RU2571495C1 - Method of treating patients with intestinal disbacteriosis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: hepatotropic preparation Hepaguard Active is administered in a dose of 1 capsule 3 times a day at mealtimes for 28-30 days.

EFFECT: method enables recovering and maintaining the optimum health of intestinal microbiocenosis by ensuring a possibility to have an effect on its various links.

3 tbl, 4 ex

Description

The invention relates to the field of medicine, namely gastroenterology, and can be used in the treatment of patients with intestinal dysbiosis.

To date, the problem of adequate correction of disorders of the intestinal microbiocenosis and its maintenance at the optimal level is one of the most relevant [1, 2]. It is believed that the fundamental principle step in optimizing microecological disorders is the correction of dysbiotic disorders, while the therapeutic effect should be directed at both structural elements of the symbiotic system: the human body and intestinal microflora [3, 4, 5].

The positive effect of agents that correct microbiocenosis in the human body is mediated by inhibition of growth, reproduction and colonization of pathogenic and conditionally pathogenic microorganisms, the creation of optimal conditions for the development of endogenous obligate microorganisms, immunomodulation, a direct effect on the physiological functions and biochemical reactions of the body.

In order to inhibit the growth, reproduction and colonization of pathogenic and opportunistic microorganisms, antibacterial drugs are used, however, the possibility of suppressing symbiotic microbiota and an increase in the number of resistant forms thus limit their use [6, 7, 8]. Absolute indications are bacteremia and the threat of enterogenic sepsis due to dysbiosis. The drugs of choice in this case are broad-spectrum antibiotics, to which the microbes found in the blood are sensitive. Relative indications for antibiotic therapy may be chronic diarrheal diseases with excessive bacterial growth of pathogenic microbial flora in the lumen of the small intestine (post-resection syndrome of the small intestine, adhesions, general variable hypogammaglobulinemia, celiac disease with a torpid course) [9]. On the other hand, the indication for the appointment of antimicrobial agents is a persistent increase in the number of opportunistic microflora of more than 10 ⁴ -10 ⁵ in one gram, accompanied by severe intestinal and somatic disorders. At the same time, it is recommended to use intestinal antiseptics (intetrix, nifuroxazide, nitroxoline, furazolidone) with a less pronounced adverse effect on the symbiotic microbial flora than antibiotics [10]. Moreover, there is an opinion that for diseases accompanied by intestinal dysbiosis, antibacterial drugs are not indicated at all, and in patients with asymptomatic dysbiosis, no special treatment is required at all [11, 12]. It should also take into account the direct or ideosyncratic hepatotoxic effect of antibacterial drugs, which can worsen the clinical course of liver disease, and, in general, the state of homeostasis [13, 14, 15].

Probiotics are drugs that contain living microorganisms and substances of microbial and other origin that optimize the microecological status of the body and thereby have beneficial effects on its physiological functions, biochemical and behavioral reactions. However, given the fact that this definition of probiotics summarizes them with all means of treating dysbiosis, usually only drugs containing live cultures of microorganisms are classified as probiotics.

Criteria have been developed that are important for evaluating the probiotic used: harmlessness (GRAS criteria), antagonism to pathogens, vitamin formation, high resistance to various physicochemical factors (temperature, pH, osmotic shock), high vitality and manufacturability, belonging to the normal intestinal microflora.

With respect to safety, the GRAS criteria (Generally regarded as safe) imply long-term use of large doses of the bacterial strain, at least 100 times the therapeutic dosage, without any pathological consequences for the person or laboratory animal being tested. However, the real mechanisms that could potentially lead to the occurrence of diseases due to the intake of such a probiotic strain are not studied or investigated. There is only the practice of careful attitude to those bacteria whose genetically related strains can cause infectious processes.

However, while the safety of the majority of probiotic strains of lactobacilli, thermophilic streptococci and bifidobacteria is not in serious doubt, none of these bacterial species fully meets the above criteria [16].

The weak point of most strains of bifidobacteria and lactobacilli is insufficient vitality when exposed to extreme factors such as bile, temperature and high acidity, as well as low survival and antagonistic activity to pathogens. Thus, under the action of bile, bifidobacteria lose their ability to adhere and autoaggregate due to the violation of surface hydrophobic structures. An analysis of the spectrum of intestinal lactobacilli after a two-week course of L. acidophilus NCFM in a daily dose of 10 ¹⁰ showed that bacterial engraftment does not take place after a 2-week course. Similar data were obtained for bifidobacteria. The duration of persistence in the intestine after taking Bifidobacteria Bb-12 was 7 days [23, 24, 25, 26]. Thermophilic streptococci with all the same disadvantages do not apply to representatives of the normal intestinal microflora.

The clinical efficacy of traditional single drugs acting on both structural elements of the symbiotic system: the human body and intestinal microflora, ranges from 50-55% [17, 23].

Currently, drugs and food additives containing various microorganisms are used: bifidobacteria (Bifidobacterium bifidum, B.infantis, B.longum, B.breve, B. adolescentis, B. lactis, B.animals) - Bifiform, Bifidobacteria, lactobacillus (Lactobacillus GG, L.acidophilus, L.plantarum, L.casei spp.rhamnosus, L.brevis, L.helveticus, L.delbrueckii spp.bulgaricus, L.femientum, Llactis) - Laminolact, Lactobacterin, lactococcus (Lactococcus spp. Cremonis L .lactis spp. Lactis), E. coli (Escherichia coli), enterococci (Enterococcus faecium, E.faecalis), streptococci (Streptococcus salivarium spp. thermophilus, S.faecium, S. cremoris, S. lactis), propioni bacteria (Propionibacter) acnes), bacilli (Bacillus subtilis), saccharomycetes ( Saccharomyces boulardii). Probiotics can contain monoculture (Bifidumbacterin dry, Bifidumbacterin forte, Bifilis, Bifilin, Lactobacterin, Acylact, Kolibacterin dry), and several types of microorganisms - symbiotics (Linex, Bifikol, Bifilong, Bifatsid, Bifiton).

As probiotics, self-eliminating anagonists can be used - microorganisms that do not belong to obligate intestinal microflora, but have a pronounced antagonism to pathogenic and conditionally pathogenic microorganisms - Biosporin (Bacillus subtilis), Enterol (Saccharomyces boulardii).

Nevertheless, preparations based on living microorganisms cannot always ensure the restoration and maintenance of the optimal state of intestinal microbiocenosis due to inactivation during storage, low initial concentration of microorganisms in the drug, inactivation in the stomach, small intestine, the possibility of exposure only to individual links of microbiocenosis, and the inability of exogenously introduced microorganisms persist for a long time in the human intestine [17, 18, 19, 20, 21].

Based on the assumption that the effect of probiotics is largely due to the effect of their metabolic products and metabolites on the microbiocenosis of the body, trophism and the function of epithelial cells and colonocytes, Hilak forte preparations containing metabolic products of normal intestinal microflora (lactic acid, lactose, amino acids and fatty acid).

A group of prebiotics is also distinguished - industrially produced medicines and biologically active additives that do not contain live microorganisms that can have a beneficial effect on the human body through stimulation of the growth and (or) activity of the representatives of the symbiotic microflora of the body.

In modern literature, there is a narrower definition of prebiotics. These include only indigestible food ingredients capable of selectively stimulating the growth and / or metabolic activity of one or more groups of bacteria living in the colon [22]. In this case, the food component should not be hydrolyzed by digestive enzymes and absorbed in the upper digestive tract, it should be a selective substrate for the growth and / or metabolic activation of one species or a certain group of microorganisms that inhabit the intestine, leading to the normalization of their ratio. A greater number of compounds have a prebiotic (bifidogenic) effect: oligosaccharides (lactulose, fructooligosaccharides, galactooligosaccharides); monosaccharides (xylitol, raffinose); alimentary fiber; plant and microbial extracts (yeast, carrot, potato, corn, rice, pumpkin, garlic); enzymes (saccharomycete proteases - galactosidases of microbial origin); polysaccharides (pectins, dextrin, inulin); amino acids (valine, arginine, glutamic acid); antioxidants (vitamins A, C, E, carotenoids, selenium salts); unsaturated fatty acids (eicosopentaenoic acid); extracts of various algae - Eubikor, Probolans, Laminolact.

One of the directions in the treatment of intestinal dysbiosis is the use of synbiotics - drugs consisting of a combination of living microorganisms and prebiotics (Bifiform, Laminolact). The bifiform contains the probiotic complex B.longus, E.faecium, as well as milk yeast, soybean oil, lactulose, acetylated monoglycerides, glucose, magnesium stearate, and silica bean syrup.

Laminolact as a prebiotic component includes short peptides, pectins and a complex of microelements. The constituent ingredients of the product suggest reparative and protective activity in relation not only to the intestinal epithelium, but also to hepatocytes, which can probably lead to a decrease in the severity of the cytolytic syndrome.

Preparations based on living microorganisms cannot always ensure the restoration and maintenance of the optimal state of intestinal microbiocenosis due to inactivation during storage, low initial concentration of microorganisms in the preparation, inactivation in the stomach, small intestine, the possibility of exposure only to individual links of microbiocenosis, and the inability of exogenously introduced microorganisms to persist for a long time human intestines.

As a prototype for the closest technical essence, we have chosen a method of treating patients with intestinal dysbiosis, which consists in taking the drug Eubicor.

From the instructions for use of the drug:

- Supplements - carbohydrates and their processed products

- Supplements - vitamin and mineral complexes

- Supplements - probiotics and prebiotics

- Supplements - proteins, amino acids and their derivatives

- Composition and form of release

Powder 1 pack

inactivated yeast culture Saccharomyces

cerevisiae (vini)

alimentary fiber

vitamins, amino acids, macro- and microelements

in bags of 1.5 g; in a pack of cardboard 30 sachets or in bags of 3 g; in a pack of cardboard 30 or 60 bags.

Dosage and administration: Inside.

Single dose regimen

For 1.5 g sachets: children from 3 to 6 years old - 1 pack .; from 6 to 12 years - 2 pack.

For bags of 3.0 g: adults and children over 12 years old - 1-2 pack.

During the course of taking Eubicor ^® increase the usual daily amount of fluid consumed, except in cases of diarrhea.

Prevention of dysbiosis (to any healthy person): at an age-related dosage 2 times a day, morning and evening, washed down with water or with food (adding to non-hot foods) for at least 2 weeks.

For dysbacteriosis, as well as in combination with antibiotics and other drugs during and after any illness: in an age-specific dosage 2-3 times a day, morning and evening, drinking water or while eating (adding to non-hot food), at least 3 weeks.

In case of intoxication (infectious, food, alcoholic): take a double age dosage every 30-40 minutes until the condition improves, washed down with water. Then take the course recommended for dysbiosis (see above).

With diarrhea: in the acute period, take a double age dosage every 30-40 minutes until the condition improves. In this case, the amount of liquid washed down is minimal (only ensuring the swallowing of the powder). Then take the course recommended for dysbiosis (see above).

For constipation: at the appropriate age dosage 3 times a day, 0.5 hours before meals, drinking plenty of water. During the day, you must follow the drinking regime (drink 1.5-2 liters of fluid per day)! Course duration 3-4 weeks.

If there are errors in the diet (heartburn, belching, flatulence, discomfort in the stomach): age-related dosage every 2 hours until the condition improves, drinking well with water. Then take the course recommended for dysbiosis (see above).

With simultaneous use with other drugs, an interval of at least 30 minutes is recommended.

The advantage of Eubicor ^® is the possibility of taking it during antibiotic treatment.

The disadvantage of the method chosen by us as a prototype is the insufficiently high efficiency of treatment of patients with intestinal dysbiosis.

The technical result of the invention is to increase the efficiency of restoration and maintenance of the optimal state of intestinal microbiocenosis in the treatment of patients with intestinal dysbiosis.

The technical result of the invention is achieved by administering the preparation Hepagard Active in a dose of 1 capsule 3 times a day with meals for 28-30 days.

Hepagard Active®

produced by NPF BIOS LLC AnviLab LLC

Composition Capsules 0.36 g

1 caps.

essential 222 mg L-carnitine phospholipids 133 mg vitamin tartrate Ε 1.25 mg

(tocopherol acetate)

Release form and packaging - Capsules weighing 0.36 g. No. 30

10 pieces. - blisters (1) - packs of cardboard 3 blisters in a pack.

Approved for use in Russia.

Certificate of State Registration

No. RU. 77.99.11.003.E.012482.08.12 of 08.13.2012.

Recommended as a biologically active food supplement - an additional source of vitamin E, a source of L-carnitine containing phospholipids.

Properties:

Hepagard Active® dietary supplement helps to normalize lipid metabolism, lower cholesterol, improve the functional state and metabolic function of the liver, protect it from obesity and activate the antioxidant system of the body, increase the body's resistance to toxic substances, maintain the function of the nervous system and protect cell membranes.

Essential phospholipids (EFL) - (“essential” means irreplaceable) - substances of natural origin, necessary for the normal functioning of the liver, help liver cells recover by integrating into the damaged hepatocyte membrane. EFL protect liver cells from free radicals, i.e. actively resist oxidative stress, which allows cells to cope with inflammation faster and better detoxify. Soya bean lecithin contains up to 97% EFL and polyunsaturated fatty acids. EFLs are an excellent “solvent” for cholesterol: one phospholipid molecule can bind three cholesterol molecules and excrete them from the body, and phospholipids are able to extract cholesterol both from atherosclerotic plaques and from cell membranes, in case of cholesterolosis. In doses of 300 mg / day, ETFs also exhibit a neurotropic effect, affecting the synthesis of acetylcholine in the brain.

L-carnitine stimulates the utilization of fatty acids, helps liver cells get rid of accumulated fat. L-carnitine is a key factor in the transfer of fatty acids to mitochondria, where fats alone cannot penetrate. If fatty acids remain in the blood without entering the mitochondria, they will accumulate in the cytoplasm of the cells (fill the cell with fat) and activate the processes of lipid peroxidation and degradation of cell membranes, which ultimately leads to cell death. Without L-carnitine, the body loses its ability to activate (“burn”) fats.

Vitamin Ε supports the integrity and stability of the membranes of liver cells, protects their outer layer of destruction, generally slows down the aging process of the body and maintains hormonal balance. Vitamin Ε is a protective membrane, it inactivates free radicals, protects the phospholipid layer of cells from peroxidation, restricting the access of oxygen and prevents its destruction. Tocopherol in the human body is not synthesized and refers to the necessary nutrition factors - vitamins. In the human body, vitamin Ε is concentrated in the tissues of the pituitary gland, liver, kidneys, and adrenal glands. A decrease in the content of vitamin Ε in blood plasma directly correlates with the degree of damage to the functions of the liver and gastrointestinal tract.

The composition of the active substances contained in the Hepagard Active® product effectively combines the pharmacodynamic membrane-protective effects of phospholipids with vitamin Ε and the lipotropic effect of L-carnitine.

Contraindications - Individual intolerance to the components. Before use, it is recommended to consult a doctor. Directions for use - Adults take 1 capsule 3 times a day with meals. Duration of admission is 1 month.

Not a cure.

The method is as follows.

The drug Hepagard Active is taken 1 capsule 3 times a day with meals for 28-30 days.

Distinctive essential features of the proposed method and a causal relationship between them and the achieved technical result.

Hepagard Active is taken with intestinal dysbiosis, 1 capsule 3 times a day with meals, the duration of administration is 28-30 days.

For the first time, we have established the positive effect of the combined hepatotropic drug Hepagard Active on the normalization of intestinal microflora.

Initially, the Hepagard Active drug, which is a hepatoprotector, was prescribed by us to patients with non-alcoholic fatty liver disease (NAFLD) and intestinal dysbiosis.

In patients with NAFLD, after taking Hepagard Active, there was an improvement in liver function due to an improvement in protein-synthetic function, a decrease in asthenovegetative syndrome, and normalization of the lipid profile. At the same time, we found that in these patients normalization of intestinal microflora was also observed according to the results of bacteriological studies and in the quantitative determination of representatives of the main bacterial groups in the feces by PCR. We hypothesized that the hepatoprotector Hepagard Active can have not only a normalizing effect on liver function, but also on intestinal microflora. In this connection, we decided to study the effect of the hepatoprotector Hepagard Active on intestinal microbiocenosis.

The results of our studies confirmed the assumption that the hepatoprotector Hepagard Active has a prebiotic property. In all 10 patients, intestinal dysbiosis was confirmed, but there was no data for the presence of chronic liver pathology. In this group of patients, against the background of Hepagard Active therapy, we noted the normalization of intestinal microflora.

We first established the positive effect of the drug Hepagard Active on the course of intestinal dysbiosis. In the Instructions section “Indications for the use of the Hepagard Active drug, there is no information on the use of the drug for the treatment of patients with intestinal dysbiosis. The Hepagard Active drug affects various parts of microbiocenosis. EFL, vitamin Ε and L-carnitine, stabilize the hepatocyte membrane, normalize production and current bile, which is an antiseptic for the intestine, which has beneficial effects on intestinal microbiocinosis. The selected dosage, frequency and duration of administration of Hepagard Active provide maximum effectiveness. nost in the treatment of patients with intestinal dysbiosis.

The set of distinctive essential features of the proposed method is new, increases the efficiency of restoration and maintenance of the optimal state of intestinal microbiocenosis in the treatment of patients with intestinal dysbiosis, compared with the prototype.

Perhaps in this way a prebiotic effect is created that contributes to the normalization of intestinal microbiocenosis.

We give examples from clinical practice.

Example 1

Patient Z., 43 years old.

Complaints: On the feeling of fullness in the abdomen due to increased gas formation; nausea with a saved appetite; flatulence, unstable stools: alternating diarrhea and constipation.

From the anamnesis it is known that the above complaints in patient Z. appeared after taking antibiotics (Flemoxin salutab 500 mg 2 times a day for 10 days) regarding outpatient treatment of bronchitis.

Objectively: On palpation: rumbling, increased tone in the cecum and sigmoid colon.

Conclusion: Based on complaints, examination and clinical and laboratory data, patient Z. has intestinal dysbiosis of the 2nd degree.

Clinical and laboratory tests during the treatment of patient Z .:

Hemoglobin level - 125 g / l, erythrocytes - 4.5 × 10 ¹² / l, white blood cells - 6.3 × 10 ⁹ / l, ESR - 12 mm / h, platelets - 208 × 10 ⁹ / l, Al AT - 24 units / l, AsAT - 29 units / l, alkaline phosphatase - 169 units / l, total bilirubin - 15 units / l, cholesterol 6.1 mmol / l The level of lactobacilli - 10 ⁵ , bifidobacteria - 10 ⁵ , intestinal bacilli with normal enzymatic activity - 10 ⁶ , E. coli with reduced enzymatic activity - 10 ³ , enterococcus - 10 ³ , yeast-like fungi of the genus Candida - 10 ⁵ . Thus, the examined 3., according to the results of bacteriological studies, there are changes characteristic of dysbacteriosis of the colon of the 2nd degree.

Treatment:

For 28 days, the patient received therapy with the drug Hepagard Active 1 capsule 3 times a day.

Clinical and laboratory analyzes of patient Z. after treatment:

Hemoglobin level - 126 g / l, erythrocytes - 4.7 × 10 ¹² / l, white blood cells - 5.8 × 10 ⁹ / l, ESR - 8 mm / h, platelets - 208 × 10 ⁹ / l, AlAT - 25 units ./l, AsAT - 34 units / L, alkaline phosphatase - 166 units / L, total bilirubin - 14 units / L, cholesterol 5.4 mmol / L The level of lactobacilli - 10 ⁸ , bifidobacteria - 10 ⁶ , E. coli with normal enzymatic activity - 10 ⁷ , E. coli with reduced enzymatic activity - 10 ² , enterococcus - 10 ⁶ , yeast-like fungi of the genus Candida - 10 ³ .

The condition remained stable 3 months after discontinuation of the drug.

So, the level of lactobacilli is 10 ⁸ , bifidobacteria - 10 ⁶ , E. coli with normal enzymatic activity - 10 ⁶ , E. coli with reduced enzymatic activity - 10 ² , enterococcus - 10 ⁶ , yeast-like fungi of the genus Candida - 10 ² .

Example 2

Patient S., 48 years old.

Complaints: On a feeling of heaviness and pain in the abdomen, like intestinal colic, a feeling of fullness in the abdomen, increased gas formation, aerophagia, belching, nausea while maintaining appetite; a change in the nature of feces - unformed mushy.

From the anamnesis it is known that the above complaints in patient C. appeared after taking antibiotics (amoxicillin 500 mg 2 times a day for 10 days, erythromycin 500 mg 2 times a day, 10 days) regarding the treatment of Hp-associated gastritis.

Objectively: On palpation: rumbling, increased tone in the transverse colon and sigmoid colon.

Conclusion: On the basis of complaints, examination and clinical and laboratory data, patient S. has intestinal dysbiosis of the 2nd degree.

Clinical and laboratory tests during the treatment of patient C.

Hemoglobin level - 124 g / l, erythrocytes - 4.7 × 10 ¹² / l, white blood cells - 6.1 × 10 ⁹ / l, ESR - 11 mm / h, platelets - 220 × 10 ⁹ / l, AlAT - 30 units ./l, AsAT - 29 units / l, alkaline phosphatase - 181 units / l, total bilirubin - 15 units / l, cholesterol 6.8 mmol / l The level of lactobacilli - 10 ⁵ , bifidobacteria - 10 ⁴ , E. coli with normal enzymatic activity - 10 ⁶ , E. coli with reduced enzymatic activity - 0, enterococcus - 10 ³ , yeast-like fungi of the genus Candida - 10 ⁵ . Thus, subject S., according to the results of bacteriological research, has changes characteristic of dysbacteriosis of the colon of the 2nd degree.

Treatment:

For 30 days, the patient received therapy with Hepagard Active 1 capsule 3 times a day.

Clinical and laboratory analyzes of patient C. after treatment

Hemoglobin level - 126 g / l, erythrocytes - 4.9 × 10 ¹² / l, white blood cells - 6.2 × 10 ⁹ / l, ESR - 8 mm / h, platelets - 214 × 10 ⁹ / l, AlAT - 24 units ./l, AsAT - 24 units / L, alkaline phosphatase - 158 units / L, total bilirubin - 14 units / L, cholesterol 5.2 mmol / L The level of lactobacilli - 10 ⁸ , bifidobacteria - 10 ⁶ , E. coli with normal enzymatic activity - 10 ⁷ , E. coli with reduced enzymatic activity - 10 ² , enterococcus - 10 ⁶ , yeast-like fungi of the genus Candida - 10 ³ .

The condition remained stable 3 months after discontinuation of the drug.

So, the level of lactobacilli is 10 ⁸ , bifidobacteria - 10 ⁶ , E. coli with normal enzymatic activity - 10 ⁷ , E. coli with reduced enzymatic activity - 10 ³ , enterococcus - 10 ⁶ , yeast-like fungi of the genus Candida - 10 ² .

Example 3 (prototype method)

Patient I., 45 years old.

Complaints: On a feeling of fullness in the stomach, belching; monotonous abdominal pains, a feeling of fullness in the abdomen, increased gas formation, rumbling, nausea with a saved appetite; flatulence, a change in the nature of feces - a tendency to constipation.

From the anamnesis it is known that the above complaints in patient Ya appeared after taking antibiotics (penicillin 1000 mg 2 times a day for 10 days, amoxicillin 500 mg 2 times a day for 10 days) regarding the treatment of focal community-acquired pneumonia in a hospital.

Objectively: On palpation: rumbling, increased tone in the sigmoid colon.

Conclusion: Based on complaints, examination, and clinical and laboratory data, patient Y. has intestinal dysbiosis of the 2nd degree.

Clinical and laboratory tests during the treatment of patient I.

Hemoglobin level - 122 g / l, erythrocytes - 4.2 × 10 ¹² / l, white blood cells - 6.3 × 10 ⁹ / l, ESR - 10 mm / h, platelets - 216 × 10 ⁹ / l, AlAT - 18 units ./l, AsAT - 26 units / l, alkaline phosphatase - 150 units / l, total bilirubin - 14 units / l, cholesterol 6.6 mmol / l. The level of lactobacilli - 10 ⁵ , bifidobacteria - 10 ⁵ , E. coli with normal enzymatic activity - 10 ⁶ , E. coli with reduced enzymatic activity - 0, enterococcus - 10 ³ , yeast-like fungi of the genus Candida - 10 ⁵ . Thus, the subject I., according to the results of bacteriological research, has changes characteristic of intestinal dysbiosis of the 2nd degree.

Treatment:

For 30 days, the patient received therapy with Eubicor in a standard dosage - 1 sachet (3.0 g) 3 times a day.

Clinical and laboratory analyzes of patient I. after treatment

Hemoglobin level - 122 g / l, erythrocytes - 3.9 × 10 ¹² / l, white blood cells - 5.0 × 10 ⁹ / l, ESR - 12 mm / h, platelets - 215 × 10 ⁹ / l, AlAT - 16 units ./l, AsAT - 28 units / l, alkaline phosphatase - 148 units / l, total bilirubin - 17 units / l, cholesterol 6.8 mmol / l The level of lactobacilli - 10 ⁸ , bifidobacteria - 10 ⁶ , E. coli with normal enzymatic activity - 10 ⁷ , E. coli with reduced enzymatic activity - 10 ² , enterococcus - 10 ⁶ , yeast-like fungi of the genus Candida - 10 ⁴ .

3 months after discontinuation of the drug, the patient noted a deterioration in the condition to the initial level.

According to the bacteriological study on dysbiosis, the level of lactobacilli is 10 ⁶ , bifidobacteria - 10 ⁵ , E. coli with normal enzymatic activity - 10 ⁵ , E. coli with reduced enzymatic activity - 10 ² , enterococcus - 10 ⁶ , yeast-like fungi of the genus Candida - 10 ⁵ .

Example 4 (comparison drug - hepatotropic drug Essential)

Patient Α., 48 years old.

Complaints: On colicky abdominal pain that disappears after bowel movement; a feeling of fullness, increased gas formation, nausea with a saved appetite; flatulence, a change in the nature of the stool - an alternation of diarrhea and constipation.

From the anamnesis it is known that the above complaints in patient A. appeared after taking antibiotics (amoxicillin 500 mg 2 times a day for 7 days) regarding the treatment of acute respiratory viral infections on an outpatient basis.

Objectively: On palpation: rumbling, increased tone in the transverse colon and sigmoid colon.

Conclusion: Based on complaints, examination and clinical and laboratory data, patient A. has intestinal dysbiosis of the 2nd degree.

Clinical and laboratory tests during the treatment of patient A.

Hemoglobin level - 128 g / l, red blood cells - 4.8 × 10 ¹² / l, white blood cells - 6.0 × 10 ⁹ / l, ESR - 11 mm / h, platelets - 212 × 10 ⁹ / l, AlAT - 22 units ./l, AsAT - 15 units / l, alkaline phosphatase - 82 units / l, total bilirubin - 15 units / l, cholesterol 6.2 mmol / l The level of lactobacilli - 10 ⁵ , bifidobacteria - 10 ⁴ , E. coli with normal enzymatic activity - 10 ⁶ , E. coli with reduced enzymatic activity - 0, enterococcus - 10 ³ , yeast-like fungi of the genus Candida - 10 ⁵ . Thus, subject Α., According to the results of bacteriological research, has changes characteristic of intestinal dysbiosis of the 2nd degree.

Treatment:

For 30 days, the patient received therapy with Essentiale 2 capsules 3 times a day.

Clinical and laboratory analyzes of patient A. after treatment

Hemoglobin level - 122 g / l, erythrocytes - 3.9 × 10 ¹² / l, leukocytes - 5.0 × 10 ⁹ / l, ESR - 12 mm / h, platelets - 212 × 10 ⁹ / l, AlAT - 17 units ./l, AsAT - 18 units / l, alkaline phosphatase - 84 units / l, total bilirubin - 16 units / l, cholesterol 6.4 mmol / l The level of lactobacilli - 10 ⁸ , bifidobacteria - 10 ⁶ , E. coli with normal enzymatic activity - 10 ⁷ , E. coli with reduced enzymatic activity - 10 ² , enterococcus - 10 ⁶ , yeast-like fungi of the genus Candida - 10 ³ .

3 months after discontinuation of the drug, the patient noted a deterioration to the initial level, from the side of the stool - a tendency to constipation. So, the level of lactobacilli is 10 ⁶ , bifidobacteria - 10 ⁵ , E. coli with normal enzymatic activity - 10 ⁵ , E. coli with reduced enzymatic activity - 10 ² , enterococcus - 10 ⁶ , yeast-like fungi of the genus Candida - 10 ⁴ .

The above clinical examples indicate a higher efficiency of the proposed method for the treatment of patients with intestinal dysbiosis, compared with the prototype method (using Eubicor for the treatment of patients with intestinal dysbiosis).

The inventive method of treating patients with intestinal dysbiosis was tested in 25 patients with manifestations of intestinal microbiocenosis in the North-Western State Medical University named after I.I. Mechnikov, of which 10 patients - according to the claimed method (1st group), 10 patients - according to the prototype method (2nd group) and 5 patients - using the hepatotropic drug Essentiale (3rd group). Testing results are presented in the tables below.

The above data in the tables indicate a higher efficiency of restoring the optimal state of intestinal microbiocenosis in patients with intestinal dysbiosis using the proposed method (group 1), compared with the prototype (group 2).

When using the Essentiale hepatoprotector (group 3), the restoration of the optimal state of intestinal microbiocenosis in patients with intestinal dysbiosis was not observed, which indicates the absence of prebiotic properties in the Essentiale hepatoprotector that contribute to the normalization of intestinal microbiocenosis.

In patients of the first group, the condition remained stable 3 months after discontinuation of the drug. In the second group, 3 months after discontinuation of the drug, patients noted a deterioration in their condition to the initial level. In the third group, there was no improvement in the restoration of the optimal state of intestinal microbiocenosis.

Thus, Hepagard Active can be recommended for the treatment of patients with intestinal dysbiosis due to the fact that Hepagard Active has prebiotic properties inherent in drugs that normalize intestinal microbiocenosis.

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Claims (1)

A method of treating patients with intestinal dysbacteriosis, consisting in a drug effect, characterized in that they take the hepatotropic drug Hepagard Active 1 capsule 3 times a day with meals for 28-30 days.