Medication, reducing hematotoxicity of cytostatics

FIELD: medicine.

SUBSTANCE: invention relates to chemical and pharmaceutical industry, namely to creation of medication reducing hematotoxicity of cytostatics. As such medication, polysaccharides from leaves of coltsfoot (Tussilago farfara L.) are used.

EFFECT: medication extends arsenal of preparations increasing efficiency of chemical therapy by reducing henatotoxicity of cytostatics.

2 tbl

 

The invention relates to medicine, specifically to Oncology, and can be used to reduce hematotoxicity cytotoxic drugs in patients with malignant tumors.

Cytotoxic drugs have a damaging effect on healthy, actively updated tissues, particularly blood. Often this side effect of chemotherapy drugs is a limiting factor for further treatment, leads to the development of anemia, neutropenia in patients at risk of infection, decrease the effectiveness of therapy and quality of life of patients. Currently in clinical Oncology practice for the stimulation of erythropoiesis used recombinant erythropoetin (Eprex, Recormon), for the stimulation of leucopoiesis use growth factors (leykomaks, Neupogen) [1, 2].

Object of the invention is the expansion of the means of increasing the effectiveness of chemotherapy by reducing hematotoxicity cytotoxic drugs.

The problem is solved by the use of polysaccharides from the leaves mother and stepmother ordinary (Tussilago farfara L.) as a means of reducing the hematologic toxicity of the cytotoxic drugs.

It is known the use of leaves mother and stepmother in physical form (chopped, raw materials) as an expectorant and protivovospalitelnoe (broth) with diseases of the upper respiratory tract [1].

New in the present invention is that as a means of reducing the hematologic toxicity of the cytotoxic drugs, use of polysaccharides from the leaves mother and stepmother of the ordinary.

New properties of polysaccharides from the leaves mother and stepmother ordinary to reduce the hematologic toxicity of the cytotoxic drugs have been identified experimentally. The new properties are not derived explicitly from the prior art in this area are not evident for specialists and not found in the patent and medical literature. Offered as an invention tool can be used in clinical Oncology.

Based on the foregoing, it should be considered the present invention with the relevant conditions of patentability: Novelty", "Inventive step", "Industrial applicability".

The study was conducted on a three-month mice-female line C57B1/6 mass 19-20, as a model of malignant growth used hematogenous metastasises the Lewis lung carcinoma, human intramuscularly for 5 million tumor cells in the mouse. Animals were divided into following groups:

1. "Control" (n=5) mice treated daily for 11 days, 0.1 ml ampoule of water for injection intraperitoneally.

2. "Paclitaxel" (n=5) mice treated with paclitaxel at a dose of 20 mg/kg once 9 the ut of tumor development.

3. "Paclitaxel + polysaccharides mother-and-stepmother" (n=5) mice treated with paclitaxel at a dose of 20 mg/kg once intraperitoneally on day 9 of tumor development and polysaccharides mother and stepmother at a dose of 10 mg/kg, starting with 6 days of tumor development (11 injections).

At 4 and 7 days after administration of paclitaxel collected peripheral blood from the tail vein was determined by its performance on automated Hematology analyzer "Abacus" ("Diatron") in veterinary mode. Processing of the obtained results was performed using non-parametric criterion of Wilcoxon-Mann-Whitney. The differences were considered significant at P≤0,05 [3].

A single injection of paclitaxel to mice C57B 1/6 with Lewis lung carcinoma at a dose of 20 mg/kg for 4 days resulted in the following changes of peripheral blood: reduced number of red blood cells, hemoglobin concentration, hematocrit relative to the control (table 1). Restore these parameters to the reference level was only 7 days. Severe neutropenia (neutrophils was decreased under the action of cytostatic 5.3-fold relative to control) was observed at 4 days after paclitaxel and persisted up to 7 days.

If the cytostatic combined with the introduction of polysaccharides mother-and-stepmother, such factors as the concentration of hemoglobin, number of erythrocytes and hematocrit restore what was aliwalas and has reached level control values to 4 days of observation. Neutropenia induced by paclitaxel, at 4 days after injection was observed in the group of combined treatment, but for 7 days in mice, which in addition to the cytostatic underwent a course of treatment with polysaccharides mother-and-stepmother ordinary, the number of neutrophils was significantly increased (2.7 times) and was superior to the one used for treated only with paclitaxel mice (table 1).

The experimental studies of the corrective properties of polysaccharides leaves mother and stepmother ordinary in respect of neutrophils compared with a known stimulator of granulocytopoiesis the Neupogen was conducted in mice-female line C57B 1/6 weight 19-20 g age 3 months. The Lewis lung carcinoma transplanted intramuscularly for 5 million tumor cells in the mouse. All mice with Lewis lung carcinoma were divided into groups:

1. "Control" (n=5) mice treated daily for 12 days 0.1 ml ampoule of water for injection intraperitoneally.

2. "Paclitaxel" (n=5) mice treated with paclitaxel at a dose of 32 mg/kg once on day 8 of tumor development.

3. "Paclitaxel + polysaccharides mother-and-stepmother" (n=5) mice treated with paclitaxel single dose of 32 mg/kg intraperitoneally for 8 days of tumor development and polysaccharides mother and stepmother at a dose of 20 mg/kg, starting with 6 days of tumor development (12 injections).

4. "Paclitaxel + Neupogen" (n=5) mice treated with paclitaxel at a dose of 32 m is/kg once intraperitoneally for 8 days of tumor development and Neupogen dose of 30 mg/kg in 5% glucose solution subcutaneously 5 injections starting from the next day after the administration of paclitaxel. At 4 and 7 days after administration of paclitaxel in mice from the tail vein was collected peripheral blood and count the total number of leukocytes and leukocyte common methods of [4].

When using paclitaxel at a dose of 32 mg/kg (table 2) in a single mode in mice with tumors at 4 days after administration of cytostatic leukopenia was observed, the number of leukocytes decreased 2.0 times (P≤0,01) relative to untreated mice. In the same period in animals with tumors treated with paclitaxel, the absolute number of neutrophils fell 15.5-fold (P≤0.01) compared with the control group. To 7 days after administration of paclitaxel in mice was observed recovery total leukocyte count up to control level. However, in this period the number of neutrophilic granulocytes did not reach baseline values and was significantly lower than the control level (1.3 times). If treatment with cytostatic added polysaccharides mother-and-stepmother ordinary, the number of segmented neutrophils already for 4 days increased 4.0-fold (P≤0.01)and by 7 days exceeded 1.9 times (P≤0,01) se in the group treated only cytostatic mice. Although the effect of Neupogen in respect of leukocytes was more pronounced, it is worth noting that the polysaccharides mother-and-stepmother ordinary did not cause the excessive increase in the number of white blood cells (unlike Neupogen), the effect of polysaccharides was sufficient to achieve a physiological norms and to protect the body against the development of infections and complications associated with oppression under the influence of paclitaxel.

Thus, the hematologic toxicity of paclitaxel in the experiment on mice with Lewis lung carcinoma decreased when combined with the use of polysaccharides leaves mother and stepmother of the ordinary.

Polysaccharides from the leaves mother and stepmother ordinary are promising in terms of creation on their basis of drug-correctors cyto-static treatment.

Literature

1. Mashkovsky PPM Medicines. - 15 ed., M: RIA "New wave", 2008. - 1206 S.

2. Pharmacology: a textbook. - 10th edition. - M.: GEOTAR - Media, 2008. - 752 S.

3. Gubler E.V. Computational methods of analysis and recognition of pathological processes. - L.: Medicine, 1978. - 193 C.

4. Goldberg ED, Digi A.M., Shah V.P. Methods of tissue culture in Hematology. - Tomsk: Publishing house of Tomsk University, 1992 - 264 C.

Table 1
The effect of polysaccharides from the leaves mother and stepmother are common in the peripheral blood in mice with Lewis lung carcinoma in a background of paclitaxel
GroupHemoglobin, g/lErythrocytes, 1012/lHematocrit, %The segmented neutrophils, 109/l
4 days7 days4 days7 days4 days7 days4 days7 days
1. Control145, 2mm±14,2USD 128.0±13,88,3±0,87,7±0,933,9±3,332,4±3,64,4±0,22,9±0,3
2. Paclitaxelto 113.4±4,0163,2±15,26,6±0,3110,2±1,027,3±1,543,4±4,50,8±0,12,2±0,3
1-2P≤0,051-2P<0,051-2P±0.011-2P≤0,05
3. Paclitaxel + polysaccharides mother-and-stepmotherof 149.0±12,0190,6±16,88,9±0,912,11±1,136,6±3,750,7±4,60,7±0,25,9±0,4
2-3P≤0,052-3P≤0,051-5≤0,052-5P≤0,051-5P≤0,052-3P≤0,01
Note. Hereinafter, before the significance level of P shows the number of compared groups

Table 2
The effect of polysaccharides from the leaves mother and stepmother ordinary and Neupogen in the number of neutrophils in the peripheral blood in mice with Lewis lung carcinoma in a background of paclitaxel
GroupThe total number of leukocytes, 109/lThe segmented neutrophils, 109/l
4 days7 days4 days 7 days
1. Control13,0±0,8the 15.6±1,13,1±0,44,8±0,3
2. Paclitaxel6,4±0,415,9±1,40,2±0,13,7±0,5
1-2P≤0,011-2P≤0,011-2P≤0,05
3. Paclitaxel + polysaccharides mother-and-stepmother6,5±0,517,5±2,190,8±0,37,1±1,1
2-3P≤0,052-3P≤0,05
4. Paclitaxel + Neupogen121±1,230,6±6,92,3±0,610,6±2,3
2-4P≤0,012-4P≤0,012-4P≤0,052-4P≤0,01

The use of polysaccharides from the leaves mother and stepmother ordinary (Tussilago farfara L.) as a means of reducing the hematologic toxicity of the cytotoxic drugs.



 

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