Method for treatment of patients with chronic hepatitis

FIELD: medicine, hepatology.

SUBSTANCE: invention relates to a method for treatment of chronic hepatitis. Method involves applying granocyte that is administrated every day intravenously in the dose 1-10 mcg/kg of patient weight per 24 h for 7 days, not above, in combination with conventional complex used in treatment of this disease. Method provides normalization of activity of blood enzymes that indicates the liver function recovery and improvement of the liver structure indices.

EFFECT: improved method for treatment.

2 ex

 

A method for the treatment of patients with chronic hepatitis relates to the field of medicine - immunology.

Chronic hepatitis is a group of liver disease caused by different reasons, with different degree of severity of hepatic cell necrosis and inflammation /infiltration dominated by lymphocytes and macrophages/ and flowing without improvement for at least 6 months. In recent years, a marked increase in the number of patients with chronic hepatitis is associated with an increase in the number of persons with injecting drug use, transfusion of blood and its components, dental manipulations and surgery, contact with patients of acute viral hepatitis, tattooing on the skin, promiscuous sexual contacts /for viral hepatitis b/, abortion. The main pathogenesis of chronic hepatitis allocated viral infection of hepatocytes by viruses, C. an important role in the development of chronic hepatitis is an autoimmune mechanism of the disease development, the defeat of hepatocytes drugs, chemicals, alcohol and its surrogates. In patients with chronic hepatitis histological examination of the liver during the evaluation of liver biopsies reveal stepped bridges or necrosis. Also in these patients is found vnutridolkovom or portal lymphohistiocytic the RNA infiltration. In alcoholic liver disease appears macrovesicular States /globular fatty liver/. In acute alcoholic hepatitis is characterized by leukocyte infiltration in centrolobular zone presents Pomorie-nuclear leukocytes, as well as portal mononuclear inflammation, leading to necrosis of hepatocytes. In chronic hepatitis dying liver cells, which perform their functions. Within 3-4 weeks after the development of necrosis of hepatocytes on the site of necrosis is formed scar tissue that replaces the dead hepatocytes. Over the next 2-3 months formed a dense scar. As the seal of the scar area of the liver shrink, shrink, cease to perform their functions. Developing decompensation of the liver. Gradually progresses to chronic hepatitis, cirrhosis of the liver, which leads to the formation of chronic renal failure and disability of the patient.

In medical practice known methods of treatment of patients with chronic hepatitis, for example, the following therapeutic action: the medication type hepatoprotectors /Essentiale, legal, Heptral, aminosteril, hepatorenal/, prescriptions, improves microcirculation of the liver tissue /solcoseryl, Actovegin, pentoxifylline/, the purpose of immunosuppressive farm the oncologic drugs /prednisolone, delagil, azathioprine/ to reduce the number immunocytologic complexes, and introduce a restriction of the consumption of spicy and fatty foods, see “a Brief guide to gastroenterology edited Ivashkin V.T., Komarova FI, Rapoport S.I., M., publishing house "LLC House of M-News", 2001, s-164.

The disadvantages of such a method of treatment of patients with chronic hepatitis are: implementation impact not etiologichesky factor of the disease, prescription drugs in this way are not able to recover the structure of the liver, therefore, this method of treatment is not effective enough.

The closest technical solution of the method of treatment of patients with chronic hepatitis is the solution specified in the guide for physicians Podymova S.D. "liver Disease", M, Medicine 1993, s-264. Therapeutic method of treatment for chronic hepatitis is the impact of a whole range of drugs, namely immunosuppressive effects by introducing prednisolone, azathioprine, intravenous amino acid mixtures by assigning hepatocele and aminosteril, prescriptions, normalizing the function of hepatocytes, antiviral drugs, immunosuppressant, immunomodulatory agents.

The disadvantages of such a method for the treatment of patients with chronic hepatitis are specified IU kamentsky drugs lead to restoration of function of liver cells, not restoring its structure, they are not able to influence etiologichesky factor, hepatitis b, C, D, E, at the same time treating them accompanied by a large number of side effects.

The technical result of the proposed method for the treatment of patients with chronic hepatitis b is to increase the effectiveness of treatment through rapid recovery of liver cells without formation of scar in it and stop the process of remodeling.

This result is achieved by the fact that in the treatment of patients with chronic hepatitis, which in General medicine with exposure auxiliary therapeutic agents, for example, polarizing blend, ascorbic acid, gemodez, trental, festal, Panagia, Riboxin, revive, ensitel, holenzim, diet №5, herbal medicine, physiotherapy, physical therapy, and hepatoprotective medicinal effect, introducing therapeutic agents of this group, for example, Heptral, gaalib, legalon, Essentiale, Kars, siripur, as well as in the introduction to the patient intravenously biological cytokine in the form of granulocyte coloneltimultima factor - Granocyte with dose 1-10 μg per kg of body weight of the patient per day, activating stem cells CD+SD-and controlling their number in peripheral blood, and the solution of Granocyte store during the day, and enter daily the main intravenous infusion over time to 40 minutes in duration treatment Granocyte not more than 7 days.

The essence of the invention is expressed in a set of key characteristics, sufficient to achieve provided by the invention a technical result.

Essential features of the invention, coinciding with the characteristics of the prototype are: - a General therapy with exposure auxiliary therapeutic agents, such as polarizing blend, ascorbic acid, gemodez, trental, festal, panagin, Riboxin, revive, enzistal, holenzim, diet №5, herbal medicine, physiotherapy, physiotherapy; B - hepatoprotective therapeutic effect by introduction of therapeutic drugs in this group, such as Heptral, gaalib, legalon, Essentiale, Kars, sonepar.

Salient features of the proposed method of treatment of chronic hepatitis are: - introduction to the patient intravenously biological cytokine in the form of granulocyte colonystimulating factor - Granocyte with a dose of 1-10 μg per 1 kg of body weight of the patient per day, which allows you to restore the microcirculation of tissue in the liver and proliferation of liver cells; the introduction of Granocyte certain dose activates stem cells CD+SD-by exercising control over their numbers in the peripheral blood of the patient that allows you to quickly restore liver cells without formation of rubtsovoizmenenne it and stop the remodelling process; D - solution Granocyte store during the day, and administered daily by intravenous infusion over time to 40 minutes in duration treatment Granocyte not more than 7 days, which allows you to save, to introduce high-quality, effective Granocyte and to achieve effective impact on liver cells.

In chronic hepatitis dying liver cells, which perform their functions. Within 3-4 weeks after the development of necrosis of hepatocytes on the site of necrosis is formed scar tissue that replaces the dead hepatocytes. Over the next 3-4 months formed a dense scar. As the seal of the scar area of the liver shrink, shrink, cease to perform their functions. Developing decompensation of the liver gradually progresses to chronic hepatitis, cirrhosis of the liver, which leads to the formation of chronic liver failure. In patients with chronic hepatitis histological examination of the liver during the evaluation of liver biopsies reveal stepped bridges or necrosis. Also in these patients is found vnutridolkovom or portal lymphohistiocytic infiltration. A method for the treatment of patients with chronic hepatitis b is carried out initially with the implementation of primary care, affecting auxiliary therapeutic agents, such as polarizing mixture is, ascorbic acid, gemodez, trental, festal, panagin, Riboxin, revive, enzistal, holenzim, diet №5, phytotherapy, physiotherapy /physical therapy/herbal medicine. Then spend hepatoprotective therapeutic effect, entering patient medical drugs from this group, such as: Heptral, gaalib, legalon, Essentiale, Kars, sonepar. Then a patient is injected biological cytokine in the form of granulocyte colony-stimulating factor - Granocyte with a dose of 1-10 mg/kg weight of the patient per day, activating the release of stem cells CD+SD-in the peripheral blood of the patient from his bone marrow using a triple combination of direct monoclonal antibodies 34FITC/SDRE/Sigs, controlling the number of table cells in the process of introducing Granocyte LeucoGATE/CD45/SD to highlight lymphocytic gate and isoptional control igG, FITC/Ig G2PE/CD45, and transforming them into full-fledged hepatocytes. The treatment is done strictly under the doctor's supervision. Granocyte is administered intravenously daily for 2-6 day from the date of examination of the patient. The maximum duration of daily administration of the drug should not be more than 40 minutes and not more than 7 days. When preparing the solution Granocyte 1 ml of water for injection in vials with solvent should be added in the flange with Granocyte /1 bottle - 263 µg/. actor of Granocyte diluted with a physiological solution. The total amount of liquid at the intravenous injection of 100 ml of the Prepared solution should be used as soon as possible and no more than during the days when stored at temperatures not less than 2°and not more than +25°With a daily dose intravenous drip infusion for a period of not more than 40 minutes. Thus, the use of granulocyte colony-stimulating factor - Granocyte certain dose and course of treatment of patients with chronic hepatitis leads to the activation and mobilization of stem cells CD+SD-in peripheral blood, controlling their number in the process of introducing Granocyte that leads to the restoration of the number of hepatocytes in the zone of necrosis. To place a deathly altered liver tissue does not form a scar, and a full functioning tissue that leads to rapid recovery of the patient and does not lead to disability. In this way was treated 5 patients. The drug is prohibited to enter with the increase in the number of blood leukocytes above 50-70×109L.

The use of the invention "Method of treatment of patients with chronic hepatitis" according to prototype and received technical result allows to achieve effective treatment through rapid recovery of liver cells without formation of scar it is stopping the process of remodeling. Using common medical therapy with known auxiliary therapeutic agents for the treatment of chronic hepatitis injected drugs hepatoprotective effects of this group of type Heptral, gaalib, legalon, Essentiale, Kars, sonepar and then intravenously administered biologically active cytokine in the form of granulocyte colonystimulating factor - Granocyte with a dose of 1-10 mg/kg of body weight/day, activating stem cells CD+SD-and controlling their number in peripheral blood during drip of Granocyte. These steps allow you to restore microcirculation tissue in the liver and proliferation of liver cells. Thus the solution of Granocyte store during the day, and enter daily for a period of time not more than 40 minutes in duration treatment Granocyte not more than 7 days. According to this method was treated 5 patients in hospital No. 20, St. Petersburg. Was restored biochemical and liver function the liver, normalizing the function of hepatocytes, preventing the formation of scar tissue at the site of necrosis or apoptosis and preventing the apoptosis of hepatocytes.

Epicrisis No. 375/03.

Example 1.

Patient HAK, 39 years old, live at Saint-Petersburg, street Budapest 45 / II corps, CV, was treated at therapeutic Department of the AI city hospital No. 20 20.01.03 on 11.02.03 diagnosed with:

Chronic persistent hepatitis. The acute phase.

Treatment: diet №5, polarizing blend, ascorbic acid, gemodez, Riboxin, panagin, Essentiale, gaalib, legal, enzistal, holenzim, reviewone, Granocyte, herbal medicine, FT, exercise therapy.

G-CSF Granocyte was introduced by the scheme:

23.01.03. - 66,8 million ME,/venous drip.

24.01.03. - 66,8 million ME,/venous drip.

25.01.03. - 66,8 million ME,/venous drip.

26.01.03. - 66,8 million ME,/venous drip.

27.01.03. - 66,8 million ME,/venous drip.

As a result of the treatment the patient's condition has improved.

The dynamics of changes in blood count
Index22.01.03.25.01.03.27.01.03.29.01.03.03.02.03.
Leukocytes5,819,528,516,75,2
Erythrocytes4,84,0a 4.95,15,5
Hemoglobin 128122126132130
Platelets210340355320300
The plasmic order has been revealed--2--
Young-121-
Stab6913145
Segmented6471747262
Lymphocytes211551018
Monocytes/td> 633211
Eosinophils31103
Basophils00011
Erythrocyte sedimentation rate352220158
Biochemical analysis of blood
IndicatorsNorma22.01.03.25.01.03.27.01.03.29.01.03.30.02.03.03.02.03.10.02.03
ACTup to 40%58444035312420
ALTup to 40% 112959265483822
Alkaline phosphataseto ME 280550490382260245212178
Urea1,2-7,06,14,2the 5.7the 3.83,1-of 5.4
Creatinine0,062-0,1320,1250,090,060,060,070,080,089
Cholesterol3.9 to 6.5 mmol/l4,354,88of 5.296,15,94,8a 4.9

 mmol/l       
About. protein65-85 g/l90,172,268,1---75,5
Mar. blood3.5-5.5 mmol/l5,55,25,15,8the 4.75,0-
Obvilious8,5-of 20.5 µmol/l64,852,944,328,125,718,115,5
Sodium142 mmol/l156142140141,6-135125,1
Potassium5 mmol/l4,84,274,354,2-4,65a 4.9
C-reactive proteinRef.+++++++++++++++
Prothrombin. Index87-105%12212011288789584

Urine analysis: (20.01.03.) dark yellow, cloudy, a specific weight of 1025, the reaction of the acid, bile pigments ++, protein - trace, glucose neg., leukocytes 8 in the field of view, mucus - 1, bacter and - 1.

Urine analysis: (07.02.03.) light yellow, transparent, specific weight of 1018, the reaction of the acid, bile pigments neg., protein neg., glucose neg., leukocytes 4-6 field of view, mucus - 0.

Dynamics of changes in the number of blood stem cells according to flow cytometry (study performed on a flow cytometer FACScan firm “Becton Dickinson” using a triple combination of direct monoclonal antibodies CD34FITC/CD38 PE/CD45 of Regs for determination of CD34+CD38 - cells, LeucoGATE (CD45/CD14) to highlight lymphocytic gate and isoptional control IgG1FITC/IgG2PE/CD45 (“Becton Dickinson”)

Indicators (%)20.01.03.24.01.03.29.01.03.
CD34+CD38-00,750,55
CD34+CD38+01,681,24

ECG: (20.01.03.) sinus rhythm with heart rate of 72 per minute. Moderate diffuse changes of a myocardium.

On radiographs of the thoracic cavity revealed no pathology (22.01.03.).

Dynamics ultrasound of the abdominal cavity
Indicators21.01.03.06.02.03.
LiverLiver diffuse sealed. The edge of the liver to 4.0 cm stands from under the edges of the ribs the OI arc. Liver at the edge of the costal arch.
Gall bladderThe gallbladder wall is sealed. In the gall Zamoskvorechie content.The gallbladder wall is sealed.

PancreasThere is the seal of the pancreas.Improvement structures in the tissue of the pancreas.

Epicrisis No. 344/03.

Example # 2

Patient CLI, 42 years old, living at the address Saint-Petersburg, Avenue Kim 11, CV, were treated in the medical ward of the city hospital №20 on 15.01.03 07.02.03 diagnosed with:

Chronic persistent hepatitis. The acute phase.

Treatment: diet №5, polarizing blend, ascorbic acid, Riboxin, panagin, Heptral, gaalib, Kars, siripur, festal, holenzim, multivitamins, trental, Granocyte, herbal medicine, FT, exercise therapy.

G-CSF Granocyte was introduced by the scheme:

21.01.03. - 66,8 million ME,/venous drip.

22.01.03. - 66,8 million ME,/venous drip.

23.01.03. - 66,8 million ME,/venous drip.

24.01.03. - 66,8 million ME,/venous drip.

25.01.03. - 66,8 million ME,/SNO drip.

As a result of the treatment the patient's condition has improved.

the dynamics of changes in blood count
Index17.01.03.21.01.03.23.01.03.26.01.03.30.01.03.
Leukocytesof 5.45,922,826,24,2
Erythrocytes4,554,44,85,24,95
Hemoglobin120124122130138
Platelets390350405420360
The plasmic order has been revealed--12-
Young--1 4-
Stab5412154
Segmented6268727465
Lymphocytes211910422
Monocytes74217
Eosinophils44203
Basophils11001
Erythrocyte sedimentation rate252820 1812
Biochemical analysis of blood
IndicatorsNorma17.01.0324.01.03.28.01..03.30.01.03.02.02.03.06.02.03.10.02.03
ACTup to 40%55524832281211
ALTup to 40%98757049403531
Alkaline phosphataseto ME 280450385290255230220180
Urea1,2-7,0to 6.585,67the 5.456,12--6,05
Creatinine0,062-0,132 0,1300,080,070,070,080,0950,101
Cholesterol3,9-6,55,284,125,28--4,054,1

About. protein65-85 g/l88,570,764,262,971,5-64,1
Sokrati3.5-5.5 mmol/l5,25,54,2--5,14,3
Obvilious8,5-of 20.5 µmol/l54,555,835,132,820,516,214,8
Sodium142 mmol/l148146145142140136138
Potassium5 mmol/lthe 4.74,8the 4.7---4,4
C-reactive proteinRef. +++++++++++++++++Ref.
Prothrombin. Index87-105%12911298-98-94

Urine analysis: (22.01.03.) dark yellow, cloudy, share - 1022, the reaction of the acid, bile pigments - +++, protein - trace, glucose neg., leukocytes 10 in the field of view, mucus - 1, bacteria - 1.

Urine analysis: (06.02.03.) light yellow, transparent, specific weight -1015, the reaction of the acid, bile pigments neg., protein neg., glucose neg., leukocytes 3-4 in eyeshot, mucus - 0.

Dynamics of changes in the number of blood stem cells according to flow cytometry (study performed on a flow picometre FACScan firm “Becton Dickinson” using a triple combination of direct monoclonal antibodies CD34FITC/CD38 PE/CD45 of Regs for determination of CD34+CD38 - cells, LeucoGATE (CD45/CD14) to highlight lymphocytic gate and isoptional control IgG1FITC/IgG2PE/CD45 (“Becton Dickinson”)

Indicators (%)23.01.03.26.01.03.29.01.03.
CD34+CD38-01,150,78
CD34+CD38+0,451,761,47

ECG: (20.0103.) sinus rhythm with heart rate of 68 per minute. Moderate diffuse changes of a myocardium. Incomplete blockade of the left bundle branch.

On radiographs of the thoracic cavity revealed no pathology (20.01.03.).

Dynamics ultrasound of the abdominal cavity
Indicators22.01.03.07.02.03.
LiverLiver diffuse sealed. The edge of the liver to 6.0 cm stands from under the edge of the costal arch.Liver at 1.0 cm stands from under the edge of the costal arch. Improving the structure of the liver tissue.
Gall bladderThe gallbladder wall is sealed. In the gall Zamoskvorechie content.The gallbladder wall is sealed.

PancreasThere is a compaction of the tissue of the pancreas.Improvement structures in the tissue of the pancreas.

A method for the treatment of patients with chronic hepatitis, is the impact of therapeutic tools such as polarizing blend, ascorbic acid, gemodez, trental, festal, panagin, Riboxin, revive, enzistal, holenzim, diet № 5, herbal medicine, physiotherapy, and hepatoprotective medicinal effect, introducing l the academic preparations of this group, for example, Heptral, gaalib, legalon, Essentiale, Kars, siripur, wherein the patient is also administered intravenously biological cytokine in the form of granulocyte colony-stimulating factor-Granocyte with a dose of 1-10 μg per 1 kg of body weight of the patient per day, activating stem cells CD 34+CD 38-and controlling their number in peripheral blood, and the solution of Granocyte store during the day, and administered daily by intravenous infusion over time up to 40 min in duration of treatment Granocyte not more than 7 days.



 

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FIELD: medicine, hepatology.

SUBSTANCE: invention relates to a method for treatment of chronic hepatitis. Method involves applying granocyte that is administrated every day intravenously in the dose 1-10 mcg/kg of patient weight per 24 h for 7 days, not above, in combination with conventional complex used in treatment of this disease. Method provides normalization of activity of blood enzymes that indicates the liver function recovery and improvement of the liver structure indices.

EFFECT: improved method for treatment.

2 ex

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