RU2519198C2 - Method of treating patients suffering from first stage cholelithiasis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely gastroenterology, and may be used for treating the patients with the first stage cholelithiasis. That is ensured by administering the preparation Mucofalc 1 sachet 3 times a day for 22-24 weeks.

EFFECT: method enables extending the range of drug preparations having litholytic action in the first stage cholelithiasis with no side effects.

2 tbl, 2 ex

Description

The invention relates to medicine, namely gastroenterology, and can be used in the treatment of patients with cholelithiasis of the first stage (biliary sludge).

At present, cholelithiasis (cholelithiasis) is widespread. It takes second place in frequency after peptic ulcer of the stomach and duodenum. Treatment of cholelithiasis is an urgent problem, since there is a tendency to growth and rejuvenation of this disease. In economically developed countries, ZhKB develops in 10-15% of the population. The annual circulation in Russia is about 1 million people per year. The prevalence of biliary sludge in the general population is 1.7–4%, and among people with gastroenterological complaints - 7.5% [1, 2, 3, 4, 5, 6, 7]. Since there is a steady tendency to the prevalence of cholelithiasis, the number of surgical interventions for cholelithiasis is also increasing, and the widespread introduction of less invasive laparoscopic cholecystectomy in surgery helps to expand the indications for this operation [5, 6].

Gallstone disease is a disease characterized by the formation of calculi in the gallbladder (cholecystolithiasis), the common bile duct (choledocholithiasis), which can occur with symptoms of bile (biliary, hepatic) colic in response to transient obstruction with a stone of the cystic or common bile duct, accompanied by spasm of smooth muscles and intraductal hypertension [2, 8].

According to the classification of cholelithiasis, adopted in 2002 by the Congress of the Scientific Society of Gastroenterologists of Russia, there are four stages of the disease:

Stage 1 - initial or prediscal: dense, heterogeneous bile in the absence of calculi; the formation of biliary sludge.

Stage 2 - the formation of gallstones.

Stage 3 - stage of chronic recurrent calculous cholecystitis.

Stage 4 - complications.

Localization is divided into: stones in the gallbladder, stones in the common bile duct, stones in the hepatic ducts.

By the number of stones: single, multiple.

The composition is mainly distinguished: cholesterol stones, pigmented, calcined, mixed.

According to the clinical course: latent form, with the presence of clinical symptoms - pain form with typical biliary colic, dyspeptic form, under the guise of other diseases [7, 8].

The identification of cholelithiasis at its initial stage, the formation of biliary sludge, presents great opportunities for the primary prevention of cholelithiasis [1, 7]. Since the detection of the disease at the 2nd, 3rd and 4th stages of the clinical course of cholelithiasis, when the stones have already formed and cause some discomfort and threaten the development of complications, the main treatment method is surgical. Traditionally, it is believed that the presence of stone in the gallbladder serves as an indication for surgery [3, 6, 7].

According to Gorshkov S.M., Kudrin I.T., 1967, the gallbladder performs a number of important functions, such as: reservoir; contractile (promotion of bile in the GWP); concentration (the gallbladder concentrates bile up to 10-fold, i.e. from 500 ml of hepatic bile 50 ml of cystic is formed); absorption (amino acids, albumin, inorganic substances); secretory (mucus, enzymes, electrolytes, etc.); hormonal (secretion by the walls of the gallbladder of a cholecystokinin antagonist - anticholecystokinin); enzymatic (acceleration of pancreatic lipase); regulatory (maintaining a sufficient level of bile components during digestion).

Contraindications to the use of conservative therapy of cholelithiasis: complicated cholelithiasis, acute and chronic cholecystitis; disabled IP; frequent episodes of biliary colic; pregnancy; obesity; open stomach ulcer and duodenum; concomitant liver disease; chronic diarrhea; carcinoma of the stomach; the presence in pigmented pigmented and calcified cholesterol stones; stones with a diameter of more than 15 mm; multiple stones [2].

Known methods of treating patients with cholelithiasis, consisting in drug therapy and dietary recommendations. The diet for cholelithiasis should be low-calorie, full and balanced, 5-6 meals a day are prescribed (diet within the limits of table No. 5). With bouts of biliary colic, hunger is needed for 2-3 days.

Management tactics depend on the form of biliary sludge and the state of contractile function of the gallbladder. The main goals of biliary sludge therapy are:

- improving the rheological properties of bile and dissolving biliary sludge, for this purpose apply ursodeoxycholic acid (UDCA), at a dose of 10 mg / kg body weight, once, for 1-2 months; cheno-deoxycholic acid, replacing 1/3 dose of UDCA;

- elimination of impaired functions of the gallbladder and sphincter of Oddi, myotropic antispasmodics (duspatalin) or prokinetics (trimedate), depending on the degree of dyskinetic disorders of the gallbladder and sphincter of Oddi; plant hepatoprotectors (hepatene) [1, 2, 5, 6, 7].

Symptomatic therapy of cholelithiasis in the 1st stage involves the restoration of normal lithogenicity of bile, dissolution of sludge and restoration of contractile function of the gallbladder.

As a prototype for the closest technical essence, we have chosen a method for the treatment of patients with stage 1 cholelithiasis, which consists in drug exposure, including the drug ursodeoxycholic acid - Ursosan, which is a hepatoprotector and has a litholytic effect. This method is the "gold" standard for the treatment of patients with cholelithiasis.

Ursosan.

Latin name - Ursosan ^®

Active ingredient - Ursodeoxycholic acid (Ursodeoxycholic acid)

ATX - A05AA02 Ursodeoxycholic acid

Pharmacological groups: Means that prevent the formation and promote the dissolution of calculi, hepatoprotectors, choleretic drugs and bile preparations

Nosological classification (ICD-10)

B18 Chronic viral hepatitis

E84.1 Cystic fibrosis with intestinal manifestations

K21.0 Gastroesophageal reflux with esophagitis

K70 Alcoholic liver disease

K71 Toxic liver damage

K73 Chronic hepatitis, not elsewhere classified

K74.3 Primary biliary cirrhosis

K76.0 Fatty degeneration of the liver, not elsewhere classified

K80 Gallstone disease [cholelithiasis]

K81 cholecystitis

K82.8.0 * Dyskinesia of the gallbladder and biliary tract

K83.0 Cholangitis

K83.1 Blockage of the bile duct

Composition and form of release - capsules, 1 capsule 250 mg of ursodeoxycholic acid.

Excipients: corn starch; pregelatinized corn starch; silicon dioxide colloidal; magnesium stearate; titanium dioxide; gelatin.

Pharmacological action - hepatoprotective, choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic, immunomodulatory.

Pharmacodynamics: having high polar properties, UDCA integrates into the membrane of the hepatocyte, cholangiocyte and gastrointestinal epithelial cell, stabilizes its structure and protects the cell from the damaging effects of toxic bile salts, thus reducing their cytotoxic effect. It forms non-toxic mixed micelles with apolar (toxic) bile acids, which reduces the ability of gastric reflux to damage cell membranes with biliary reflux gastritis and reflux esophagitis. By reducing concentration and stimulating bicarbonate-rich choleresis, UDCA effectively helps resolve intrahepatic cholestasis. In case of cholestasis, it activates Ca ²⁺ -dependent alpha-protease and stimulates exocytosis, reduces the concentration of toxic bile acids (chenodeoxycholic, lithocholic, deoxycholic, etc.), the concentrations of which are increased in patients with chronic liver diseases.

Competitively reduces the absorption of lipophilic bile acids in the intestine, increases their fractional circulation during enterohepatic circulation, induces choleresis, stimulates the passage of bile and the removal of toxic bile acids through the intestine. Reduces the saturation of bile with cholesterol due to inhibition of its absorption in the intestine, suppression of synthesis in the liver and lower secretion in bile; increases the solubility of cholesterol in bile, forming liquid crystals with it; reduces the lithogenic index of bile, increases the concentration of bile acids in it, causes an increase in gastric and pancreatic secretion, enhances lipase activity, and has a hypoglycemic effect. Reducing the saturation of bile with cholesterol promotes its mobilization from gallstones, which results in the dissolution (partial or complete) of cholesterol gallstones and the prevention of the formation of new calculi.

The immunomodulatory effect is due to inhibition of the expression of histocompatibility antigens (HLA-1 on the membranes of hepatocytes and HLA-2 on cholangiocytes), normalization of the natural killer activity of lymphocytes, the formation of IL-2, a decrease in the number of eosinophils, suppression of immunocompetent IgM, primarily Delays the progression of fibrosis. Regulates the apoptosis of hepatocytes, cholangiocytes and gastrointestinal epithelial cells.

Indications for the appointment of the drug Ursosan: uncomplicated gallstone disease: biliary sludge; dissolution of cholesterol gallstones with a functioning gallbladder; prevention of recurrence of stone formation after cholecystectomy; chronic hepatitis of various origins (toxic, medicinal, etc.); cholestatic diseases of the liver of various origins, including primary biliary cirrhosis, primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis); non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis; alcoholic liver disease; chronic viral hepatitis; biliary dyskinesia; biliary reflux gastritis and reflux esophagitis.

Contraindications: hypersensitivity; X-ray positive (high in calcium) gallstones; non-functioning gall bladder; severe impaired renal, liver, pancreas; decompensated liver cirrhosis; acute infectious and inflammatory diseases of the biliary tract.

UDCA has no age restrictions for use, however, in children under the age of 3 years, it is not recommended to use the drug in this dosage form.

Side effects of the drug Ursosan: diarrhea (may be dose-dependent). Rarely - calcification of gallstones, transient (transient) increase in the activity of hepatic transaminases, nausea, vomiting, abdominal pain, allergic reactions.

Dosage and administration: Inside, washed down with a small amount of water.

For the dissolution of cholesterol gallstones, the average daily dose of the drug is 10-15 mg / kg. The course of treatment is 6-12 months. and more until the stones are completely dissolved. In gallstone disease, the entire daily dose of the drug is taken once at night.

To prevent re-formation of stones, it is recommended to use the drug for several months after the dissolution of the stones.

After cholecystectomy for the prevention of re-cholelithiasis - 250 mg 2 times a day for several months.

With chronic hepatitis of various origins (toxic, medicinal, etc.), chronic viral hepatitis, non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis, alcoholic liver disease, the average daily dose is 10-15 mg / kg in 2-3 doses. The duration of therapy is 6-12 months. and more.

With cholestatic diseases of the liver of various origins, including primary biliary cirrhosis, primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis), the average daily dose is 12-15 mg / kg; if necessary, the average daily dose can be increased to 20-30 mg / kg in 2-3 doses. The duration of therapy is from 6 months. up to several years.

With biliary dyskinesia according to the hypokinetic type, the average daily dose is 10 mg / kg in 2 divided doses for 2 weeks to 2 months. If necessary, the treatment is recommended to be repeated.

With biliary reflux gastritis and reflux esophagitis - 250 mg / day before bedtime. The course of treatment is from 10-14 days to 6 months, if necessary - up to 2 years.

The disadvantage of the prototype method include possible side effects of the drug Ursosan, such as diarrhea, calcification of gallstones, transient (transient) increased activity of hepatic transaminases, nausea, vomiting, abdominal pain.

The technical result of the invention is the expansion of the arsenal of drugs that have a litholytic effect in stage 1 cholelithiasis, as well as the elimination of side effects exerted by the prototype, such as diarrhea, nausea, vomiting, abdominal pain, calcification of gallstones, increased activity of liver transaminases.

The technical result of the invention is achieved by the fact that the patient with cholelithiasis of the 1st stage is administered the drug Mukofalk 1 sachet 3 times a day, the duration of administration is 22-24 weeks.

Mukofalk.

Latin name Mucofalk ^®

ATX A06AS01 Isfagula (plantain oval or flea seeds)

Pharmacological group: laxatives in combinations

Nosological classification (ICD-10)

I84 Hemorrhoids

K50 Crohn's disease [regional enteritis]

K57 Diverticular bowel disease

K58 Irritable bowel syndrome

K59.0.0 * Constipation hypo - and atonic

K59.1 Functional diarrhea

K60 Crack and fistula in the anus and rectum

O26.8 Other specified conditions related to pregnancy

Z100 * CLASS XXII Surgical Practice

Composition and form of release: granules for preparation of suspension for oral administration with the aroma of orange, 1 sachet contains 3.25 g of plantago seed coat Plantago ovata.

Excipients: sucrose; dextrin; citric acid; sodium alginate; sodium citrate; sodium chloride; sodium saccharinate; orange flavor.

In bags of 5 g of granules; in a box of 20 bags.

Description of the dosage form. Light brown granules with inclusions from brown particles of the peel and adjacent cells of the membrane of the dried seeds of Plantago plantago ovata. The smell is orange.

Characteristic: laxative of plant origin.

Pharmacological action - laxative.

Pharmacodynamics Hydrophilic fibers from the shell of the seeds of plantain retain fluid in the digestive tract, due to this, the volume increases and the texture of the stool softens. The drug regulates the activity of the intestine, facilitating the passage of intestinal contents.

Indications for the appointment of the drug Mukofalk: constipation (including during pregnancy); anal fissures; hemorrhoids; postoperative period with interventions in the anorectal region (in order to create a softer consistency of the stool); functional diarrhea; irritable bowel syndrome; diverticulosis of the colon; Crohn's disease (stool normalization).

Contraindications: hypersensitivity to the drug; organic strictures of the digestive tract; intestinal obstruction; decompensated diabetes mellitus; children's age (up to 12 years).

Side effects of the drug Mukofalk: allergic reactions; may increase flatulence and the appearance of a feeling of fullness in the abdomen in the first days of admission.

Dosage and administration. Inside. Adults and children over 12 years old - 1 pack. 2-6 times a day.

Before use, the contents of 1 pack. pour into a glass in which cold water (150 ml) is slowly poured, stir and drink immediately. Then wash down with another glass of liquid.

Special instructions. It should not be prescribed simultaneously with antidiarrheal drugs, as well as with drugs that inhibit intestinal motility.

An interval of 30-60 minutes between taking Mukofalk and other drugs should be observed.

When taking the drug should drink at least 1.5 liters of fluid per day.

In patients with insulin-dependent diabetes, a reduction in insulin dose may be required.

It should be borne in mind that 5 g of granules contains the amount of digestible carbohydrates corresponding to 0.064 XE.

Storage conditions of the drug Mukofalk. In a dry place, at a temperature not exceeding 25 ° C.

The shelf life of the drug Mukofalk is 3 years.

The method is as follows.

The drug Mukofalk is taken 1 sachet 3 times a day, before eating, having previously dissolved in 1 glass of liquid, the duration of administration is 22-24 weeks. According to the indications, myotropic antispasmodics or prokinetics are prescribed.

Distinctive essential features of the proposed method and a causal relationship between them and the achieved effect

The patient is injected with Mukofalk, 1 sachet 3 times a day, the duration of administration is 22-24 weeks.

We found that when patients with cholelithiasis of the 1st stage of the drug Mukofalk are taken, resolution of biliary sludge is observed according to ultrasound data, as well as a decrease in astheno-vegetative, pain in the abdominal cavity, normalization of stool, improvement of liver function - normalization of cytolysis and cholestasis syndromes, protein -synthetic function, lowering cholesterol.

When Mukofalk is diluted with water, a gel-like mass is formed, consisting of a highly branched arabinoxylan, consisting of a skeleton formed by xylose, with arabinose and xylose-containing side chains. These compounds bind water, pathogenic bile acids, cholesterol and are excreted in the feces. To maintain the pool of FA and cholesterol, after adsorption, their synthesis is intensified from cholesterol in bile, which leads to a decrease in its amount in the bile. Free FAs bind more than conjugates, which leads to a decrease in the lithogenicity index of bile and a change in the qualitative composition of FAs. Perhaps, in this way, a litholytic effect is created that contributes to the resolution of biliary sludge in stage 1 gastrointestinal disease.

To date, of the entire set of preparations based on dietary fiber, not one drug has a litholytic property.

For the first time, we have established the positive effect of the drug Mukofalk on the resolution of biliary sludge in patients with stage 1 gastrointestinal disease. In the Instructions section "Indications for the use of the drug" MUKOFALK "" [9] there is no information on the use of the drug for the treatment of patients with cholelithiasis at the 1st stage of biliary sludge.

The selected dosage, multiplicity and duration of administration of the drug Mukofalk provide maximum effectiveness in the treatment of patients with cholelithiasis stage 1.

Distinctive essential features allow you to expand the arsenal of drugs that have a litholytic effect in stage 1 cholelithiasis, to eliminate the side effects of the prototype, such as diarrhea, nausea, vomiting, abdominal pain, calcification of gallstones, increased activity of liver transaminases.

We give examples from clinical practice:

Example 1. (Mukofalk)

And / b No. 1013, patient L., 39 years old, February 27, 2011

Complaints: general weakness, pulling pains in the right hypochondrium, nausea.

From the anamnesis it is known that he considers himself ill for about 3 months, when the above complaints first appeared. He does not follow a diet, food is irregular, 2-3 times a day, tendency to constipation, stool 1 time in 2-3 days. Heredity is burdened, in the mother of ZhKB. From the past diseases: chronic gastritis from the age of 19, cesarean section 3 years ago.

Objectively: the condition is satisfactory, the consciousness is clear. The skin and visible mucous membranes of normal color, clean. Pulse 84 beats per minute, rhythmic, satisfactory filling and tension. Blood pressure - 140/90 mm Hg With auscultation of the heart - tones are muffled. When examining mild pathological changes were not detected. The abdomen is of the correct form, increased in volume due to subcutaneous fat, body mass index (BMI) - 27.6, palpation is soft, painful in the right hypochondrium and in the epigastric region, a positive symptom of Kera. Liver on the edge of the costal arch. Ascites is not detected. Rumbling is painless. No peripheral edema.

Clinical and laboratory tests during the treatment of patient L.: Hemoglobin level - 135 g / l, erythrocytes - 4.7 × 10 ¹² / l, white blood cells - 7.8 × 10 ⁹ / l, ESR - 9 mm / h, platelets - 236 × 10 ⁹ / L, AlAT - 15 units / L, AsAT - 16 units / L, alkaline phosphatase - 210 units / L, GGTP - 31 units / L, total bilirubin - 12 units / L, cholesterol - 6.8 mmol / L.

Bacteriological examination of feces for dysbiosis. Conclusion: dysbiosis of the 2nd degree.

Ultrasound of the abdominal organs: dense, heterogeneous bile, biliary sludge (cholelithiasis, stage 1).

FGDS - superficial gastritis of the antrum, duodenitis. Conclusion: Based on complaints, examination and clinical and laboratory data, patient L. has chronic calculous cholecystitis, stage 1 cholelithiasis. Chronic gastritis, chronic duodenitis, exacerbation. Dysbacteriosis of the 2nd degree.

For 24 weeks, the patient received Mukofalk therapy with 1 sachet 3 times a day before meals, after diluting in 1 glass of liquid.

After treatment - weakness, nausea, abdominal pain do not bother. The chair is regular every day.

At the time of inspection: satisfactory condition, clear consciousness. The skin and visible mucous membranes of normal color, clean. Pulse 75 beats per minute, rhythmic, satisfactory filling and tension. Blood pressure - 135/80 mm Hg With auscultation of the heart - tones are muffled. When examining mild pathological changes were not detected. The abdomen is of the correct form, increased in volume due to subcutaneous fat, BMI - 26.1, palpation is soft, painless. Liver on the edge of the costal arch. Ascites is not detected. Rumbling is painless. No peripheral edema.

Clinical and laboratory tests after treatment of patient L.: Hemoglobin level - 136 g / l, erythrocytes - 4.8 × 10 ¹² / l, white blood cells - 6.8 × 10 ⁹ / l, ESR - 8 mm / h, platelets - 230 × 10 ⁹ / L, AlAT - 14 units / L, AsAT - 16 units / L, alkaline phosphatase - 208 units / L, GGTP - 29 units / L, total bilirubin - 11 units / L, cholesterol - 5.9 mmol / L.

Bacteriological examination of feces for dysbiosis; Conclusion: violation of intestinal microbiocenosis was not detected.

Ultrasound of the gallbladder: no pathology detected.

Conclusion: Based on complaints, examination, and clinical and laboratory data in patient L. Chronic gastritis, without exacerbation. The condition remained stable for 3 months after discontinuation of the drug.

Example 2. (prototype - Ursosan)

A / c 1-1978, Patient K., 48 years old, 04/18/2011

Complaints: general weakness, nausea, pain in the right hypochondrium of a aching character.

From the anamnesis it is known that he considers himself sick for 4 months, when, after an error in the diet, nausea appeared, aching pains in the epigastric region. Three days ago, after an error in the diet, pain in the right hypochondrium intensified, there was a single vomiting.

Objectively: the condition is satisfactory, the consciousness is clear. The skin and visible mucous membranes of normal color, clean. Pulse 78 beats per minute, rhythmic, satisfactory filling and tension. Blood pressure - 130/80 mm Hg With auscultation of the heart - tones are muffled. When examining mild pathological changes were not detected. The abdomen is of the correct form, increased in volume due to subcutaneous fat, palpation is soft, painful in the right hypochondrium and epigastrium, a positive symptom of Kera, BMI - 30.0. Liver on the edge of the costal arch. Ascites is not detected. Rumbling is painless. No peripheral edema.

Clinical and laboratory tests during the treatment of patient K.: Hemoglobin level - 116 g / l, erythrocytes - 4.0 × 10 ¹² / l, white blood cells - 5.9 × 10 ⁹ / l, ESR - 14 mm / h, platelets - 237 × 10 ⁹ / L, AlAT - 18 units / L, AsAT - 14 units / L, alkaline phosphatase - 225 units / L, GGTP - 32 units / L, total bilirubin - 12 units / L, cholesterol - 6.6 mmol / L.

Bacteriological examination of feces for dysbiosis. Conclusion: dysbiosis of the 2nd degree.

Ultrasound of the abdominal organs: dense, heterogeneous bile, biliary sludge (cholelithiasis, stage 1).

FGDS: superficial gastritis, cardia failure, duodenogastric reflux.

Conclusion: Based on complaints, examination and clinical and laboratory data, patient K. has chronic calculous cholecystitis, stage 1 cholelithiasis. Chronic gastritis, exacerbation. Dysbacteriosis of the 2nd degree.

For 24 weeks, the patient received therapy with Ursosan 15 mg / 1 kg of body weight, once a night.

After treatment, while taking the drug, Ursosan notes the appearance of nausea, unstable loose stools up to 3 times a day.

At the time of inspection: satisfactory condition, clear consciousness. The skin and visible mucous membranes of normal color, clean. Pulse 84 beats per minute, rhythmic, satisfactory filling and tension. Blood pressure - 130/80 mm Hg With auscultation of the heart - tones are muffled. When examining mild pathological changes were not detected. The abdomen is of the correct form, with palpation it is soft, painless in the right hypochondrium and epigastrium, BMI - 31.4. Liver on the edge of the costal arch. Ascites is not detected. Rumbling is painless. No peripheral edema.

Clinical and laboratory tests after treatment of patient K.: Hemoglobin level - 118 g / l, erythrocytes - 4.1 × 10 ¹² / l, white blood cells - 5.8 × 10 ⁹ / l, ESR - 11 mm / h, platelets - 236 × 10 ⁹ / L, AlAT - 19 units / L, AsAT - 16 units / L, alkaline phosphatase - 222 units / L, GGTP - 30 units / L, total bilirubin - 10 units / L, cholesterol - 6.5 mmol / l.

Bacteriological examination of feces for dysbiosis: conclusion: dysbiosis of the 2nd degree.

Ultrasound of the gallbladder: no pathology detected.

Conclusion: Based on complaints, examination, and clinical and laboratory data, patient K. has chronic gastritis, without exacerbation. Intestinal dysbiosis 2nd degree.

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

25 patients with stage 1 gastrointestinal disease (biliary sludge) were examined. All patients were divided into 2 groups:

Group 1 - 15 people with cholelithiasis of the 1st stage. The treatment program included taking the drug from the group of laxatives in combinations (Mukofalk), 1 sachet 3 times a day, the duration of administration was 22-24 weeks.

2 group - (prototype) - amounted to 10 people with cholelithiasis of the 1st stage. The treatment program included taking a hepatoprotector from the group of ursodeoxycholic acid with a litholytic effect (Ursosan), 15 mg per 1 kg of body weight, once a night, for 24 weeks.

The survey included:

1. Clinical and biochemical analysis of blood;

2. Bacteriological examination of feces for dysbiosis;

3. Ultrasound of the abdominal cavity;

4. FGDS.

An ultrasound study revealed biliary sludge in all 25 patients (100%), which corresponds to stage 1 cholelithiasis. Patients presented the following complaints: abdominal pain, often monotonous, in the right hypochondrium; stool disorders; nausea with a saved appetite. However, when examined, 12 people (34.3%) had no clinical manifestations. Tables 1 and 2 present the results of clinical and laboratory studies of clinical and biochemical blood parameters, bacteriological analysis of feces for dysbacteriosis, clinical symptoms, ultrasound data.

As can be seen from the tables (12), the claimed method is not inferior in its effectiveness to the prototype method for resolving biliary sludge, but is devoid of the disadvantages that are inherent in the prototype.

Thus, the claimed method expands the arsenal of drugs with a litholytic effect used in patients with stage 1 cholelithiasis and is free from side effects exerted by the prototype, such as diarrhea, nausea, abdominal pain, calcification of gallstones, increased activity of liver transaminases.

The method was developed and tested in 15 patients with stage 1 cholelithiasis at the Department of Internal Medicine and Nephrology of the North-West State Medical University. I.I. Mechnikova.

Table 1 The dynamics of clinical and laboratory parameters during therapy Indicators Group No. 1 (Mukofalk) R Group No. 2 (Ursosan) R BEFORE treatment After treatment BEFORE treatment After treatment Hemoglobin, g / l 135 136 <0.05 116 118 <0.05 Red blood cells, × 10 ¹² / l 4.7 4.8 <0.05 4.0 4.1 <0.05 White blood cells × 10 ⁹ / L 7.8 6.8 <0.05 5.9 5.8 <0.05 ESR, mm / h 9 8 <0.05 fourteen eleven <0.05 Platelets × 10 ⁹ / L 236 230 <0.05 237 236 <0.05 AlAT, units / l fifteen fourteen <0.05 eighteen 29th > 0.05 AsAT, units / l 16 16 <0.05 fourteen 27 > 0.05 Alkaline phosphatase, units / l 210 208 <0.05 225 222 <0.05 GGTP, units / l 31 29th <0.05 32 thirty <0.05 total bilirubin, units / l 12 eleven <0.05 12 10 <0.05 Cholesterol, mmol / L 6.8 5.9 > 0.05 6.6 6.5 <0.05 Bifidobacteria 10 ^{6 September} 10th > 0.05 May ¹⁰ 10 ⁶ > 0.05 Lactobacilli May ^{10 July} 10th <0.05 10 ⁶ 10 ⁶ <0.05 Bacteroids 10 ⁴ 10 ⁴ <0.05 May ^{10 July} 10th > 0.05 E. coli normal. enzyme. assets. May ^{10 July} 10th > 0.05 10 ⁶ 10 ⁶ > 0.05 E. coli co reduced. enzyme. assets March ¹⁰ 10 ⁶ <0.05 ^February 10th ^February 10th > 0.05 Enterococci May ¹⁰ 10 ⁶ > 0.05 ^February 10th ^February 10th > 0.05 Candida mushrooms 10 ⁴ March ¹⁰ <0.05 10 ⁴ 10 ⁴ <0.05 BMI 27.6 26.1 > 0.05 30,0 31,4 <0.05 Abdominal pain,% 40 6.7 > 0.05 thirty fifty <0.05 Nausea,% twenty 0 > 0.05 twenty fifty <0.05 Diarrhea,% 6.7 0 > 0.05 10 40 <0.05 Constipation,% 23.3 0 > 0.05 60 60 <0.05

table 2 Dynamics of resolution of biliary sludge according to ultrasound Ultrasound of the gallbladder Study time 1 group n = 15 (Mukofalk) 2 group n = 10 (Ursosan) Presence of biliary sludge Originally + (100%) + (100%) In 24 weeks - (0%) - (0%)

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Claims (1)

A method of treating patients with cholelithiasis of the first stage, which consists in medication, characterized in that the patient is administered Mukofalk, at a dose of 1 sachet 3 times a day for 22-24 weeks.