As one of the first Direct Acting Antivirals (DAA), the protease inhibitor Telaprevir (TVR) was available in the European Union from 9/2011 until 9/2016 as a new treatment option for chronic Hepatitis C.

Aim. To assess the implementation of therapy stopping rules or shortening of the treatment and their impact on sustained virological response (SVR), as well as the safety and efficacy of the TVR-based therapy during routine daily treatment of patients in Germany.

Materials and Methods. 802 patients were assessed (272 treatment naïve, 520 pre-treated) in the noninterventional, multi-center study.

Results. 56.6 % of the patients achieved SVR. SVR rate was higher in patients with relapse after previous treatment (68.0 %) than in patients with a previous null-response (31.1 %) and in previously untreated patients (58.1 %). Stopping rule conditions were fulfilled by 3.2 % of patients and it was implemented in 65.4 % of these. 34.3 % of the patients fulfilled the conditions for a therapy shortening. This rule was adhered to in 48.4 % of these, in 34.5 % it was not adhered to. Thus recommendations were not always being followed. Therapy shortening was considered more frequently in previously untreated (54.8 %) than for previously treated patients (24.2 %). Stopping rule application but not shortened treatment reduced therapy costs.

Conclusion. The TVR-based therapy represented a breakthrough at that time. Further DAAs have been added as therapeutic options since, increasing the complexity of treatment choice and correct implementation. They represent both an opportunity and a challenge for all those involved.

As one of the first Direct Acting Antivirals (DAA), the protease inhibitor Telaprevir (TVR) was available in the European Union from 9/2011 until 9/2016 as a new treatment option for chronic Hepatitis C.Aim. To assess the implementation of therapy stopping rules or shortening of the treatment and their impact on sustained virological response (SVR), as well as the safety and efficacy of the TVR-based therapy during routine daily treatment of patients in Germany.Materials and Methods. 802 patients were assessed (272 treatment naïve, 520 pre-treated) in the noninterventional, multi-center study.Results. 56.6 % of the patients achieved SVR. SVR rate was higher in patients with relapse after previous treatment (68.0 %) than in patients with a previous null-response (31.1 %) and in previously untreated patients (58.1 %). Stopping rule conditions were fulfilled by 3.2 % of patients and it was implemented in 65.4 % of these. 34.3 % of the patients fulfilled the conditions for a therapy shortening. This rule was adhered to in 48.4 % of these, in 34.5 % it was not adhered to. Thus recommendations were not always being followed. Therapy shortening was considered more frequently in previously untreated (54.8 %) than for previously treated patients (24.2 %). Stopping rule application but not shortened treatment reduced therapy costs.Conclusion. The TVR-based therapy represented a breakthrough at that time. Further DAAs have been added as therapeutic options since, increasing the complexity of treatment choice and correct implementation. They represent both an opportunity and a challenge for all those involved. 

Aim. In this research, we set out to study organic changes in the heart and blood vessels of obese men suffering from non-alcoholic fatty liver disease (NAFLD) combined with cardiac pathology in the metabolically unhealthy phenotype (MUHP). Another objective consisted in establishing a relationship between liver damage and the pathology of the heart and blood vessels.

Materials and methods. A group of 112 men (male)aged 61.2±1.7 diagnosed with the ischemic heart disease (IHD) and stage 1–3 arterial hypertension (AH) were examined during the stationary treatment in the Republican Clinical Diagnostic Centre (Izhevsk, Russia). The patients were divided into 3 groups according to their body mass index (BMI): 29 men with a BMI under 25 kg/m²(I group); 43 overweight men a BMI over 25 of kg/m²(II group); 40 men with obesity and a BMI above 30 of kg/m²(III group). Laboratory and non-invasive instrumental examinations required for the diagnostics of NAFLD and IHD were carried out, including liver ultrasound and FibroScan elastometry. Other examinations included the measurement of the intra-abdominal adipose tissue (IAT) and epicardial adipose tissue (EAT) thickness, the calculation of the visceral adiposity index (VAI), the estimation of endothelial dysfunction indicators, as well as the assessment of the structural and functional parameters of the heart and blood vessels.

Results. In obese patients with pronounced NAFLD signs, IAT, EAT and VAI indicators are shown to increase in direct correlation with the parameters of liver steatosis. A relationship is established between the most significant structural and functional indicators of the heart (myocardial mass index, volume of the left atrium), blood vessels (endotheliumdependent vasodilation, the size of the intima-media complex of the common carotid artery) and NAFLD. It is demonstrated that the correlation coefficients grow with the progression of fatty infiltration and liver fibrosis signs.

Conclusions. The results of the study have revealeda connection between the NAFLD presence and the main markers of visceral fat depots (IAT, EAT, VAI), which is shown to increase the risk of cardio-vascular complications in such patients. NAFLD is accompanied by endothelial dysfunction and a change in the most significant parameters of cardiac and vascular remodelling. These parameters manifest the progression of pathological changes in the liver parenchyma, which increases the cardio-metabolic risk in patients with MUHP.

Aim. This study is aimed at investigating the efficacy and safety of alimemazine (Teraligen®) therapy in patients with irritable bowel syndrome (IBS) associated with comorbid mental disorders (distress, anxiety, somatisation and depression).

Materials and methods. During an open-label, non-comparative and non-interventional study, 60 patients diagnosed with the K58 (K 58.0, K58.9) irritable bowel syndrome were observed (12 men and 48 women, average age 39.6 ± 11.1 years) and treated with Teraligen® (alimemazine) with a gradual dose increase from 2.5 to 15 mg per day against the background of the standard symptomatic treatment used for such states. The observational study lasted for 4 weeks. The Four-Dimensional Symptom Questionnaire (4DSQ) was used to assess the dynamics and effectiveness of the treatment in terms of the patients’ mental state, while the “7 symptoms per 7 days” (“7 × 7”) questionnaire was used to assess the dynamics of IBS symptoms and concomitant functional dyspepsia (FD). Both questionnaires were offered to the patients three times: before the start of the treatment and following 2 and 4 weeks of the therapy.

Results. Teraligen therapy along with the standard symptomatic treatment has shown a significant positive dynamics of the patients’ state due to the reduction of such symptoms, as pain and burning sensation in the epigastrium, postprandial fullness, early satiety, abdominal pain before defecation, abdominal distension, impaired frequency and quality of defecation. This is confirmed by a reliable and consistent decrease in the total scores of the “7 × 7” questionnaire, with the scores changing from 19.7 ± 7.1 to 11.6 ± 5.9 and 7.3 ± 5.6 before treatment, on the 14th day (p <0.0001) and on the 28th day of therapy (p <0.0001), respectively. The number of patients reporting no symptoms increased by 18.3 %, indicating a complete reduction of severe disorders. The proportion of patients with the minimal or mild severity of complaints increased by 36.7 % and 8.2 % (from 3.3 % to 40.0 % and from 11.8 % to 20.0 %), respectively. In addition, alimemazine treatment contributed to a statistically significant positive dynamics of the patients’ psychoemotional state. The average level of distress decreased from 14.9 ± 10.0 to 7.5 ± 6.2 (14th day) and to 4.4 ± 5.8 scores (28th day). The number of patients reporting no distress symptoms increased by 49.4 %, reaching 91.1 % (n = 51) on the 28th day of treatment. The mean level of depression decreased from 1.7 ± 2.7 to 0.5 ± 1.2 (14th day) and to 0.5 ± 1.6 (28th day), while the proportion of patients without depression increased by 17.9 % and reached 94.6 % (n = 53). The anxiety level was reduced from 6.0 ± 6.3 to 2.9 ± 4.3 (14th day) and to 1.5 ± 3.8 scores (28th day), and the proportion of patients without anxiety increased by 21.4 % reaching 96.4 % (n = 54) (28th day). The level of somatisation decreased from 13.5 ± 7.3 to 8.7 ± 5.6 (14th day) and to 5.1 ± 4.4 scores (28th day), and the proportion of patients without somatisation increased by 52.9 % and comprised 92.9 % (n = 52) (28th day) (according to the 4DSQ). Most of the patients tolerated alimemazine at a dose of 15 mg/day. In 15 patients, minor adverse reactions were observed; however, no cases of pronounced and severe side effects were recorded. In 4 patients, the treatment was cancelled due to increased drowsiness.

Conclusion. It is shown that the application of alimemazine (Teraligen®) in patients with IBS and concomitant FD associated with comorbid mental disorders (distress, anxiety, somatisation and depression) reduces gastroenterological (somatic) and mental (affective, somatoform) symptoms, improves the patients’ state of health, thus being confirmed as effective and safe.

Aim. In this research, we aim to develop a criterion for differentiating MutYH-associated polyposis from sporadic colon polyps.

Materials and methods. A search for mutations in the MutYH gene was carried out using the PCR, electrophoresis and direct sequencing methods among the following groups of people: 18 patients under 45 years old with more than 100 polyps diagnosed in the large intestine; 86 patients over 45 years old with 4–100 polyps; 150 people of the control group.

Results. Mutations in the MutYH gene were detected in 2 out of 18 patients having more than 100 polyps. Among 86 patients with 4–100 polyps, mutations were found in 10 people having more than 20 polyps. Mutations in the MutYH gene were not detected in patients with 4–19 polyps (p <0.05). The pathogenic significance of the disease development was established not only for biallelic, but also for monoallelic mutations.

Conclusion. For the first time, the lower limit of the polyp number has been established, allowing the MutYH-associated polyposis to be differentiated from sporadic polyps.

Aim. This study is aimed at improving the treatment of patients with the pilonidal sinus (PS) by open wound healing methods.Materials and methods. The study included 54 patients with PS. The main group consisted of 29 patients treated by an open (exposure) management technique and a subsequent vacuum-assisted wound closure therapy. The control group consisted of 25 patients treated with conventional ointment bandages.Results. On the 8th day of vacuum-assisted therapy (VAC-therapy), the areas of granulation tissue were identified in 23 (79.3 %) and 10 (40.0 %) (p = 0.041) cases in the main group and the control group, respectively. Following one month of treatment, complete wound healing was observed in 24 (82.8 %) patients in the main group, with no patients in the control group showing signs of complete healing (p < 0.0001). Cytologically, starting from the 8th day of VAC-therapy, a decrease in inflammation was observed in 24 (82.8 %) patients in the main group, with the wound regenerative processes being recorded on the 16th day in 17 (58.6 %) patients (p < 0.05). The average rate of wound healing in the main group was significantly higher and equal to 2.15 ± 0.15 cm2/day, compared to the value of 0.76 ±0.18 cm2/day in the control group.Conclusion. Vacuum-assisted wound closure therapy is an effective way to stimulate reparative processes during the open management of wounds after the surgical treatment of PS. Aim. This study is aimed at improving the treatment of patients with the pilonidal sinus (PS) by open wound healing methods.Materials and methods. The study included 54 patients with PS. The main group consisted of 29 patients treated by an open (exposure) management technique and a subsequent vacuum-assisted wound closure therapy. The control group consisted of 25 patients treated with conventional ointment bandages.Results. On the 8th day of vacuum-assisted therapy (VAC-therapy), the areas of granulation tissue were identified in 23 (79.3 %) and 10 (40.0 %) (p = 0.041) cases in the main group and the control group, respectively. Following one month of treatment, complete wound healing was observed in 24 (82.8 %) patients in the main group, with no patients in the control group showing signs of complete healing (p < 0.0001). Cytologically, starting from the 8th day of VAC-therapy, a decrease in inflammation was observed in 24 (82.8 %) patients in the main group, with the wound regenerative processes being recorded on the 16th day in 17 (58.6 %) patients (p < 0.05). The average rate of wound healing in the main group was significantly higher and equal to 2.15 ± 0.15 cm2/day, compared to the value of 0.76 ±0.18 cm2/day in the control group.Conclusion. Vacuum-assisted wound closure therapy is an effective way to stimulate reparative processes during the open management of wounds after the surgical treatment of PS. 

Aim. In this paper, we discuss the clinical significance of belching and present a clinical case with the description of the belching differential diagnosis.
Main findings. Belching may be either a physiological or a pathological phenomenon. Pathological belching requires an adequate diagnostic approach in order to clarify the nature of its occurrence. Gastric belching occurs reflexively at the moment of stomach stretching by excess air trapped during swallowing, which initiates the transient relaxation of the lower esophageal sphincter. As a consequence, the swallowed air escapes from the stomach first into the esophagus and then into the throat. Supragastric belching is a phenomenon, in which the air entering the esophagus does not reach the stomach, but rapidly returns to the throat. In this case, unlike aerophagia, the air entering the esophagus is not accompanied by the act of swallowing. Supragastric belching is not a reflex process; rather, it is considered to be a manifestation of behavioural disorders. 24-hour pH-impedancemetry and high-resolution esophageal manometry are highly informative methods for detecting various types of belching (gastric and supragastric), as well as their mechanisms. We present a clinical observation of a 47-year-old patient suffering from supragastric belching and treated by speech therapy under the supervision of a speech therapist.
Conclusion. 24-hour pH-impedancemetry and high-resolution esophageal manometry (also in combination with impedancemetry) provide a complete differential diagnosis of belching and allow the most effective patient management strategy to be selected.

The incidence of Caroli disease is estimated to be 1 case per 1 million people; as a result, there are very few available clinical observations. At the moment, the treatment of Caroli disease is limited to symptomatic therapy and the prevention of complications, as well as to corrective surgery and liver transplantation.
Aim. The aim of this observation is to describe one case of a rare congenital liver disease – Caroli disease – characterised by a segmented non-obstructive fibrocystic dilation of the intrahepatic bile ducts.
Key findings. A 21-year-old woman was hospitalised with the signs of a systemic inflammatory reaction, hepatosplenomegaly, jaundice, portal hypertension, hepatocellular insufficiency, as well as with the manifestations of cytolytic and cholestatic syndromes. At the age of 8, she was diagnosed with a cyst of the bile ducts, which was treated with cystoenteroanastomosis. At the age of 20, in connection with high portal hypertension, portocaval shunting was performed and a mesenteric-caval anastomosis was applied. During the present hospitalisation, an expansion of the intrahepatic bile ducts was revealed by ultrasound and MSCT of the abdominal cavity with contrast, which made it possible to diagnose Caroli disease.
Conclusion. A case of Caroli disease is described, which resulted in continuously recurrent cholangitis and biliary cirrhosis. This state required liver transplantation. Caroli disease should be included in differential diagnosis in patients suffering from the fever of unknown origin and cholestasis syndrome. An early diagnosis of Caroli disease is important for preventing complications, improving the quality of life and increasing the life expectancy of patients suffering from this rare disease.

Aim. This paper presents guidelines on the diagnostics and treatment of eosinophilic esophagitis, which can be used by practitioners in their everyday practice.

Summary. Eosinophilic esophagitis (EoE) is a chronic immune-mediated disease of the esophagus characterized by the symptoms of esophageal dysfunction and a pronounced eosinophilic infiltration of the esophageal mucosa. The EoE diagnostics is based on the clinical manifestations of the disease (dysphagia, food impaction, chest pain regardless of swallowing), as well as on the combination of endoscopic and histological signs. The diagnostic criterion is the eosinophilic infiltration of the esophageal mucosa with an eosinophil density of ≥ 15 per high power field (×400) in at least one of the biopsy specimens (about 60 eosinophils in 1 mm2). Total IgE levels, peripheral blood eosinophilia and skin allergy tests are considered to be additional diagnostic means. Several approaches are used for the treatment of EoE, including proton pump inhibitors (PPIs) and topical glucocorticosteroids (GCS), as well as elimination diets. The choice of therapy should be individualized, with the mandatory assessment of the treatment efficacy after 6–12 weeks using esophagogastroduodenoscopy with biopsy sampling. Endoscopic dilatation should be considered in patients suffering from severe dysphagia due to esophagus stricture.

Conclusion. Increased incidence of EoE predominantly among children and young people, as well as its chronic character requiring long-term maintenance therapy, make EoE a significant issue to the practice of gastroenterology.