The prevalence of inflammatory bowel disease (IBD) (ulcerative colitis (UC) and Crohn's disease (CD)) increases annually. The problems of early and non-invasive diagnosis of IBD remain relevant. The purpose of this review is to analyze the diagnostic value of various biological markers of IBD. The main objective of the search for new biomarkers of IBD is to minimize the possibility of repeated endoscopic studies for early diagnosis and determination of disease activity, evaluation of the effectiveness of treatment and prevention of complications. Widely used, routine, and also perspective biological markers allowing to verify the diagnosis of IBD, to estimate a course and a prognosis of a disease are presented.

The study involved 57 patients with GERD, of whom 26 (45.6%) men and 31 (54.4%) women. The average age of patients is 51.4 ± 8.6 years. Among patients with GERD, the typical course of the disease was observed in 49 people (84.7%), atypical - in 8 people (15.3%). Among atypical manifestations of GERD, cardiac prevailed: 5 people (8.8%) noted the appearance of postprandial chest pain, 2 (3.5%) had complaints of palpitations and interruptions in heart function. In one patient, the clinical manifestation of GERD had a "coma in the throat." According to the endoscopic examination, esophagitis was detected in 9 patients (15.3%). Catarrhal esophagitis was diagnosed in 7 (11.9%) patients, erosive - in 2 (3.4%). The article presents an assessment of the nature of changes in vegetative and temporal parameters of heart rate variability (HRV) over a long period of time in patients with gastroesophageal reflux disease (GERD), describes their dependence on the nature of the predominant reflux, the average daily value of intraesophageal pH, exposure time of acid gastroesophageal reflux, reflux index. Women suffering from GERD are 5.4% higher (p=0.01) than men in the arithmetic mean of the RR intervals, which may indicate a relatively higher risk of various kinds of arrhythmias. Also significantly higher in women were the average values of such indicators as the adequacy of the processes of regulation and the voltage index of regulatory systems by 15.2% (p=0.04) and 24.0% (p=0.04), respectively, indicating a greater impact on the sinus node of the sympathetic division of the vegetative nervous system.

The article presents the results of the study assessing the role of thyroid dysfunction and cytokine imbalance in the pathogenesis and manifestations of irritable bowel syndrome (IBS). We have found low serum triiodothyronine (T3) levels as well as normal or mildly reduced serum TSH levels in 44.78% IBS pts, thus confirming the presence of euthyroid sick syndrome. These changes in thyroid hormone levels were more frequent in IBS with constipation. Moreover, the IBS group was found to have elevated mean anti-TPO levels as compared with the controls. Thyroid imbalances were associated with moderately elevated pro-inflammatory (TNF-α, IL-1ß, IL-6, IL-8) cytokine levels and low levels of serum anti-inflammatory IL-10 cytokine as compared with the healthy subjects. Along with this, hypercytokinemia was less pronounced in IBS than in ulcerative colitis (UC). We have revealed relationship between clinical manifestations of IBS and the severity of thyroid dysfunction. Positive correlation was found between T3, free T4 and IL-8, while anti-inflammatory IL-10 cytokine was negatively correlated with free T3 levels. Our findings suggest that thyroid dysfunction and regulatory cytokines play a significant role in the pathogenesis and manifestations IBS and can be considered as an objective markers of disease severity. .

The aim. To assess the significance of somatotype and eating behaviour for evaluation of obesity risk resulting in the development of chronic cholecystitis in men and women. Materials and methods used: The 301 patients (97 men and 204 women) suffering from chronic cholecystitis were under medical observation. The impact of somatotype and eating behaviour on obesity risk and its further development into chronic cholecystitis in men and women was analyzed. Results. 62.8% of men and 79.9% of women suffering from obesity were reported to also suffer from chronic cholecystitis, while calculous cholecystitis burdened with obesity was registered more frequently in women rather than men - 88.5% and 59.1% respectively. The increased risk of chronic cholecystitis as a result of obesity in women was proved to be associated with significant frequency of metabolic syndrome with carbohydrate metabolism disorder prevailing. Conclusion. Results of survey have proven that frequency of obesity occurrence in men of abdominal, abdominal-muscular and abnormal constitutional types doesn’t almost depend on their eating behaviour while emotional eating behaviour in men of muscular-abdominal and muscular-thoracic constitutional types is an adverse prognostic factor for obesity progression and its further development into cholecystitis. The risk of obesity and resulting chronic cholecystitis in women is mostly associated with megalosomal constitution regardless of their eating behaviour type while external and emotional eating behaviours in women of other constitutional types are considered significant risk factors.

The aim of the study was to investigate the pathogenetic and diagnostic significance of changes in the concentrations of lipopolysaccharide-binding protein (LBP) and the Soluble Cluster of Differentiation 14 (sCD14) in plasma of the blood in chronic hepatitis (CH) and liver cirrhosis (LC). Materials and methods: 54 patients with CH and 120 with LC was included in the study. Control group (CG) - 30 practically healthy donors. The concentration of LBP and sCD14 was studied in EDTA plasma by enzyme immunoassay using a commercial test - HyCult biotechnology systems (Netherlands). The study of the organs of the abdominal cavity and pulse dopplerography with color flow Doppler mapping of vessels were performed on an Ultrasound Monitor "Logic-500" (USA) with a 3.5-MHz convection sensor. Results: The mean values of LBP and sCD14 in CH and LC were significantly higher than in CG and did not differ significantly depending on the etiology of the disease. The concentration in the blood of LBP and sCD14 was influenced by the activity of CH and LC, the severity of portal hypertension and associated clinical manifestations, hepatic encephalopathy, the Child's Pugh class of severity. Reliable relationships between the studied parameters and a number of diagnostically significant ultrasound parameters of the portal blood flow (PBF) have been established. Conclusion: The study of the blood levels of LBP and sCD14 in CH and LC can be used to diagnose endotoxemia syndrome, the degree of activation of the anti-endotoxin immune response. Determination of the concentration of LBP in combination with the leading ultrasound parameters of the PBF contributes to the clarification of the degree of severity of the pathological process in the liver, allows predicting the transformation of CH to LC.

The aim of this study was assessment of the structural and functional state of the liver in patients with non-alcoholic fatty liver disease (NAFLD) with excessive body weight and obesity of I - II degree. The study included 120 patients with NAFLD (45 to 65 years old) with diabetes mellitus type 2. Depending on the body mass index, patients were divided into four groups, comparable by sex, age, severity of chronic heart failure (myocardial infarction from 6 to 12 months earlier). Patients were examined by standard clinical and anthropometric methods, assessment of visceral obesity with bioimpedanceometry and a calculation method. Level of functional status and markers of hepatocyte damage were studied by the biochemical blood test according to standard laboratory methods. Structural state of the liver was evaluated according to ultrasound data and with calculated indices of steatosis and fibrosis of the liver. The results of the study showed that as the body mass index increases, a significantly higher incidence of hyperfermentemia transaminases and gamma glutamyltranspeptidase is determined. The level of visceral adiposity and fatty tissue dysfunction in patients with NAFLD significantly correlated with the severity of cytolysis and cholestasis, decline of bilirubinemia. Patients with heavier structural changes in the liver, both from ultrasound data and from computational methods, are prevailed among patients with obesity. In conclusion: an increase of the severity of obesity, including visceral obesity, the severity of visceral fat dysfunction in patients with NAFLD is accompanied by an increase in structural and functional disorders in the liver.

Objective: To study the indicators of cellular renewal of the colon mucosa in non-alcoholic fatty liver disease (NAFLD). Materials and methods: 138 people with NAFLD and intestinal pathology were examined. The indices of proliferation (Ki-67) and apoptosis (Bcl-2) in comparison with clinical, endoscopic features of the colon and morphometric features of colonocytes expression immunopositive to leptin and the factor of vascular endothelial growth were studied. Results: It was found that changes in the intestinal mucosa and liver in NAFLD are associated with changes in the parameters of the cellular renewal of epithelial cells (the colon proliferation marker is Ki-67 and the marker of apoptosis colonocytes is Bcl-2) with changes in the production of leptin and the vascular endothelial growth factor.

The purpose of the study: optimization of diagnosis and treatment of patients with ulcerative colitis by selecting rational antibacterial therapy based on the results of microbiological examination of the microflora of the wall of the colon. Materials and methods: 35 patients with ulcerative colitis aged from 28 to 61 years who were on outpatient and inpatient treatment at the departments of coloproctology and gastroenterology of the SamSMU Clinic were examined. Collection of biopsy material of ulcerative defects of the mucous membrane of the large intestine was performed during the fibrocolonoscopy, and a pure culture of microorganisms was isolated from biopsy material using classical methods. The isolated cultures were identified using MALDI-TOF mass spectrometry. All the isolated cultures were sensitive to antibiotics by a disco-diffusion method. Results: In assessing the quantitative composition of the isolated microflora in patients with mild disease, the microflora in the wall of the colon was absent, or low titers of the sown strains (10²-10³ CFU per biopsy) were determined. In patients with an average severity and severe course of the disease in 50.0% and 53.8% of cases, respectively, a pronounced microbial contamination of the submucosal layer (the number of microorganisms 105-106 CFU per biopsy), a wide variety of species. When analyzing sensitivity to antibiotics of isolated strains, it was found that 45% of them have resistance to 1-2 groups of drugs, 33% have resistance to 3 or more groups. Only 22% of the strains were sensitive to all tested drugs. Conclusion: The eradication of a resistant flora is complex and, from our point of view, pathogenetically substantiated and requires the appointment of a combination therapy after microbiological examination of the biopsy specimen.

The role of comorbidity in the treatment of liver cirrhosis (LC) and its complications is unknown. Purpose: studying of comorbidity in patients with LC and its impact on outcome of the disease. Materials and methods. 155 patients (women - 49,4%, men - 50,6%, mean age 52,15±12,41) were follow up for 3 year. Viral LC was diagnosed in 33.8%, alcohol LC - 22,1%, autoimmune LC-15, 6%, other causes and cryptogenic causes noted in - 28,5%. More than half of the patients had a class В of Child-Pugh (51.9%). Comorbidity was determined by Charlson and CirCom (Jepsen, 2014) scales. Results: during 3 year of observation 44 people died (28,4%): 33 (75%) patients died from LC complications; 11 (25%) patients died from causes not directly related to LC (4-cancer, 2-diabetes mellitus (DM), 1-trauma, 1-atrial fibrillation, pulmonary embolism-1, stroke-1). 44 patients (28,4%) had no comorbidities. Hypertension was noted at 26.6%, cholelithiasis - 22.1% and DM-14.9%. 41.9% of patients had 1 concomitant disease, 18.7% - 2 diseases, 10.9% - more than three. The number of comorbidities significantly increased the risk of death from causes unrelated to LC (RR: 5,000; 95% CI: 1,426-17, 532). Bilateral positive correlation (rs=0,304, p=0,00012) between the age of patients and the number of comorbidities was revealed. The analysis of the relationship between Charlson and CirCom scales confirmed their correlation at rs=0,543, p=0,0000001. Statistically significant differences of Charlson and CirCom comorbidity were found in groups of patients who died from causes unrelated to LC and lived to the end of the follow-up period (p*=0.000048, p**=0.000243).

The aim of the research: to establish diagnostic and prognostic values of chromosomal aberrations in the gene of vitamin D receptors in the combined course of chronic pancreatitis and arterial hypertension. Materials and methods: For this research, two groups of patients were created - the main one - 70 patients with chronic pancreatitis and arterial hypertension and a comparison group - 40 persons with isolated course of chronic pancreatitis. Results: The prevalence of B-allelic polymorphism of this gene was established. The comorbidity of chronic pancreatitis and arterial hypertension in 51.4% of cases occurs against the pathological (ВВ-genotype) polymorphism of the VDR gene, which means early development of complications. With В-allelic polymorphism of the VDR gene, favorable conditions for the development of osteopenic conditions (32.9%) are created, which causes their early diagnosis and treatment.

The purpose: to study the peculiarities of motor and evacuation functions of the stomach and duodenum in patients with peptic ulcer with associated chronic duodenal insufficiency (СDI). Materials and methods. The complex examination was carried out by 160 patients with ulcer disease (UD) with concomitant CDI (group 1) and 104 patients with no concomitant CDI (2nd group). The verification of UD was carried out by clinical and fibrogastroduodenoscopy studies. In the definition of CDI contrast duodenography and fibrogastroduodenoscopy were used. The evaluation of the motor-evacuation function (MEF) of the stomach and duodenum was carried out with the help of the peripheral electrogastroenterograph. Results of the study. In patients with UD with associated HDI before meals were identified bradygastria (75%) and hypertension (67%) of the stomach, and after eating the parameters of the electrical activity of the stomach in frequency and amplitude were decreased. We revealed hypokinesia (74%) and hypertension (52%) of duodenum on an empty stomach, postprandial frequency of it decreases compared with a thorough examination. The duodenogastric reflux is revealed in the fasting phase of the study. A segmenting and peristaltic contractions of the duodenum are slowed down, which is manifested in a decrease in the evacuation function of stomach and duodenum. Before meals in patients with UD without accompanying HDI were identified hypertension of the stomach (15%) and duodenum (68,95%), after a meal the indices of electrical activity of the stomach and duodenum were increased. In patients with duodenum ulcer of 1 group the electrical activity of duodenum before meals was corresponded to hyperkinetic (98.2%) and hypertensive (62.3%) type of the curve. The eating in patients of this group increases the peristaltic contractions of the longitudinal muscle layer of the duodenum, thereby accelerating the evacuation of the chyme without mixing it and disrupting the digestion process. In patients with duodenal ulcer without accompanying HDI before meals were identified the hypertension of the stomach (15%) and duodenum (68.95%), coordinated work of stomach and duodenum, as well as evacuation of food chyme were preserved. The conclusion. In patients with ulcer disease of stomach and duodenum with accompanying duodenal insufficiency, there was a violation of motor and evacuation activity of the stomach and duodenum both on an empty stomach and after eating, which adversely affects the course of ulcer disease.

Aim. Analysis of gastroenterological adverse events of rheumatoid arthritis (RA) pharmacotherapy and measures for their prevention and correction. Materials and methods. An open pharmacoepidemiological prospective study was conducted based on the analysis of 230 medical records of patients with diagnosis of RA in the specialized department. Results of the study. Adverse events from the digestive system were developed in 52,2% patients taking disease-modifying antirheumatic drugs (DMARDs). The largest number of adverse events were registered for the methotrexate use. The average dose of methotrexate that led to adverse events was 15±7,1 mg per week. Correction of folate deficiency with the use of methotrexate was performed only in 84,4% of patients. NSAIDs-gastropathy was developed in 25,5% cases using of nonsteroidal anti-inflammatory drugs (NSAIDs)/ All patients taking NSAIDs and/or glucocorticosteroids received proton pump inhibitors. Conclusion. For the treatment of RA used DMARDs, NSAIDs, glucocorticosteroids. Adverse events are developing in most patients. Most often adverse events occured from the digestive system.

The aim of the research was to assess the severity of hepatocyte apoptosis in early form of non-alcoholic fatty liver disease (NAFLD) - liver steatosis (LS). Materials and methods. Total of 83 patients of LS were examined: men 42 (50.6%), women - 41 (49.4%) at the age of 52.4 ± 12.3 years. The diagnosis of the LS was established on the basis of clinical, laboratory data, the results of ultrasound liver examination and histological examination of liver biopsy specimens. Blood plasma levels of cytokeratin-18 (CK-18) (apoptosis marker) («TPS ELISA test system», Biotech, Sweden), tumor necrotic factor alpha (TNF-α) («Human TNFα Platinum ELISA test system», "EBioscience", Austria), insulin («Insulin TEST system», USA) were examined by ELISA. The HOMA index, the NAFLD fibrosis score (NAFLD FS) were calculated. The histological activity and fibrosis were evaluated using the Brunt method. Statistics were analyzed using the "StatGraphics 2.1" , using the Mann-Whitney U test, Spearman's rank correlation analysis. Results. High content of CK-18 was found in patients with hepatic steatosis compared with that in healthy individuals - 184.4±64.6 U/l versus 90.1±37.2 U/l (p=0.030). A significant increase of laboratory markers of intrahepatic cholestasis, HOMA-IR, TNF-α, cholesterol, low-density lipoproteins, triglycerides, glucose and NAFLD FS were revealed in patients with liver steatosis relative to the control. The level of CK-18 correlated only with cholesterol in LS - r=+0,70 (p=0,004). Conclusion. An increased CK-18 level of hepatocyte apoptosis marker was detected in an early form of NAFLD - liver steatosis, indicating the risk of progression of this disease. The close relationship between the content of CK-18 and the level of cholesterol in the blood confirmed the role of the latter in the development of hepatocyte apoptosis. Therapy is aimed at arresting hepatocyte apoptosis and normalization of cholesterol levels, appropriate for the earliest form of NAFLD - liver steatosis.

Therapy of glucagon-like peptide 1 receptors agonists (aGLP1) liraglutide within 24 weeks led to considerable weight reduction, a circle of a waist, HbA1c, TG, AST and increase in HDLP at patients with type 2 diabetes mellitus (2TDM) and multiple manifestations of metabolic syndrome (obesity, dyslipidemia, hypertension) in real clinical practice. Effects of therapy liraglutide on the markers of fibrosis and a scale estimating risk of its progression were ambiguous and depended on various predictors. Decrease in the index of fibrosis on therapy aGLP1 depended on a floor and extent of increase in HDLP. Dynamics galectin-3 depended on weight reduction and its significant decrease is noted only at patients with loss weight ≥ 5%. Initial levels of incretin (GIP and GLP1) acted as predictors of decrease in PIIINP. Further researches on big cohorts of patients with obesity, a metabolic syndrome and 2TDM are necessary for definition of groups of the patients capable it is essential to reduce risk of a progression of fibrosis on therapy aGLP1

Methods of retrospective analysis analyzed the case histories of 85 patients that hospitalized in the pulmonology department of the Saratov City Clinical Hospital No.8 in 2015-2017 with sarcoidosis of the intrathoracic lymph nodes and lungs. Pathology of the gastrointestinal tract was detected in 28% of cases. The most frequent disease was chronic gastroduodenitis, in the most cases it was asymptomatic. The revealed pathology of the gastrointestinal tract was not associated with drug therapy of sarcoidosis of the intrathoracic lymph nodes and lungs. Perhaps the described combinations can be considered as a manifestation of the comorbidity of diseases of the gastrointestinal tract and bronchopulmonary system.

Purpose of the study. To assess the severity of endogenous intoxication in mechanical jaundice and to study the detoxification effect of the ozonized saline solution. Materials and methods. There were studied the results of surgical treatment of 76 patients with mechanical jaundice, divided into 2 groups. Patients in the group 1 (n = 40) underwent conventional treatment. 36 patients of the 2nd group were treated with ozonized saline solution. The following were determined: aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT); common and direct bilirubin, average weight molecules (AMM), malonicdialdehyde (MDA), catalase, creatinine and urea concentration in plasma. Results. On the 15th day of the postoperative period, the levels of ALAT, AMM, MDA, creatinine, urea were decreased in patients of group 1 by 33, 36, 38, 30 and 38% respectively, the level of catalase increased by 32%. In patients of the 2nd group, the levels of ALAT, AMM, MDA, creatinine and urea decreased by 59, 56, 61, 35, 55%, whereas the catalase level increased by 65%. The conclusion. The therapy with ozonized saline solution promotes the decrease of the level of endogenous intoxication due to more pronounced activation of antioxidant system with a decrease of the level of free radical oxidation and of destructive processes in the liver.

Objective: to determine the prognostic value of the complex assessment of the patient's condition (clinical examination using scales, biochemical markers, dynamic ultrasound and CT) for the timely formulation of indications for surgery in the development of purulent complications of pancreatonecrosis in the phase of septic sequestration. Material and Methods: the study included 186 patients with pancreatic necrosis. The comparison group included patients whose manifestations of the disease were limited to the development of enzymatic peritonitis. The second group includes patients who have formed peripancreatic infiltrate and (or) isolated pancreatogenic abscess. The third group consisted of patients with purulent-necrotic parapancreatitis. Results: Measurements on the SAPS III scale revealed a significant difference of scores in patients with purulent necrotic parapancreatitis and patients in the comparison group. Similar data were obtained from a comparative assessment of the severity of organ failure on the SOFA scale. The study showed a significant decrease in the serum albumin level in patients with purulent-necrotic parapancreatitis and the presence of a significant difference in this parameter with patients in the comparison group. Conclusion: With purulent-necrotic parapancreatitis, a complex assessment of the patient's condition helps timely recognize infectious complications and formulate the indications for surgical intervention. In patients with limited infected pancreatic necrosis, the use of scales and biochemical markers was not very informative.

The purpose of this study was to study the quality of life of patients with chronic pancreatitis. An original questionnaire on the quality of life of patients with chronic pancreatitis was proposed and tested. Materials and methods: 38 operated and 40 non-operated patients with chronic pancreatitis were examined. Results. A high degree of conceptual, constructive and criterial validity, internal consistency and reproducibility of the original questionnaire scales is proved. A strong correlation was found between rs> 0,71 of the scale of digestive disorders with the severity of malabsorption syndrome (p <0.001). The proposed COLPAC questionnaire can be used for diagnostic purposes and for an individual assessment of the clinical symptoms of chronic pancreatitis. The questionnaire can serve as a reliable tool for assessing the quality of life of patients operated on for chronic pancreatitis.

Fine needle puncture under the control of endoscopic ultrasonography is a high-tech method of morphological verification of the diagnosis. This article is devoted to the review and analysis of the possibilities of fine needle puncture under the control of endosonography in the morphological verification of pathologically altered adrenal glands. The aim of the study was to explore the possibilities of fine-needle puncture under the control of the endoscopic ultrasonography in the morphological verification of space-occupying lesions of the adrenal gland. Materials and methods: the study included 59 patients who underwent endoscopic ultrasonography in the period from 2007 to 2018, 39 of them underwent fine needle puncture for morphological verification of the diagnosis. Results: to solve the tasks - morphological verification of the diagnosis in 39 patients 45 fine - needle punctures were performed, 34 (75.6%) of them were performed once, in 4 (8.8%) cases it was performed twice, in 1 (2.2%) - three times. Of the 44 performed fine-needle punctures in 4 (9.1%), its results were uninformative. The informativeness of EUS-TYPE for morphological verification was 90.9%. Complications of various kinds were not recorded Conclusion: thus, endoscopic ultrasonography in our study has demonstrated itself as a high-precision method of examination of patients, allowing to visually identify and confirm tumor changes in the adrenal glands. Taking into account the resolution of this method and the proximity of the adrenal gland to the echoendoscope sensor, performing a fine-needle puncture is the best way to obtain material for morphological verification of the diagnosis. The combination of the advantages of the method in the possibility of visualization and the minimum distance to the object of fine-needle puncture allow us to recommend this method as the main if necessary morphological verification of changes in the adrenal glands.

The remaining disorders of stool, supposedly of a functional nature, similar to the symptoms of irritable bowel syndrome (IBS), in patients with inflammatory bowel disease (IBD) in remission during the last 16 years are actively discussed in the literature. A great similarity in the clinical manifestations and mechanisms of the formation of true IBS and IBD-IBS was revealed. As the combining factors of these two pathological conditions, occult inflammation in the intestinal wall, intestinal motility disorders, visceral hypersensitivity, intestinal microbiome disorder and increased permeability of the mucosa are considered. The role of psychological stress in the formation of the IBD-IBS remains underestimated and insufficiently investigated. In patients with true IBS and IBD-IBS, the indices of depression, actual and personal anxiety, alexithymia are statistically significantly higher than in healthy individuals and do not differ among themselves. An additional confirmation of similar changes in the psychovegetative status in patients with IBS and IBD-IBS is the study of one of the relatively new psychometric indicators, the Visceral Sensitivity Index (VSI), which characterizes specific anxiety with respect to gastroenterological symptoms of the disease. An integrative index of all psycho-vegetative changes in patients is an indicator of the quality of life. As in patients with true IBS, and with IBD-IBS, according to the literature, Noah decrease in both physical and mental QOL component. The article deals with modern information about similarities and differences mechanisms of IBS and IBD in remission with IBS-like symptoms, which indicate large differential diagnostic difficulties in distinguishing these disorders.

Purpose of the study: Investigation and comperasion of dissolution kinetics of three mebeverine hydrochloride drugs: Duspatalin® 200 mg prolonged-release capsules, Niaspam 200 mg prolonged-release capsules and Sparex® 200 mg prolonged-release capsules. Materials and methods: For each of mebeverine trade names under test, a total of 6 prolonged-release capsules 200 mg were used in the experiment. Duspatalin® 200 mg, served as a reference product. The study was performed using three dissolution media (рН 1.2; 4.5; 6.8), which modeled GI tract parts where disintegration, release, and absorption of API take place. Sampling points (1, 2, 4, 6, 8, 10, and 12 hours) were selected in such a manner so the dissolution profile of the studied dosage forms would be fully described, including the complete release (the plateau). Results: The dissolution kinetics of generic drugs (Niaspam 200 mg and Sparex® 200 mg prolonged-release capsules) and reference product were found to be equivalent in vitro in media with pH 1.2 and 6.8. At the same time, the dissolution of these drugs was not equivalent at media with pH 4.5, which is characteristic for the stomach antrum. The results of the comparative study show that at pH 4.5 93.66% of the API was released from Niaspam capsules and 98.72% - from Sparex® capsules. The percentage of released API from Duspatalin® capsules was 83.08%. Conclusion: In vitro laboratory studies of mebeverine hydrochloride release rate from three drugs (Duspatalin® 200 mg prolonged-release capsules, Niaspam 200 mg prolonged-release capsules and Sparex® 200 mg prolonged-release capsules) showed that the dissolution kinetics at pH 4.5 of the generic drugs differs from that of the original drug, which may potentially impact on clinical practice. However, further direct comparative clinical studies are required in order to confirm this hypothesis.

This review focuses on the clinical picture, approaches to the diagnosis and treatment of cholelithiasis.