immunomodulator of new generation

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"LIASTEN" is prescribed as immunomodulating and haemoprotecting remedy at:

► the diseases accompanying with a secondary immunodeficiency and leukopenia;
► chemotherapy and radiotherapy of oncological patients and patients with leucosis;
► hronic radiation injuries;
► surgical treatment of oncological and other diseases of breast;
► complex antibacterial and antiviral therapies of sharp and chronic diseases of respiratory tract.

"LIASTEN" is also prescribed for treatment of patients with leukopenia of various origin.

Advantages of the preparation:

► stimulates the work of all basic cells of immune system (Т- and B-lymphocytes, macrophages);
► strengthens phagocytosis (absorption and digestion) of virus-infected, and tumoral cells, bacterial agents by the cells of immune system;
► strengthens the production of protective antibodies against alien substances;
► raises cytotoxinic properties of lymphocytes and other cells in relation to alien bacterial agents, to virus-infected and tumoral cells;
► stimulates haemo- and leucopoiesis (process of blood leukocytes and erythrocytes formation);
► reduces by-effects of chemotherapy and radiotherapy of tumours;
► improves blood circulation in tissues, improves healing of postoperative wounds;
► modulation of cytochrome P-450 system.

Now clinical research on application of LISTEN for patients with burns is completed.

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Results of clinical application of preparation LIASTEN in Ukraine on the basis of the chemotherapy and radiology departments of Vinnitsa, Khmelnitskiy, Zhitomir, Rivne and Lutsk regional oncological clinics

In total 195 people took part in research. (53 men and 142 women). The age of the examined was from 36 till 75 years. The basic contingent was the patients with breast cancer (38,5%), carcinoma of uterine cervix and vaginas (9,2%), cancer of the oral cavity (14,4%), lung cancer (12,3%), cancer of the thick bowels (9,2%).

All the patients had treatment concerning the basic disease in the form of radio and/or chemotherapy in full. Part of the patients had also surgical procedure concerning malignant neoplasms.

The application of the preparation promoted the improvement of the subjective state of the patients, better bearableness of chemo- and radio therapy. During the treatment with "Liasten" at 70-75 % of patients the expressiveness of the complaints connected to carrying out of antineoplastic therapy considerably decreased.

The parameters of blood leukogram during the researches made:

► before the beginning of treatment with the preparation-3,0±1,2*10/l;
► during the treatment with the preparation-3,6±1,0*109/l;
► after the treatment with "LIASTEN"-3,8+0,9*109/l.

During the application of the preparation only single cases (5,12 %) of by-effects as local reactions in the place of its injection and/or body temperature increase up to subfebrile figures were marked.

The clinical effect of the application of the preparation "Liasten" is recognized as excellent in 29,7% of cases, good - in 35,9% of supervisions, satisfactory - in 30,3% of cases, unsatisfactory - in 4,1% of supervisions.

Results of the application of the preparation "LIASTEN" in burns department of Vinnitsa regional hospital, Ukraine

"LIASTEN" was applied by 35 patients (basically the men in the age of 25-45 years) with burn disease of medium and heavy degree.

The application of the preparation promoted the improvement and speeding-up of healing of postoperative wounds, reduction of number of infectious complications that has caused the quantity decrease of application of antibacterial and infusion preparations. As a result of "Liasten" application the average stay of patients in bed in comparison with the representative control group was reduced on 7-10 days. The by-effects as easy local reactions were marked at 3 patients.

Results of application of the preparation "LIASTEN" in hepatitis department of Vinnitsa city infectious hospital, Ukraine

The preparation "LIASTEN" was applied by 25 patients (basically men in the age of 35-55 years) with virus hepatitis A and B or with liver cirrhosis.

As a result of "LIASTEN" application the patients with liver cirrhosis had no "scheduled" aggravations of disease within 6 months. At patients with the virus hepatitis A and B in comparison with representative control group the stay in a hospital was reduced on the average for 4-5 days. The by-effects as easy local reactions were marked at 2 patients.

Results of application of the preparation "LIASTEN" in day time hospital Vinnitsa city polyclinic №3, Ukraine

Preparation "LIASTEN" was applied by 15 patients with chronic and relapsing nonspecific diseases of respiratory apparatus. The basic contingent was made by men in the age of 24-37 years.

As a result of "LIASTEN" application at the patients the aggravation of chronic nonspecific diseases of respiratory apparatus was stopped faster (on the average for 3-4 days). Besides the duration of the relapse-free period increased on the average for 1-1,5 months. The by-effects as easy local reactions were marked at 2 patients, and body temperature rise-at 3 patients.

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Polycentral open researches of efficiency and safety of the preparation which had been carried out in 8 leading conducting scientific - practical institutions of Ukraine, have shown, that "LIASTEN":

► raises the general and recurrentless 5-years survival of patients with breast cancer;
► reduces frequency of postoperative complications, improves regeneration of postoperative wounds;
► reduces by-effects of chemotherapy and radiotherapy;
► stimulates leucopoiesis and haemopoiesis;
► stimulates phagocytosis, cellular and humoral immunity;
► reduces the general postoperative bed-day of the operated patients, reduces the days quantity of disability.

We give an example of one of such researches executed in Institute of experimental oncology and radiobiology by R.E.Kavetskogo of the National academy of sciences of Ukraine (Kiev).

The treatment of 81 patients with BC of I-IV stages was carried out with the use in the postoperative period of probiotic immunomodulator (PI), radiotherapy (RT) and/or various combinations of antineoplastic chemotherapy (ACT) (1-st group) (tab.1).

Table 1. Distribution of patients of the 1-st group depending on the method of special treatment and stage of BC
Method of special treatment + NI Stages of disease
I II III IV
PCТ 1 7 8 8
1 1 8 3
PCТ+RТ 2 12 18 12
Total 4(4,9%) 20(24,7%) 34(42%) 23(28,4%)

Middle age of patients - 50,2±1,1 year. RТ is carried out by the remote method on installation "Agate В" with the source of radiation 60Со in the mode of fractional fractionating on 2-2,5 gr daily on 2-4 fields. Average total nidal doze - 39,24±0,2 gr, average duration of the RT course - 19,6 ± 1,6 days. Polychemotherapy (PCТ) was carried out according to schemes CMF, АС,АР[16]. Average duration of the PCT course - 12,8±1,4 days.

To the 2-nd (control) group by the method of historical randomization 80 patients with BC are included, middle age of which - 49,9±1,4 years (tab.2).

Table 2. Distribution of the patients depending on the method of special treatment and stage of BC
Method of special treatment + NI Stages of disease
I II III IV
PCT 1 7 8 8
1 1 8 3
PCТ+RТ 2 11 18 12
Итого 4(5%) 19(23,79%) 34(42,5%) 23(28,75%)

At the combined treatment of patients of the 1-st group as supporting therapy was used the domestic preparation Blasten (new name "LIASTEN"), new natural immunomodulator which represents the mix of structural components of cellular walls and products of metabolism of Lactobacillus Delbrueckii (peptidoglycans, teichoic acids, nucleotides, peptides). The preparation in the form of lyophilized powder with exipient ("Enzim", Ukraine) was recommended by PHC MHC Ukraine in 1997 for medical application (the Report № 1 dd 30.01.97). Natural immunomodulator (NI) was injected in a doze of 0,002 g to the patient hypodermically into the area of an external surface of the top third of shoulder before the beginning of special treatment 1 time in 3-7 days (3-5 injections per course). Directly before the injection the contents of the vial were dissolved in 2 ml of isotonic solution of sodium chloride. At the use of NI other means of supporting therapy did not apply. Efficiency of NI at patients of both groups at all variants of treatment was estimated on change of quantity of leukocytes in peripheral blood. The control of quantity of leukocytes was carried out for a day prior to the beginning of treatment, on 7-8-th day at PCT and on 10-11-th day at RТ (the middle of treatment), and also in 5-7 days after the end of treatment.

At industrial release the cost of the preparation course, on our preliminary data, will be less than the cost of the import preparations (КСФ, blood preparations, etc.) and will make at the current rate about 10 US dollars. Statistical processing of the material is carried out by the method of average definition, attitudes of their estimated attributes, correlation coefficient and reliability of distinctions by t-criterion of Student.

The quantity of leukocytes at patients of the 1-st and 2-nd groups during treatment is resulted in tab. 3. Prior to the beginning of special treatment the quantity of leukocytes at patients of the 1-st group was authentic less, than at patients of the 2-nd group. To the middle of treatment there was an alignment of parameters at patients of the both groups at CT, RТ and RТ + PCТ (there are no statistically significant distinctions).

Table 3. Quantity of leukocytes (o 109/l) in peripheral blood of BC patients at combined or complex treatment (М±m)
Treatment method Group of patients Method of research
before treatment in the middle of treatment after treatment
PCT 1-я
2-я
p,
3.3 ±0,4
4.6 ± 0,3
р < 0,02
4,4 ± 0,5
3,5 ± 0,2
р>0,05
4,7 ± 0,6
3,3 ± 0,2
р < 0,05
1-я
2-я
p,
3.0 ±0,3
5,0 ± 0,6
р<0,01
3,7±0,4
3,6±0,4
р>0,05
3,8 ± 0,6
3,2 ± 0,2
р > 0,05
PCТ+RТ 1-я
2-я
p,
3,9 ±0,2
6,0 ± 0,7
р<0,01
4,9 ± 0,3
4,7 ± 0.4
р > 0,05
4,2 ± 0,2
3,1 ± 0,2
р < 0,001
At all methods of treatment 1-я
2-я
p,
3.7 ±0.2
5,2 ± 0,3
р<0,0001
4,7 ± 0,2
4,0 ± 0,2
р < 0.02
4,3 ±0,2
3,2 ± 0,1
р<0,00001

Note: the1-st group is the group of patients with BC use in treatment NI; 2-ndgroup is the control group of patients with BC; р, - distinctions are statistically authentic at р- <0.05.

At the same time at the patients receiving NI without taking into account a method of special therapy, the quantity of leukocytes has statistically authentically exceeded those at the patients who were not receiving the preparation (р<0,02).

By the end of treatment, in comparison with the beginning, the result was opposite. The quantity of leukocytes at patients of the 1-st group at all variants of treatment, except RТ, was authentic more, than at patients of the 2-nd group (р <0,05-У <0,00001). At the patients of the 1-st and 2-nd groups, who received RТ, between the parameters of quantity of leukocytes by the end of treatment the statistically significant distinctions was not revealed. The induced data show, that change of leukocytes quantity at patients of both groups has various character (fig. 1). Reduction of leukocytes quantity at patients of the 2-nd group and their increase at patients of the 1-st group during treatment in the second quarter of treatment form "scissors", and further up to the middle of treatment this dynamics (changes) has opposite character. At the end of treatment the quantity of leukocytes decreases at patients of the 2-nd group and increases at patients of the 1-st group, that testifies the leukostimulating function of NI at cumulation of cytotoxinic effect of special treatment.

Fig.1. Change of average quantity of leukocytes in peripheral blood at patients of the 1-st and 2-nd groups at treatment: 1-with NI; 2-without NI
Fig.2. Change of average quantity of leukocytes in peripheral blood at various kinds of special treatment at patients with BC in a combination with NI: 1-PCT; 2-RТ; 3-PCТ+RТ

At all variants of treatment at patients of the 1-st group (fig. 2) stable positive dynamics (changes) of leukocytes quantity is kept. Factor of correlation for the period "before treatment - the middle of treatment" - г = 0,973 (р <0,05), for the period "before treatment - after the end of treatment" - g=0,266 (р> 0,1).

At patients of the 2-nd group (fig.3) during the treatment the reduction of leukocytes quantity is marked.

Fig.3. Change of average quantity of leukocytes in peripheral blood at various kinds of special treatment at patients with BC without use of NI: 1-PCТ; 2-RТ; 3-PCТ+RТ

For the period "before treatment - the middle of treatment" the factor of correlation has made g=0,997 (р <0,001), and for the period "before treatment - after the end of treatment" - g =-0,866 (р> 0,1), that is at opposite dynamics of quantity of leukocytes in both groups to the middle of treatment the parameters in the 1-st group statistically authentically raise, and in the 2-nd group are statistically authentically reduce. For all period of treatment dynamics of parameters in the 1-st group - positive, and in the 2-nd - negative, that testifies to "avalanche" reduction of leukocytes quantity at patients of the 2-nd group at carrying out of various kinds of special treatment.

Thus leukostimulating effect of NI at all methods of special treatment exceeded the influence of cytotoxinic influence of antineoplastic remedies that is expressed in preservation of positive value of correlation factor even at reduction leukocytes quantity in the second half of treatment. Thus leukostimulating effect of IN at all methods of special treatment exceeded influence of cytotoxinic effect of antineoplastic remedies that is expressed in preservation of positive value of correlation factor even at reduction of leukocytes quantity in the second half of treatment.

Especially it is necessary to note return correlation dependence of parameters of leukocytes quantity at patients of both groups to the middle of treatment.

During this period g has made-0,797 (р<0,01) that is if in the 2-nd group cytotoxinic effect is proved by the reduction of leukocytes quantity, but on the background of NI occures their increase. It is necessary to take into account at planning of special treatment when there is a necessity of increase in radio or chemotherapeutic loading in the first half of treatment.

Application of NI at all methods of special treatment to the end of treatment promotes the increase of leukocytes quantity cytotoxinic action of RТ and PCТ. In case of special treatment without use of NI the quantity of leukocytes to the end of treatment is authentic less than reference values.

The complications, connected to application of the preparation, are not marked. Leukostimulating function of NI is combined with its economic availability. Average cost chemopreparations for course of treatment of BC has made 115 US dollars on 1 patient, and cost of the given preparation - 10 % from the all expenses spent by patients on one course of treatment. According to the literature unit weight of cost of supporting therapy in the all expenses for medicines makes more than 70%.