Method of treating patients with oncological diseases or immune suppressions

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to oncology, and concerns treating the patients suffering oncological diseases by administering the preparations inducing active cellular immune stimulation. The preparations are administered in the form of lyophilised lysate of gram-positive enteric bacteria enclosed in gelatine capsules. That is combined with correcting intestinal dysbacteriosis, administering antioxidants, vitamins and minerals, as well as nutrient-enriched protein food, amino acid L-arginine, and pectin- and fibre-enriched vegetable food.

EFFECT: method provides higher clinical effectiveness of the patients suffering the oncological diseases with no side effects.

4 ex

 

The invention relates to medicine, in particular to Oncology and immunology.

Known cancer treatment and immunodepressed ready cytokines: interferons, interleukins (1. Minimum clinical recommendations of the European Society of Medical Oncology (ESMO) / Editors : Russian translation: professional Soulanges, CMN Dassow, Professor Nieprawadziwe. - M.: Publishing group of the Russian oncological scientific center named. Non Russian Academy of medical Sciences, 2010; 2. Guidelines for chemotherapy of neoplastic diseases. Edited Perevozchikova NI - 3rd ed., supplementary and processed): Practical medicine, 2011. - 512 S.).

However, passive immunotherapy ready cytokines has some significant drawbacks:

strong side effects, such as poisoning of the body, fever, cirrhosis of liver, adverse effects on the fetus and the immune status of the offspring;

in the patients body stops the production of cytokines own immune system, organs of the immune system atrophy, depression of immunity;

the duration of clinical effect is directly related to the total duration of treatment, as after the drug soon relapses of the disease;

to receive the benefits of further treatment is necessary to increase the dose of cytokines, which increases the toxic effect p is aparatow.

It is also known cancer treatment and immunodepressed active immunotherapy with vaccines Seu"containing lipopolysaccharide (Fighters A.G., Livland V.G. Treatment of dysbiosis: Food, medicines and biologically active additives. - SPb.: Publishing House "Neva"; M: OLMA-PRESS invest, 2003. - 384 S.).

The disadvantage of this treatment is that the vaccine has caused severe adverse reactions, primarily associated with increasing temperature, the poisoning of the body and the development of cirrhosis of the liver.

The task of the invention consists in stimulating the immune system of the patient using natural mechanisms developed in the course of human evolution, and maintenance of treatment without harmful side steps on his body.

The task is solved in that the treatment of patients with cancer and/or immunodepressed produce drugs that cause active cell immunostimulation, which according to the invention is in the form of lyophilized lysate gram-negative bacteria of the family intestinal. The key point is that these drugs should be placed in the capsule, preventing the absorption of the active substance in the upper intestine, for example in gelatin capsules. The effect of active immunotherapy quickly comes when nebolshaya, therefore, it should be applied at early stages of development of malignant tumors or after surgical removal of the tumor. Immunotherapy in this case focused on the prevention of recurrence and metastasis. In addition, after removal of tumors of the large decreases cancer intoxication, which strongly inhibited the immune system, and reduces the duration of active immunotherapy.

Thus, the proposed method has the following advantages:

1. therapeutic effect is achieved by the stimulation of the immune system of the patient using natural mechanisms developed in the course of human evolution.

2. There are no adverse reactions, which allows for long-term treatment as in-patient and outpatient settings.

3. Unlike known methods, the organs of the immune system not only atrophy, and contrast - enhanced, exaggerated.

4. No contraindications.

Example 1

The microorganisms of the family of the intestinal, the main representative of which is Esherichia coli, grown by the method of deep cultivation in a nutrient medium Endo for Escherichia coli (e.g., NPO "Nutrient medium", Makhachkala).

Sowing cultivated 18-24 hours at 36°C.

The culture fluid (QOL) with microorganisms subjected centres is Pirovano. Bacterial cells are lysed using a lytic enzyme trypsin (2.1 wt.%) for 4 hours at a temperature of +37°C.

The obtained enzyme lysate of bacterial cells subjected to freeze-drying in a drying apparatus for drying whey.

The resulting lyophilisate is mixed with sterile excipients: zeolite, hydrolyzed soy flour (POL), calcium stearate (CS).

The drug contains (wt.%): zeolite 70-80; hydrolysates of soy flour 15-20; calcium stearate 0.5 to 1.5; lytic enzymes of 0.05 to 3.5; lyophilized lysate of cells of microorganisms - the rest.

Under sterile conditions the drug in a hard gelatin enteric-soluble capsules, covered with acid-protective layer. The amount of the drug in the capsule must be such that the content of the lyophilisate in each capsule was 6 mg

Example 2

Patient W, 76 years of age.

on March 23, 2011 blood prostatespecific antigen (PSA): 8 ng/ml.

March 24, 2011 reception of oncourologist. When the finger examination of the prostate gland is determined by cartilage density formation of the left lobe of the prostate.

March 30, 2011, ultrasound, transrectal us. Prostate gland: Size 66×42×61 mm Volume gland 84,5 cm3. The capsule can be traced all over, smooth and clear. Echo fabrics mixed, heterogeneous structure. Isoechogenic node in the rights of the th Central zone 14 mm, in the left and the transition zone for 26 mm Present in both halves of 1-2 mm In the posterior peripheral zone of the left section 23×6×4 mm, reduced echogenicity, irregular shape, without clear contours with increased vascular pattern. Conclusion: the outer hyperplasia identifying hypoechoic area in the left peripheral zone.

March 31, 2011, needle biopsy of the prostate with 12 points under the control of transrectal us. Patologicheskoe conclusion: melkoatsinarnaya moderately differentiated prostatic carcinoma low grade, Gleason sum 5 points (2+3), on the background of BPH and chronic prostatitis.

April 1, 2011 enrollment of oncourologist. Diagnosis: prostate cancer stage III, group II, comorbidities - dishormone hypertrophy of prostate cancer and chronic prostatitis.

In the treatment of the proposed method, the patient took lyophilized lysate gram-negative bacteria of the family of intestinal dose of 6 mg, placed in gelatin capsules are prepared as described in example 1 for 3 months without a break, daily one capsule in the morning on an empty stomach. While traditional methods of treatment of oncological diseases (passive hormonal therapy, chemotherapy, radiation therapy, surgery, and other) were not applied.

Istace the AI 3-month treatment the patient underwent a medical examination.

August 18, 2011 the analysis of the PSA blood test and 6.6 ng/ml

August 19 2011, ultrasound, transrectal us. Prostate gland: Size 67×42×57 mm, Volume of a gland of an 80.2 cm3. The capsule can be traced throughout the stretch, smooth, clear. The echogenicity of the tissue is increased, the structure is heterogeneous. Exterior isoechogenic nodes to the right for 20 mm, left 31 mm. Present on a path of nodes, single cysts in the thick of nodes up to 3 mm In the posterior peripheral zone segment decreased echogenicity left 14×6×9 mm without clear contours, identifying vessels. The vascular pattern of the prostate is not modified. Seminal vesicles normal size, symmetrical structure is not changed. The lumen of the veins around the prostate was normal.

Given the presence of residual tumors of the prostate and the absence of any complications, it was decided to continue the treatment by the proposed method without interruption.

Control examination after 4.5 months of treatment.

on October 19, 2011 analysis of the PSA blood test and 6.7 ng/ml

November 1, 2011, ultrasound, transrectal us. Prostate spherical shape. Contours equal, precise. Length of 58 mm, a thickness of 47 mm, width 65 mm Volume 92,14 cm3. The capsule is not broken, irregularly thickened sealed. "Zonal differentiation" of the cancer is determined. The echogenicity of the parenchyma uneven. Structure p is estatales cancer: with the presence of Hypo - and hyperechoic areas, with hyperechoic inclusions in both lobes. In the left lobe mud lazerette nodal education 39 mm in diameter isoechogenic structure, with clear smooth contours, homogeneous, hypoechoic capsule surrounding education. Clearly visible hyperechoic surgical capsule. The peripheral part of the gland without focal changes irregular echogenicity. Along the prostatic part of the urethra and in periuretralnuu region lazerous hyperechoic inclusions. Peripatetically fiber is not changed, the normal echogenicity. Mode DRC - EDC pathological vascularization is not detected, the entities identified in previous surveys (with transrectal us from 3.03.2011, and, 19.08.2011), these areas are not detected. Conclusion: volumetric enlargement of the prostate (BPH).

Mood, sleep and appetite of the patient after treatment, the proposed method has improved. Before treatment experienced lack of energy, constant fatigue and was getting tired easily at the slightest exertion.

Blood counts after treatment has improved, the number of leukocytes WBC (overall immunity) increased to 4.81·109/l to 6,88·109/l, monocytes MONO (indicator of cell-mediated immunity) from 7.85% to 10.6%.

Indicators of liver function tests consistently good.

The beginning of the treatmentThe end of the treatment
ALT26UI29UI
AST29UI27UI
Timol0,6 ED0,4 ED

November 2, 2011 reception of oncourologist. Diagnosis: prostate cancer stage III, group III, comorbidities - dishormone hypertrophy of prostate cancer and chronic prostatitis.

The treatment offered by way stimulates the production of anti-inflammatory and antitumor cytokines of the immune system of the body, and the organs of the immune system are amplified, exaggerated. Cytokines formed by its own immune system, no toxic effects.

Example 3

Patient F., 70 years. Diagnosis: chronic athlete's skin of the foot and nail, immunosuppression.

After treatment the patient of the proposed method over one month installed cure fungal diseases of the skin of the foot and nail. No relapse was observed during the year.

Blood counts after treatment has improved, the number of leukocytes WBC (overall immunity) increased from 3,62·109/l to 5,74·10 9/l, monocytes MONO (indicator of cell-mediated immunity) 7,05% to 8.6%.

Example 4

Patient, 64 years. Diagnosis: recurrent shingles - Herpes zoster, immunosuppression.

After treatment the patient of the proposed method within one month of relapses no more than one year.

Blood counts after treatment has improved, the number of leukocytes WBC (overall immunity) increased from 3,55·109/l to 6.81·109/l, monocytes MONO (indicator of cell-mediated immunity) of 6.25% to 8.31%.

Mandatory treatment approach is the following:

- correction of dysbacteriosis of the intestine to recover the intake of lipopolysaccharides (LPS) in the natural way;

- intake of antioxidants (vitamins E, A, C, beta-carotene) to save from destruction connections NO;

Inbox full of protein foods to ensure the intake of essential amino acids L-arginine, which is the starting material for formation of compounds of NO in the body;

- the diet should be rich in pectin and fiber (vegetables, fruits, bran cereals) to stimulate the development of the normal intestinal microflora;

acceptance of other vitamins and minerals to improve metabolic processes.

The proposed method is promising and harmless to about what ractice and treatment of cancer, immunosuppressive conditions, viral infections (e.g. herpes). The proposed method can be used in the treatment of patients with malignant tumors as monotherapy, with tumors of large size in the combined treatment (surgery and postoperative active immunotherapy), as well as immunosuppression, viral and fungal diseases.

A method of treating patients with cancer, including treatment with drugs that cause the active cell immunostimulation, characterized in that such drugs are in the form of lyophilized lysate gram-negative bacteria of the family of intestinal placed in gelatin capsules, and is correction of dysbiosis, intake of antioxidants and full of protein that contains the amino acid L-arginine, plant foods rich in pectin and fiber, and vitamins and minerals.



 

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