RU2293572C1 - Method for treatment of chronic viral hepatitis c of genotype-2 with moderate activity - Google Patents

Abstract

FIELD: medicine, hepatology, virology.

SUBSTANCE: invention relates to a method for treatment of chronic viral hepatitis C of genotype-2 with moderate activity. Method is carried out by every day parenteral administration of solutions containing a mixture of amino acids, nucleosides and enzyme. In the first day 0.2 ml of 0.01% solution of a solution containing a mixture of amino acids: lysine, arginine, asparagines, glutamic acid taken in the equal amounts is administrated; in the next day 0.2 ml of 0.02% solution containing a mixture of nucleosides: adenosine, inosine, amino acids, guanosine, and enzyme lysozyme also taken in equal amounts. Administration of solution is alternated every day during carrying out the treatment course and each 2 months break in administration of amino acids is carried out for 28-32 days. After 9-11 days of administration of proposed solutions method involves additional course of parenteral administration of interferon-α 2b in the dose 3 ml IU, 3 times per a week for 6 months. The total duration of treatment course is 6 months, 9 days - 6 months, 11 days. Method provides clinical remission and elimination of hepatitis virus and normalization of biochemical indices for 6 months after termination of treatment.

EFFECT: improved method of treatment.

2 tbl, 4 ex

Description

The invention relates to medicine, namely to hepatology, and can be used in the treatment of chronic viral hepatitis C genotype-2 with moderate activity.

Known methods for the treatment of liver diseases, including the use of various compounds with hepatoprotective effect. The main active components of known agents are various amino acids and their derivatives.

Known is an agent containing L-aspartic acid, L-arginine, and preferably sugar (e.g. sorbitol) as a targeted additive, used as a liver protective agent (FR 2305977 A1 (Otsuka Pharmaceutical Factory, Inc.), 12/03/76, A 61 K 31/195.)

Known mixtures containing L-amino acids and hydroxy and / or ketoacids used to treat liver and kidney diseases that prevent acidosis (US 456825A (Ajinomoto Co., Inc.), 06/24/86, A 61 K 31/195).

Derivatives of orotic acid (Hepatofalk drug) (FR 2494113 A 1 (Socoeto Anjnime Des Labjratoires Nogues), 05.21.82, A 61 K 31/195) are used as hepatoprotective agents in medical practice.

Folkamine is also widely known, consisting of amino acids: valine, leucine, isoleucine and used to treat hepatic encephalopathy in patients with viral hepatitis (Radchenko V.G., Shabrov A.V., Zinovieva E.N. Basics of clinical hepatology. St. Petersburg , "Dialect", 2005).

The disadvantage of these drugs containing amino acids and used to treat liver diseases is the lack of antiviral effect and insufficient anti-inflammatory effect.

To achieve antiviral and anti-inflammatory effects in the treatment of liver diseases, interferon preparations are widely used (Encyclopedia of Medicines. Russian Medicines Register, M., 2001, ed. 8, pp. 344-365).

The mechanism of action of interferons in chronic viral hepatitis is associated primarily with antiviral and immunomodulating effects. Thanks to this systemic effect, the integration of hepatitis C virus is achieved (reduction of adsorption, inhibition of deproteinization, induction of cell nucleases and proteases, stimulation of interferogenesis) with simultaneous stimulation of HLA of hepatocytes, amplification of killer cells and cytotoxic T-lymphocytes and production of memrane stabilizing antibodies.

Despite the high efficiency of interferon therapy, one cannot but pay attention to the development of side effects with the use of interferon, limiting the widespread use of interferon therapy in clinical practice and forcing the doctor to refuse further treatment in some cases. There is a group of side effects requiring immediate discontinuation of the drug (cytopenia and anaphylactic, psychogenic reactions, pulmonary edema, etc.) or a decrease in its dose (Radchenko V.G., Zinovieva E.N., Solovieva OM, etc. Side effects interferon therapy in the treatment of patients with chronic viral hepatitis // Actual issues of internal diseases. St. Petersburg, 2004, p.29-44).

As a prototype for the closest technical essence, we have chosen a method for treating patients with viral hepatitis C with interferon and ursodeoxycholic acid (Turyanov M.Kh., Fedoseyev M.A. Ursodeoxycholic acid. / South Russian Medical Journal, 2000, No. 5- 6).

The disadvantage of the prototype is the insufficiently high efficiency of treatment, which was confirmed by the participants of the conference-counselor held in Paris on February 7-28, 2002 ("Medical Department", 2003, No. 1 (5), p.138). The treatment method that we chose as a prototype also has side effects, such as cytopenic syndrome, psychogenic reactions, which is associated with the action of interferon (according to our own data).

The objective of the invention is to increase the effectiveness of the treatment of patients with viral hepatitis C genotype-2 with moderate activity due to improved clinical and laboratory parameters.

The problem is solved in that daily, a parenteral patient is injected with solutions containing a mixture of amino acids, nucleotides and an enzyme, on the first day 0.2 ml of a 0.01% solution containing a mixture of amino acids, consisting of lysine, arginine, asparagine, glutamic acid, is equal quantities, and the next day, 0.2 ml of a 0.02% solution containing a mixture of the nucleotides of adenosine and inosine, the amino acid guanosine, as well as the lysozyme enzyme in equal amounts is administered, and the solution is alternated daily throughout the course of treatment s. After 9-11 days of administration of solutions, treatment is carried out against the background of parenteral administration of interferon α 2b, prescribed in a dose of 3 ml ME 3 times a week. The course of treatment is 6 months and 9 days - 6 months and 11 days, and every 2 months they spend a break in the introduction of solutions in 28-32 days.

The method is as follows.

On the first day of treatment, a solution is prepared consisting of a mixture of amino acids: lysine, arginine, asparagine, glutamic acid in physiological saline at a concentration of 0.01% of each amino acid. On the first day the patient is injected subcutaneously with 0.2 ml of the prepared solution. The next day, a solution is prepared consisting of a mixture of the nucleotides of adenosine and inosine, the amino acid guanosine, as well as the lysozyme enzyme in physiological saline at a concentration of 0.02% of each ingredient. On this day, the patient is injected subcutaneously with 0.2 ml of the prepared solution. Subsequently, the introduction of these solutions is alternated daily. The introduction of solutions is carried out for 6 months and 9 days - 6 months and 11 days. Every 2 months of the introduction of solutions containing mixtures consisting of amino acids, nucleotides and an enzyme, take a monthly break. On the 9-11th day of the introduction of solutions, subcutaneous administration of interferon α 2b at a dose of 3 ml of ME 3 times a week for 6 months is added to therapy.

Distinctive essential features of the proposed method of treatment

- the introduction of interferon α 2b is carried out against the background of the introduction of solutions containing mixtures consisting of amino acids, nucleotides and an enzyme;

- the introduction of interferon α 2b begins on 9-11 days after the start of the introduction of solutions containing mixtures consisting of amino acids of the nucleotides and the enzyme;

- daily alternation of solutions: on the first day, 0.2 ml of a 0.01% solution containing a mixture consisting of amino acids: lysine, arginine, asparagine, glutamic acid is injected subcutaneously. The next day, 0.2 ml of a 0.02% solution is introduced containing a mixture consisting of the nucleotides of adenosine and inosine, the amino acid guanosine, as well as the lysozyme enzyme;

- every 2 months of the introduction of solutions containing mixtures of amino acids, nucleotides and an enzyme, take a monthly break;

- the course of treatment is 6 months and 9 days - 6 months and 11 days.

It is known that the liver plays a central role in ensuring the dynamic balance of proteins and the metabolism of amino acids in the body. Protein synthesis is closely related to the exchange of nucleic substances. Liver cells are able to synthesize all types of nucleic substances - low molecular weight polymers of DNA and RNA and low molecular weight nucleotides, which play an important role in the normal metabolism. In the liver cells there is a catabolism of over - and deaminated amino acids. Depending on the severity and nature of the liver disease, the amino acid composition of blood serum changes significantly, which significantly affects the course of the disease, the effectiveness of antiviral therapy.

Amino acids can be incorporated into signaling molecules consisting of a small (up to 8) amount of amino acids that penetrate the cell nucleus and initiate DNA and RNA for protein synthesis and expression of the corresponding genes.

Thus, influencing the expression of proliferation genes (for example, ki 67) or proapoptotic genes (the most significant p53, the B cl family), amino acids are directly involved in the basic processes of cell activity - proliferation and apoptosis. The necessary balance between these two processes may depend on the ratio of amino acids entering the cell.

For some amino acids, for example glutamic acid, receptors on the cell membrane are described. Other amino acids enter the cell using specialized transport systems - cationic and anionic.

Nucleotides are involved in the formation of codons encoding the sequence of amino acids in the synthesized proteins.

Lysine and arginine are the main amino acids, asparagine and glutamic acid are acidic. Lysine, arginine, asparagine and glutamic acid are amino acids with a charged side chain. Apparently, the properties of charged side chains are important for intercellular interactions. In addition, these amino acids are found with the greatest frequency in the repeating blocks of proteins.

Lysine - diaminocaproic acid refers to amino acids that contribute to the restoration of the plastic function of hepatocyte ribosomes. The main proteins (proteins, chromatin, ribosomal, fibrinogen) are rich in lysine.

The amino acid arginine has a protective effect in hypoxia, hypothermia; arginine activates Na-K-ATPase in the liver. The absence of exogenous arginine leads to the switching of the ornithine cycle to the synthesis of pyrimidine bases.

Amino acid asparagine stimulates protein synthesis, oxidative phosphorylation, increases the motility of the gastrointestinal tract due to the penetration of K + and Mg ++ ions into the intracellular space. Asparagine is widely involved in metabolic processes. Asparagine deamination occurs in the liver.

Glutamic acid is involved in the neutralization of ammonia, in protein and carbohydrate metabolism, stimulates oxidative processes, promotes the synthesis of acetylcholine, adenosine triphosphoric acid, and the transfer of potassium ions. Glutamic acid is a precursor in the synthesis of glutathione.

The nucleotide adenosine has a vasodilating, antiaggregatory, metabolic effect.

The inosine nucleotide has an antihypoxic, anabolic effect, improves blood supply and bone tissue regeneration.

The amino acid guanosine is a compound of guanine with ribose. Guanosine is a cyclic N-glycoside. It arises in the body as a product of nucleic acid catabolism. Guanosine can be considered as a precursor in the biosynthesis of nucleic acids.

Lysozyme is an enzyme that causes the lysis of many bacteria, "dissolving" their cell walls. The enzyme catalyzes the hydrolysis of glucoside bonds of the polysaccharide composition of the bacterial cell wall. Lysozyme is used to treat inflammatory diseases. Potentiates the anti-inflammatory effect of interferon α 2b.

Throughout the course of treatment, the introduction of interferon α 2b should be carried out against the background of the introduction of solutions consisting of a mixture of amino acids, nucleotides and an enzyme, that is, daily administration of solutions is necessary for the constant correction of metabolic processes carried out by the liver cells and disturbed by the introduction of interferon α 2b. Given the multidirectional effect of the amino acids, nucleotides and enzyme that make up the solutions, it is advisable to administer the solutions alternating daily. The introduction on the first day of treatment of a solution consisting of a mixture of amino acids: lysine, arginine, asparagine and glutamic acid has an anti-toxic effect, that is, it reduces the concentration of toxic substances, in particular ammonia, in the liver and blood serum. The next day, the introduction of a solution consisting of a mixture of the nucleotides of adenosine and inosine, the amino acid guanosine, as well as the lysozyme enzyme, has a plastic effect, i.e. improves the structure of the liver tissue.

Preliminary, that is, 9-11 days before the introduction of interferon α 2b, the introduction of solutions containing mixtures of amino acids, nucleotides and an enzyme is necessary to stimulate reparative processes in the tissues of the body, including the liver, by stimulating cell proliferation or its inhibition during apoptosis processes.

After a 2-month administration of solutions consisting of a mixture of amino acids, nucleotides and an enzyme, a break is carried out for 28-32 days, since 2 months is sufficient to replenish the structure and function of hepatocytes and correct metabolic disorders, which is confirmed by biochemical studies. At the same time, when canceling the introduction of solutions, interferon therapy in the form of monotherapy, which has side effects, continues, therefore, after 28-32 days, the introduction of solutions should be continued.

The generally accepted course of treatment with interferon is 6 months, but in the claimed method of treatment, the introduction of interferon α 2b begins on the 9th-11th day of the administration of solutions consisting of a mixture of amino acids, nucleotides and the enzyme, and therefore the course of treatment is 6 months 9 days - 6 months 11 days.

The set of distinctive essential features is new and allows to increase the effectiveness of the treatment of hepatitis C genotope-2 with moderate activity due to improved clinical and laboratory parameters.

As examples, we provide extracts from medical histories.

Example 1

And / b No. 328. Patient I., 25 years old.

Diagnosis: Chronic viral hepatitis C genotype-2 with moderate activity. On admission, he complained of weakness, dizziness, itching of the skin, yellowness of the skin. Sick for 2 years. Not treated.

On examination: satisfactory condition, icteric skin, pulse 78 beats / min, rhythmic. HELL 120/80 mm Hg Heart sounds are muffled, systolic murmur at the apex. The liver protrudes from under the edge of the costal arch by 4 cm, the spleen is not palpable.

In the analyzes: red blood cells 4.28 × 10 12 / L, hemoglobin 130 g / L, white blood cells 5.0 × 10 9 / L, platelets 210.0 × 10 9 / L, ESR 15 mm / hour, total protein 75.0 g / l, albumin 43%, gammaglobulins 22.0%, alkaline phosphatase 79.0 U / l, AcAT 1.58 mmol / l, AlAT 1.78 mmol / l, thymol sample 41.0 ALL, bilirubin 36 μmol / l , sugar 5.70 mmol / L, iron 15.0 μmol / L, HCV RNA (+++), heterotype-2.

During a morphological study of the liver, the lobular structure is preserved, hepatocytes are in a state of granular and focal hydropic and moderate fatty degeneration, polymorphism of nuclei. The portal tracts are moderately dilated with moderate lymphomacrophagal infiltration. Sinusoids are expanded, contain hyperplastic macrophages of IHA 9, fibrosis 1.

Treatment: diet No. 5, hepatene 1 capsule 2 times a day, alternating subcutaneous administration of 0.2 ml of a 0.01% solution consisting of a mixture of lysine, arginine, asparagine, glutamic acid - on the first day, the next day - 0, 2 ml of a 0.02% solution consisting of a mixture of adenosine, guanosine, inosine, lysozyme for 6 months and 9 days. Every 2 months of treatment, a break of 28 days was carried out. On the 9th day of the administration of amino acids, subcutaneous administration of interferon α 2b at a dose of 3 ml ME 3 times a week for 6 months was added.

A month after the start of therapy with interferon α 2b, carried out against the background of the introduction of solutions of amino acids, nucleotides and an enzyme, the patient's condition improved, weakness, dizziness, itching of the skin, and yellowness of the skin decreased.

In the analyzes: red blood cells 4.10 × 10 12 / l, hemoglobin 120 g / l, white blood cells 4.0 × 10 9 / l, platelets 190.0 × 10 9 / l, ESR 13 mm / h, total protein 76.0 g / l, albumin 44%, gammaglobulins 22.0%, alkaline phosphatase 55.0 U / l, AlAT 1.28 mmol / l, AcAT 1.35 mmol / l, thymol sample 39.0 ALL, bilirubin 33.0 mmol / l , sugar 5.60 mmol / L, iron 15.5 μmol / L, HCV RNA (+++), genotype-2.

After treatment, the condition is satisfactory, the liver is increased by 1 cm, the spleen is not palpable.

In the analyzes: red blood cells 4.05 × 10 12 / l, hemoglobin 125 g / l, white blood cells 4.5 × 10 9 / l, platelets 250.0 × 10 9 / l, ESR 8 mm / h, total protein 78.0 g / l, albumin 46%, gammaglobulins 20.0%, alkaline phosphatase 50.0 U / l, AlAT 0.70 mmol / l, AcAT 0.95 mmol / l, thymol sample 36.0 ALL, bilirubin 30.0, mmol / l, sugar 5.5 mmol / l, iron 14.0 μmol / l, HCV RNA (-).

In a morphological study of the liver: the architectonics of the organ is preserved, a decrease in the manifestations of granular, hydropic, fatty degeneration, portal tracts of normal size, their lymphomacrophage infiltration is significantly reduced. Sinusoids decreased in size IHA 4, fibrosis 1.

After treatment, clinical and virological remission lasts 6 months.

Example 2

And / b No. 570 Patient Yu., 27 years old.

Diagnosis: Chronic viral hepatitis C genotype-2 in the replication phase with moderate activity. Upon admission to the clinic, he complained of weakness, pain in the right hypochondrium, weight loss. Sick for about a year, not treated.

On examination: the condition is satisfactory, the skin and mucous membranes are icteric, the pulse is 76 beats / min, rhythmic. HELL 125/80 mm Hg Heart sounds are muffled, vasicular breathing. The liver protrudes from under the edge of the costal arch by 3 cm, the spleen is not palpable.

In the analyzes: red blood cells 4.0 × 10 12 / L, hemoglobin 110 g / L, white blood cells 4.3 × 10 9 / L, platelets 190.0 × 10 9 / L, ESR 16 mm / h, total protein 73.0 g / l, albumin 42%, gammaglobulins 23.0%, alkaline phosphatase 75.0 U / l, AlAT 1.85 mmol / l, AcAT 1.50 mmol / l, thymol sample 42.0 ALL, bilirubin 38.0 mmol / l, sugar 5.3 mmol / l, iron 17.0 μmol / l, HCV RNA (++++), heterotype-2.

Morphological examination of the liver: the architectonics is not disturbed, hepatocytes are in a state of granular and large droplet fatty degeneration, portal tracts are enlarged, infiltrated by lymphocytes, plasma cells, cell infiltration of the periportal region. Sinusoids are moderately dilated. IGA 10, fibrosis 1.

Treatment: diet No. 5, hepatene 1 capsule 2 times a day, alternating subcutaneous administration of 0.2 ml of a 0.01% solution consisting of a mixture of lysine, arginine, asparagine, glutamic acid - on the first day, the next day - 0, 2 ml of a 0.02% solution consisting of a mixture of adenosine, inosine, guanosine, lysozyme for 6 months and 10 days. After every 2 months of the introduction of solutions containing a mixture of amino acids, nucleotides and an enzyme, a break of 30 days was carried out. On the 10th day of the administration of amino acids, subcutaneous administration of interferon α 2b was added at a dose of 3 ml ME 3 times a week for 6 months.

A month after the start of therapy with interferon α 2b, carried out against the background of the introduction of solutions consisting of a mixture of amino acids, nucleotides and an enzyme, the patient's condition improved, weakness, pain in the right hypochondrium decreased.

In the analyzes: red blood cells 3.5 × 10 12 / l, hemoglobin 110 g / l, white blood cells 4.0 × 10 9 / l, platelets 170.0 × 10 9 / l, ESR 17 mm / hour, total protein 74.0 g / l, albumin 44%, gammaglobulins 22.0%, alkaline phosphatase 69.0 U / l, AlAT 1.60 mmol / l, AcAT 1.35 mmol / l, thymol sample 39.0 ALL_-, bilirubin 35.0 μmol / L, sugar 5.5 mmol / L, iron 16.0 μmol / L, HCV RNA (+++), heterotype-2.

After treatment - No complaints. The condition is satisfactory, the skin is clean, the liver is not palpable, the spleen is not determined.

In the analyzes: red blood cells 4.3 × 10 12 / L, hemoglobin 120 g / L, white blood cells 4.4 × 10 9 / L, platelets 210.0 × 10 9 / L, ESR 17 mm / h, total protein 75.0 g / l, albumin 48%, gammaglobulins 19.0%, alkaline phosphatase 40.0 U / l, AlAT 0.45 mmol / l, AcAT 0.40 mmol / l, thymol sample 25.0 ALL, bilirubin 15.0, μmol / L, sugar 5.1 mmol / L, iron 15.0 μmol / L, HCV RNA (-).

In a morphological study of the liver: the architectonics of the organ is not changed. Significantly reduced manifestations of granular and fatty degeneration. Portal tracts of normal size, decreased manifestations of inflammatory infiltration of portal tracts and periportal area. Sinusoids of normal sizes IGAZ, fibrosis 1.

After treatment, clinical, biochemical, virological remission lasts 6 months.

Example 3

And / b No. 114. Patient V., 31 years old

Diagnosis: Chronic viral hepatitis C genotype-2 in the replication phase with moderate activity.

At admission, he complained of weakness, yellowness of the skin, itching of the skin. Sick for about 3 years. Not treated. The condition is satisfactory, the skin is icteric. Pulse 76 beats in 1 min, rhythmic. HELL 125/80 mm Hg Heart sounds are muffled. The vesicular breathing, no wheezing. The abdomen is soft, the enlarged liver is palpated, the lower edge of which protrudes 3 cm from the costal arch, the spleen is not palpated.

In the analyzes: erythrocytes 4.3 × 10 12 / L, hemoglobin 115 g / L, white blood cells 5.6 × 10 9 / L, platelets 215.0 × 10 9 / L, ESR 20 mm / hour, total protein 78.0 g / l, albumin 42%, gammaglobulins 23.0%, alkaline phosphate 78.0 U / l, AlAT 1.80 mmol / l, AcAT 1.65 mmol / l, thymol sample 48.0 ALL, bilirubin 39.0 mmol / l, sugar 5.8 mmol / l, iron 17.5 μmol / l, HCV RNA (++++), heterotype-2.

Morphological study of the liver: architectonics preserved, granular and large-droplet fatty degeneration of hepatocytes, polymorphism of the nuclei, expansion of the portal tracts, moderate lymphomacrophagous infiltration of the tracts and periportal region. Sinusoids are dilated, contain an increased number of hyperplastic endotheliocytes and Kupffer cells IGA 10, fibrosis 1.

Treatment: diet No. 5, hepatene 1 capsule 2 times a day, alternating subcutaneous administration of amino acids - on the first day - the introduction of 0.2 ml of a 0.01% solution consisting of a mixture of lysine, arginine, asparagine, glutamic acid, the next day 0.2 ml of a 0.02% solution consisting of a mixture of adenosine, inosine, guanosine, lysozyme for 6 months and 11 days. After every 2 months of administration of amino acids, a break of 32 days was carried out. On the 11th day of the administration of amino acids, subcutaneous administration of interferon α 2b at a dose of 3 ml of ME 3 times a week for 6 months is added.

A month after the treatment with interferon α 2b, carried out against the background of the introduction of solutions containing a mixture of amino acids, nucleotides and an enzyme, the patient's condition improved, weakness, pain in the right hypochondrium decreased.

In the analyzes: erythrocytes 4.0 × 10 12 / L, hemoglobin 100 g / L, white blood cells 4.0 × 10 9 / L, platelets 170.0 × 10 9 / L, ESR 16.0 mm / hour, total protein 75 , 0 g / l, albumin 44%, gammaglobulins 22.0%, alkaline phosphatase 61.0 U / l, AlAT 1.40 mmol / l, AcAt 1.50 mmol / l, thymol sample 41.0 ALL_-, bilirubin 34 , 0 μmol / L, sugar 5.7 mmol / L, iron 17.0 μmol / L, HCV RNA (+++) genotype-2.

After treatment, no complaints. The condition is satisfactory, the skin is clean, the liver, spleen are not palpable.

In the analyzes: red blood cells 4.10 × 10 12 / L, hemoglobin 100 g / L, white blood cells 5.0 × 10 9 / L, platelets 200.0 × 10 9 / L, ESR 13 mm / hour, total protein 78.0 g / l, albumin 44%, gammaglobulins 22.0%, alkaline phosphatase 30.0 U / l, AlAT 1.80 mmol / l, AcAT 1.60 mmol / l, thymol sample 33.0 ALL, bilirubin 22.0, μmol / L, sugar 5.4 mmol / L, iron 16.0 μmol / L, HCV RNA (-).

Morphological examination of the liver: the structure of the organ is preserved. The manifestations of granular and fatty degeneration decreased. Portal tracts decreased in size, with their infiltration, as well as infiltration of the periportal region. Sinusoids of the normal sizes IGA 4, fibrosis 1.

After treatment, clinical and virological remission lasts 6 months.

Test case (prototype method)

And / b No. 677. Patient I., 30 years old.

Diagnosis: Chronic viral hepatitis C genotype-2 with moderate activity.

At admission, he complained of weakness, pain in the right hypochondrium, yellowness of the skin. Sick for about 2.5 years. Not treated.

The condition is satisfactory, the skin is icteric, pain on palpation in the right hypochondrium, pulse 76 beats. in 1 min, rhythmic. HELL 115/80 mm Hg Heart sounds are muffled. The vesicular breathing, no wheezing. The liver protrudes from under the costal arch by 3 cm, the spleen is not palpable.

In the analyzes: red blood cells 4.5 × 10 12 / L, hemoglobin 120 g / L, white blood cells 4.8 × 10 9 / L, platelets 190.0 × 10 9 / L, ESR 17 mm / hour, total protein 71.0 g / l, albumin 45%, gammaglobulins 23.0%, alkaline phosphatase 60.0 U / l, AlAT 1.90 mmol / l, AcAT 1.75 mmol / l, thymol sample 34.0 ALL, bilirubin 35.0 mmol / l, sugar 5.6 mmol / l, iron 18.0 μmol / l, HCV RNA (++++), heterotype-2.

Morphological examination of the liver: lobular preserved, granular small and large droplet fatty degeneration of hepatocytes, moderate polymorphism of the nuclei, portal tracts expanded with their lymphomacrophagal infiltration, as well as the periportal region. Sinusoids are moderately dilated, Kupffer cell hyperplasia of the sinusoidal lining, IHA 9, fibrosis 1.

Treatment: diet No. 5, hepatene 1 capsule 2 times a day, ureosan 2 capsules at night. The introduction of interferon α 2b subcutaneously in a dose of 3 ml of ME for 6 months.

One month after treatment with interferon α 2b, the patient's condition improved, weakness, and yellowness of the skin decreased.

In the analyzes: erythrocytes 4.0 × 10 12 / L, hemoglobin 105 g / L, white blood cells 3.0 × 10 9 / L, platelets 130.0 × 10 9 / L, ESR 16.0 mm / hour, total protein 70 , 0 g / l, albumin 44%, gammaglobulins 22.0%, alkaline phosphatase 55.0 U / l, AlAT 1.80 mmol / l, AcAT 1.60 mmol / l, thymol sample 33 ALL_-, bilirubin 30.0 μmol / L, sugar 5.8 mmol / L, iron 16.0 μmol / L, CV RNA (+++) genotype-2.

After treatment, the patient's condition improved. Remains heaviness in the right hypochondrium. The skin is clean, the edge of the liver is palpated 2 cm below the costal arch.

In the analyzes: red blood cells 4.10 × 10 12 / l, hemoglobin 105 g / l, white blood cells 3.6 × 10 9 / l, platelets 160.0 × 10 9 / l, ESR 14 mm / h, total protein 70.0 g / l, albumin 44%, gamma globulins 22.0%, alkaline phosphatase 56.0 U / D, AlAT 1.20 mmol / l, AcAT 1.10 mmol / l, thymol sample 35.0 ALL, bilirubin 30.0 , μmol / L, sugar 5.5 mmol / L, iron 15.0 μmol / L, HCV RNA (+) genotype-2.

Morphological examination of the liver: the structure of the liver tissue is preserved. The manifestations of granular and fatty degeneration decreased. Portal tracts decreased in size, moderate lymphomacrophagal infiltration of the portal ducts and periportal region. Sinusoids of the normal sizes IGA 6, fibrosis 1.

After treatment, clinical remission lasts 6 months.

The above extracts from case histories show that using the proposed method it is possible to treat patients with chronic hepatitis C genotype-2 with moderate activity with greater efficiency compared to the prototype method.

The method was tested on 10 patients. Results: after the end of the course of treatment, a decrease in ESR, an increase in the content of albumin, a decrease in the content of gammaglobulins, an indicator of thymol test, activity of AlAT, AcAT, bilirubin concentration, alkaline phosphatase activity, elimination of HCV RNA was observed. The achievement of clinical, biochemical and virological remission was established, in contrast to the prototype method, where only clinical remission was obtained against the background of ongoing therapy (data are presented in table 1). Data on the prototype method are presented in table 2.

The inventive method for the treatment of chronic viral hepatitis C genotype-2 with moderate activity in comparison with the prototype method increases the effectiveness of treatment by improving clinical and laboratory parameters.

Table 1 Clinical and laboratory parameters obtained using the claimed method of treatment Indicators Before treatment After treatment R Hemoglobin, g / l 120.0 ± 11.0 117.6 ± 10.0 > 0.05 Red blood cells × 10 ¹² / L 4.3 ± 0.35 4.25 ± 0.25 > 0.05 White blood cells × 10 ⁹ / L 5.1 ± 0.52 4.80 ± 0.47 > 0.05 Platelets × 10 ⁹ / L 210.0 ± 18.5 230.0 ± 17.0 > 0.05 ESR, mm / hour 18.6 ± 0.78 10.5 ± 0.84 <0.05 Alkaline phosphatase, E / l 78.3 ± 2.10 51.5 ± 2.58 <0.05 Total protein, g / l 76.0 ± 1.80 77.4 ± 1.60 > 0.05 Albumin,% 42.5 ± 1 = 0.86 45.1 ± 0.70 <0.05 Gammaglobulins,% 23.6 ± 1.34 19.5 ± 1.15 <0.05 Ac AT, mmol / l 1.63 ± 0.16 0.67 ± 0.20 <0.05 Al AT, mmol / l 1.78 ± 0.13 0.95 ± 0.15 0.05 Thymol test, units 44.0 ± 4.35 32.4 ± 3.05 0.05 Bilirubin, μmol / L 38.1 ± 2.41 26.6 ± 2.89 0.05 HCVRNA ++++ Duration of remission Clinical 6 months Biochemical 6 months Virological 6 months

table 2 Clinical and laboratory parameters obtained using the prototype method Indicators Before treatment After treatment R Hemoglobin, g / l 115.0 ± 10.0 110.0 ± 11.0 > 0.05 Red blood cells × 10 ¹² / L 4.55 ± 0.40 4.10 ± 0.35 > 0.05 White blood cells × 10 ⁹ / L 4.9 ± 0.50 4.00 ± 0.50 <0.05 Platelets × 10 ⁹ / L 200.0 ± 19.5 175.0 ± 15.8 > 0.05 ESR, mm / hour 16.0 ± 0.74 14.0 ± 0.65 <0.05 Alkaline phosphatase, E / l 62.0 ± 1.90 54.0 ± 1.30 <0.05 Total protein, g / l 72.5 = 1.50 71.0 ± 1.80 > 0.05 Albumin,% 44.5 ± 1 = 0.85 45.0 ± 0.78 <0.05 Gammaglobulins,% 23.5 ± 1.20 21.6 ± 1.15 <0.05 Ac AT, mmol / l 1.52 ± 0.15 1.45 ± 0.13 <0.05 Al AT, mmol / l 1.80 ± 0.12 1,50 ± 0,15 <0.05 Thymol test, units 35.0 ± 4.10 33.0 ± 3.80 > 0.05 Bilirubin, μmol / L 34.5 ± 2.00 25.0 ± 1.5 <0.05 HCV RNA ++++ + Duration of remission Clinical 6 months Biochemical No Virological No

Claims (1)

A method for the treatment of chronic viral hepatitis C genotype-2 with moderate activity by drug exposure, including parenteral administration of interferon α 2b at a dose of 3 ml ME 3 times a week and parenteral daily administration of solutions containing a mixture of amino acids, nucleotides and enzyme, 0 are administered on the first day , 2 ml of a 0.01% solution containing a mixture of amino acids: lysine, arginine, asparagine and glutamic acid in equal amounts, and the next day 0.2 ml of a 0.02% solution containing a mixture of hell nucleotides is administered nosin and inosine, the amino acids of guanosine, as well as the lysozyme enzyme in equal amounts, moreover, the solution is alternated daily throughout the course of treatment, after 9-11 days of administration of the solutions, the course of treatment is carried out against the background of parenteral administration of interferon α 2b, the course of treatment is 6 months, 9 days - 6 months, 11 days, and every 2 months they take a break in the introduction of amino acids in 28-32 days.