entailed by extreme factors. Thymusamin application in the complex with symptomatic medicines allowed to normalise the altered immune indices in 78% of the cases.

The obtained data demonstrated that the most prominent effect of the drug application was uponТ-lymphocyte sub-populations and their functional activity (significant increase in the CD3+ and CD4+ counts, restoration of a CD4+/CD8+ ratio). Less pronounced reaction noted on the part of the im­mune B-system was caused by its greater inertness.

After the applied Thymusamin treatment course the patients exposed to low ionizing radiation doses revealed considerable improvement in their general state and decrease of the asthenic syndrome severity that always accompanied secondary immuno­deficiencies.

In the patients after radiation and chemotherapy there were noted boosted restoration of immunity indices comparing to the control, that resulted the improved general state and di­minished incidence of complications.

Thymusamin administration in developing purulent-inflam­matory processes promoted improvement in the disease clinical course and reduction in the wound healing period in 81% of the patients.

The studied drug was applied starting from the 3th-5th day after a traumatic impact. The complex treatment with Thymu­samin was accompanied in most cases by significant increase in CD3+ and CD4+ counts, normalisation of a CD4+/CD8+ ratio and decrease in the ConA-induced leukocyte migration inhibi­tion test index.

Thymusamin influence on the cellular and humoral immunity indices in the traumatic patients with postoperative purulent-inflammatory

Indices

Before treatment

After treatment with conventional agents

After treatment with Thymusamin

Leukocytes, xl09/l

7.1±0.4

6.3±0.2

5.8±0.3

Lymphocytes,%

xl09/l

23.4±l.9

1.66±0.07

28.1 ±2.0*

1.77±0.05*

31.2±2.4*

1.81 ±0.06*

CD3\%

xl09/l

48.5±3.6

0.81 ±0.05

51.4±3.5

0.88±0.04

54.7±3.1*

0.99±0.06*

 

 

 

 

CD4+,%

xl09/l

29.4±2.1

0.49±0.03

32.7±2.6

0.59±0.01*

34.9±3.2

0.63±0.03*

CD8+,%

xl09/l

25.9±1.8

0.43±0.03

23.9±1.7

0.41 ±0.04

22.5±l.9

0.41 ±0.02

CD4+/CD8+

1.2

1.3

1.5*

CD20+,%

xl09/l

11.5±1.2

0.19±0.01

11.1±1.2

0.19±0.01

10.8±1.1

0.19±0.01

 

 

 

 

LMIT,%

79.6±5.2

74.1 ±4.1

7I.4±3.8*

lgM (g/I)

1.40±0.06

1.30±0.07

l.20±0.08

IgG (g/l)

13.7±1.1

13.0±1.2

ll.5±l.2

IgA (g/l)

2.1 ±0.2

2.0±0.2

2.0±0.1

*P<0.05—significant comparing to the indices before treatment.

The improved general state, alleviated intoxication signs, faster wound cleaning, boosted granulation and epithelisation were clinically registered.

Pronounced changes in clinical and immunity indices were already detected on the 5th —7th day from the treatment course onset, and the maximum effect was noted on the 13th— 16th day.

The study indicated that in the first inflammation phase on the 6th day an extensive necrosis in the tissues was observed

surrounded by a narrow rim of granulating tissue with scat­tered young fibroblasts and solitary histiocytes. In the prolifera­tion phase a broad layer of granulating tissue, in which many vessels and lymphoid cells were present, surrounded small-sized necrotic foci. Number of the histiocytes rose, and the macro­phages accumulated in the necrotic zones. The fibroblasts were of extended form with thin nuclei. In the cicatrisation phase the necrotic foci surrounded with the granulating tissue layer with mature fibroblasts were found. An interlayer of collagen fibers was observed amidst the fibroblasts. In interstitial sub­stance close to the necrotic zones precollagen fibers, fibro­blasts, histiocytes concentrated indicating resorbtional process and replacement of necrotised tissue by a young granulating one-Distinguishing attribute of the tissue reaction on Thymu-samin application consisted in the high activity of acid phos­phatase in the histiocytes at the proliferation phase (15th day). In the inconsiderable leukocytic infiltration foci, as well as in the vascular endothelium, alkaline phosphatase was highly ac­tive. At the cicatrisation phase high content of acid phos­phatase in the histiocytes and alkaline phosphatase in the leu­kocytes and vessels stabilised.

 

In the patients with purulent-inflammatory post-surgical complications, activation of the tissue enzymes indicating more intensive cellular metabolism in the tissues facilitating faster cleaning of the wound surface from the necrotised structures and epithelisation was objectively demonstrated. Observed sta­bilisation of the immune reactivity and regeneration activation allowed to reduce the terms of infected wound treatment.

The clinical study showed that Thymusamin facilitated res­toration of the cellular immunity, stimulated tissue regenera­tion in case of their suppression and did not cause any side-effects, complications and drug addiction; it can be adminis­tered with therapeutic preventive purposes combined with any other symptomatic or pathogenic agents used for the secon­dary immunodeficiency correction (such as immunomodulators, adaptogenic agents, vitamins, etc.).

Thymusamin influence on the enzyme activity development in wounded tissues of the traumatic patients

Patient groups

Monitoring terms (days)

Acid phosphatase

in the histiocytes (conv. units)

Alkaline phosphatase in the

leukocytes (conv. units)

Alkaline phosphatase in the vessels (conv. units)

Before treatment

6

3

3

2

 

15

4

4

4

 

21

4

4

3

 

28

3

5

3

 

 

 

 

 

After treatment

6

4

6*

4

with conventional

15

4

5

5

agents

21

5

4

4

 

28

5*

6

4

After treatment

6

5*

7*

6*

with Thymusamin

15

6*

6*

5

 

21

5

5

5*

 

28

5*

6

4

 

Chemical structure and nutritional value of Thymusamin:

Nutritional substances, %

Vitamins, mg/10 mg

Protein

63,8

Thiamin(B1)

0,08

Fats

13,7

Riboflavin(B2)

0,008

Carbohydrates

<0,01

Niacin(PP)

1,93

Ashes

9,12

Retinol(A)

0,024

 

à-Tocopherol(E)

0,108

Mineral substances, mg/10mg

Aminoacids, nmol/mg

Aluminium

0,262

Asparagine

401

Cobalt

0,0035

Threonine

237

Copper

0,0414

Serine

266

Iron

1,0665

Glutamine

595

Magnesium

8,835

Proline

253

Calcium

47,32

Glycine

431

Potassium

23,02

Alanine

425

Sodium

441,2

Valine

266

Manganese

0,0082

Methionine

23

Molybdenum

0,0044

Isoleucine

179

Phosphorus

217,85

Leucine

366

Sulfur

140,45

Tyrosine

105

Zinc

0,8203

Phenylalanine

122

Lead

0

Histidine

136

Cadmium

0

Lysine

417

 

Arginine

349

 

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