[Effectiveness of empirical Helicobacter pylori eradication therapy with furazolidone in Russia: results from the European Registry on Helicobacter pylori Management (Hp-EuReg)].

BACKGROUND: First-line therapy does not always provide a high level of Helicobacter pylori eradication due to the increase of H. pylori resistance to antibiotics; therefore, it remains necessary to identify the most effective rescue treatments. The purpose of this study was to evaluate the efficacy and safety of empirical H. pylori furazolidone-containing regimens. MATERIALS AND METHODS: Adult H. pylori infected patients empirically treated with furazolidone-containing eradication regimens were registered in an international, prospective, multicenter non-intervention European registry on H. pylori management (Hp-EuReg). Data were collected at AEG-REDCap e-CRF from 2013 to 2021 and the quality was reviewed. Modified intention-to-treat (mITT) effectiveness analyses were performed. RESULTS: Overall 106 patients received empirical furazolidone-containing therapy in Russia. Furazolidone was prescribed in a sequential scheme along with amoxicillin, clarithromycin and a proton pump inhibitor in 68 (64%) cases, triple regimens were prescribed in 28 (26%) patients and quadruple regimens in 10 (9.4%). Treatment duration of 7 days was assigned to 2 (1.9%) patients, 10-day eradication therapy in case of 80 (75%) and 14 days - in 24 (23%) patients. Furazolidone was mainly used in first- (79%) and second-line (21%) regimens. The methods used to diagnose H. pylori infection were: histology (81%), stool antigen test (64%), 13C-urea breath test (6.6%), and rapid urease test (1.9%). The mITT effectiveness of sequential therapy was 100%; 93% with the triple therapy and 75.5% with quadruple therapy. Compliance was reported in 98% of cases. Adverse events were revealed in 5.7% of patients, mostly nausea (3.8%). No serious adverse events were reported. CONCLUSION: Furazolidone containing eradication regimens appear to be an effective and safe empirical therapy in Russia.

[Fecal microbiota transplantation: donor selection criteria, storage and preparation of biomaterials (review of current recommendations)].

Fecal microbiota transplantation is a treatment method based on the introduction of donated fecal material to the recipient in order to restore the damaged composition of the intestinal microbiota. This review summarizes existing data on indications for fecal microbiota transplantation, recommendations for donor selection, processing and storage of donor biomaterial.

[European Registry on the management of Helicobacter pylori infection: features of diagnosis and treatment in Kazan].

BACKGROUND: As part of an observational multicenter prospective study European Registry on the management of Helicobacter pylori infection, conducted on the initiative of the European H. pylori and Microbiota Study Group, the compliance of clinical practice in the management of patients with Helicobacter pylori infection in Kazan with clinical guidelines was assessed. MATERIALS AND METHODS: The data of 437 patients included into the register by clinical sites in Kazan in 20132019 were analyzed. The methods used for the initial diagnosis of H. pylori infection and eradication control were evaluated. The frequency of various eradication therapy regimens prescription was analyzed in 379 cases. Data regarding the effectiveness of eradication therapy was analyzed in 173 patients. RESULTS: The rapid urease test (44.2% of cases) and cytology/histology (60% of cases) were most often used for the initial diagnosis of H. pylori infection; however non-invasive methods such as 13C-urea breath (9.2%), serology (6.2%), H. pylori stool antigen test (2.3%) were less common. In 21.7% of patients two methods of H. pylori detection were used for primary diagnosis. The control test to evaluate the effectiveness of eradication therapy at the recommended timepoint was performed in 46.2% of patients. 13C-urea breath test (31.7%), stool PCR/stool antigen test (28.7%), rapid urease test (22.3%), cytology/histology (26.2% of cases) prevailed in the assessment of eradication rate. Standard triple therapy, including proton pump inhibitor, clarithromycin and amoxicillin was most commonly prescribed as first-line therapy (64.6% of cases). The duration of eradication therapy was 14 days in the majority of cases with pantoprazole as the most common proton pump inhibitor in standard triple therapy regimens (84.8%). The efficacy of 14-day standard triple therapy (mITT) was 87.0%. CONCLUSION: The results indicate a high frequency of non-invasive methods use for assessing the effectiveness of eradication therapy; however, the overall rate of eradication efficacy assessment is low, limiting the possibility of analyzing the eradication results. The effectiveness of the most common 14-day standard triple first-line therapy in Kazan doesnt reach the recommended 90% eradication level. This could be explained by high rate of pantoprazole use, which is not an optimal proton pump inhibitor in eradication therapy regimens.

Markers of dysbiosis in patients with ulcerative colitis and Crohn's disease.

AIM: The aim of the study was to study the taxonomic and functional composition of the gut microbiota in ulcerative colitis (UC) and Crohn's disease (CD) patients to identify key markers of dysbiosis in IBD. MATERIALS AND METHODS: Fecal samples obtained from 95 IBD patients (78 UC and 17 CD) as well as 96 healthy volunteers were used for whole-genome sequencing carried out on the SOLiD 5500 W platform. Taxonomic profiling was performed by aligning the reeds, not maped on hg19, on MetaPhlAn2 reference database. Reeds were mapped using the HUNAnN2 algorithm to the ChocoPhlAn database to assess the representation of microbial metabolic pathways. Short-chain fatty acids (SCFA) level were measured in fecal samples by gas-liquid chromatographic analysis. RESULTS: Changes in IBD patients gut microbiota were characterized by an increase in the representation of Proteobacteria and Bacteroidetes phyla bacteria and decrease in the number of Firmicutes phylum bacteria and Euryarchaeota phylum archaea; a decrease in the alpha-diversity index, relative representation of butyrate-producing, hydrogen-utilizing bacteria, and Methanobrevibacter smithii; increase in the relative representation of Ruminococcus gnavus in UC and CD patients and Akkermansia muciniphila in CD patients. Reduction of Butyryl-CoA: acetate CoA transferase gene relative representation in CD patients, decrease of absolute content of SCFA total number as well as particular SCFAs and main SCFAs ratio in IBD patients may indicate inhibition of functional activity and number of anaerobic microflora and/or an change in SCFA utilization by colonocytes. CONCLUSION: the revealed changes can be considered as typical signs of dysbiosis in IBD patients and can be used as potential targets for IBD patients personalized treatment development.

[European registry Helicobacter pylori (Hp-EuReg): how has clinical practice changed in Russia from 2013 to 2018 years].

The multicenter prospective observational study initiated by the European Helicobacter and Microbiota Study Group (EHMSG) is conducted in 27 countries in Europe. The data from the Russian part of the European registry for the management of Helicobacter pylori infection (European Registry on the management of Helicobacter pylori infection, protocol: "Hp-EuReg") allows us to analyze the real clinical practice of diagnosis and treatment of H. pylori and compare it with international recommendations. MATERIALS AND METHODS: A comparative analysis of the data entered in the register by the Russian research centers "Hp-EuReg", in the period from 2013 to 2018, was conducted. RESULTS AND DISCUSSION: Invasive diagnostic methods prevail for the primary diagnosis of H. pylori [histology - 20.3% (in 2013 year) - 43.9% (in 2018 year), rapid urease test - 31.7% and 47.8% respectively]. The most popular mode of eradication therapy is a 10-day triple therapy (62.8-76.2%), the effectiveness of which does not exceed 79% (per protocol). Invasive tests (histology) are the leading method for control the effectiveness of therapy, however, there is a tendency towards a wider use of non-invasive methods (H. pylori stool antigen - from 17% in 2013 to 29.3% in 2018 and urea breath test from 6.9 to 18.3%, respectively). Serological test to control the effectiveness of eradication is still used from 8.2% (2013) to 6.1% (2018). Eradication therapy was not performed in 28% of patients throughout the entire observation period. CONCLUSION: In Russia, despite approved domestic and international recommendations, deviations in clinical practice persist, both during eradication therapy and in monitoring the effectiveness of eradication therapy.

European Registry on the management of Helicobacter pylori infection (Hp-EuReg): analysis of 2360 patients receiving first-line therapy in Russia.

AIM: European Registry on the management of Helicobacter pylori infection («Hp-EuReg¼) - a multicenter prospective observational study initiated by the European Helicobacter and Microbiota Study Group, conducted in 27 European countries in order to evaluate the real clinical practice of diagnosis and treatment of H. pylori and its comparison with international recommendations. MATERIALS AND METHODS: The analysis of 2360 patients entered in the register by the Russian centres of «Hp-EuReg¼ in 2013-2017, who were underwent 1st line eradication therapy. RESULTS: The most common methods of primary diagnosis of H. pylori are histological (37.7%), rapid urease test (29.2%) and serology (29.7%). The duration of eradication therapy in 9.4% of cases was 7 days, in 65.3% - 10 days, and in 25.3% - 14 days. To control the effec- tiveness of treatment, H. pylori antigen in feces (31.3%), urea breath test (23.4%) and histological method (23.3%) were used. In 3.6% cases was used serology by mistake. In 17.3% of patients control was not carried out. The effectiveness of triple therapy with a PPI, amoxicillin, clar- ithromycin (per protocol) was 67.6%, with 7-day course, 81.1% at 10-day and 86.7% at 14-day course. Eradication rate of triple therapy with addition of bismuth (per protocol) reached 90,6% in the group receiving 10-day scheme and 93.6% in the group receiving the 14-day treatment. CONCLUSION: Significant deviations of clinical practice from expert recommendations, most pronounced at the stage of monitoring the effectiveness of therapy, were noted. The suboptimal efficacy of triple therapy is shown.

[European Registry on the management of Helicobacter pylori infection (Hp-EuReg protocol): The first results of Russian centers].

AIM: To assess the clinical practice of diagnosis and treatment in patients with Helicobacter pylori infection and to compare this practice with the international guidelines in the European Registry on the management of Helicobacter pylori infection, Hp-EuReg protocol), a multicenter prospective observational study initiated by the European Helicobacter and Microbiota Study Group. MATERIALs AND METHODS: The data of 813 patients infected with H. pylori and entered in the Hp-EuReg register by the Russian centers in 2013-2015 were analyzed. RESULTS: The most common methods for the primary diagnosis of H. pylori infection are histology (40.3%), rapid urease test (35.7%), and serology (17.2%). The duration of H. pylori eradication therapy was 7, 10, and 14 days in 18.0, 49.3, and 25.1%, respectively. To monitor the effectiveness of treatment, the investigators used a histological examination (34%), a urea breath test (27.3%), H. pylori stool antigen (22.8%), and a rapid urease test (16.3%). A serological test was carried out in 2.5% of the cases. No monitoring was done in 13.5% of the patients. The average eradication efficiency was 82.6%. If the therapy was ineffective, 80% of physicians did not intend to prescribe a new cycle of treatment. CONCLUSION: Significant differences were found between clinical practice and the current guidelines.

ERADICATION THERAPY OF HELICOBACTER PYLORI: PRESENT AND FUTURE.

Recently the rate of successful H. pylod eradication while using existing treatment regimens continues to decline, primarily due to the appearance of antibiotic-resistant strains of the microorganism. Recent studies confirm the fact that the standard triple therapy becomes ineffective method of H. pylori eradication, due to the increase of drug-resistant strains of.H. pylon. H. pylori resistance level to antibacterial agents is not the same in different countries, as well as in certain regions within the same country. Thus, studing the regional features of H. pylori resistance to certain antibiotics with subsequent development of eradication regimens that are effective in particular region becomes extremely actual. Still bismuth containing quadruple therapy remains an effective method of H. pylori eradication, allowing to achieve good results. In recent years, several alternative schemes of H. pylori eradication were proposed, such as sequential, concomitant, hybrid therapy including three antimicrobial agents. Currently; these regimens allow to achieve quite high H. pyloneradication level.

[Clinical case of a combination of ulcerative colitis and alopecia areata].

Extraintestinal manifestations of inflammatory bowel diseases (IBD) are common in both ulcerative colitis and Crohn's disease. Dermatological manifestations have been reported in one-third of all extraintestinal manifestations of IBD. Erythema nodosum and pyoderma gangrenosum are the most frequently described in the literature. There is no data on the development of alopecia as a cutaneous manifestation of IBD in most of studies. A clinical case of combination of ulcerative colitis and alopecia in young woman is presented in the article. There are several possible causes of alopecia in patients with IBD, such as nutritional deficiencies, side effects of medications or autoimmune alopecia. Most often there is no correlation between the severity of clinical bowel manifestations and other organs involvement, and response to therapy. So the combination of alopecia with IBD, in particular ulcerative colitis, confirms the importance of autoimmune mechanisms in genesis of these diseases.

[Results of a multicenter trial "Epidemiology of Gastroesophageal Reflux Disease in Russia" (MEGRE)].

AIM: To assess prevalence of gastroesophageal reflux disease (GERD) in Russia in MEGRE trial in 6 cities of the Russian Federatiion (Kazan, Kemerovo, Krasnoyarsk, Ryazan, St-Petersburg, Saransk). MATERIAL AND METHODS: Mayo Clinic questionnaire (USA) adapted for Russia was used to question 7812 people over 18 years of age from of random population sample. The symptoms (heartburn and regurgitation) were classified as frequent if they arose once a week and more often for the last 12 months, rare symptoms arose less often than once a week. The responders with frequent heartburn and/or regurgitation were regarded as persons with epidemiological quantitative criteria of GERD. RESULTS: Heartburn occurred in 47.5% responders: frequent in 9%, rare in 38.5%. Regurgitation occurred in 42.9%: frequent in 7.6%, rare in 35.3%. GERD prevalence was 13.3% (city range 11.3-14.3%). Frequent GERD symptoms are associated with frequent gaseous eructation (24.3%), chronic cough (22.9%), chest pain (15.1%), dysphonia (11.4%.). To stop heartburn, 88% responders took antacids, 32%--blockers of histamine H2-receptors and only 23%--inhibitors of proton pump. Only 52.8% responders with frequent chest pain and 29.3% those with frequent heartburn visited a doctor. CONCLUSION: The population-based trial MEGRE conducted by international methodology in 6 cities of Russia demonstrated that GERD prevalence is 13.3%. Most of the patients pay little attention to the symptoms, do not seek medical advice and, therefore, receive no adequate treatment.

[Lanzoptol efficacy at gastroesophageal reflux disease: results of multicenter study leader].

Results of multicenter study "Efficacy of Lansoptol (lansoprazole, KRKA) and its influence on the Dynamics of GERD symptoms" (LIEDER) are presented. The impact of 56-days treatment with lansoprazole 30 mg once daily on symptoms relief, a quality of life of 121 patients with gastroesophageal reflux disease (GERD) and healing of esophageal lesions of 30 patients with reflux esophagitis were investigated. Rapid acid inhibition effect of first dose of lansoptol was shown by 48-hr pH-monitoring. At the first day of the treatment 43.1% of patients reported decreasing of intensity of heartburn and 36.5%--of regurgitation. It were shown that the treatment with lansoptol provided symptoms relief in 25% patients at day 3, in 50% of patients at day 5 and in 75% at day 8 for heartburn, and at days 2, 6 and 9--for regurgitation. It was conducted improvement of quality of life. Healing rate of esophagitis at 28 day was 83.3%.

[Restoration of the quality of life by eliminating and prevention of heartburn by alginate: results of multicenter study "VIA APIA"].

Was conducted a muIticenter study VIA APIA, in which the impact of gaviscon forte (suspension) on symptoms, general state and quality of life of 148 patients (male 53, female 95, age 42.9 +/- 15.6) with gastroesophageal reflux disease (GERD) were investigated. The patients had undergone clinical evaluation of dynamics of GERD symptoms (Likert scale), general state (Visual Analogue Scale, questionnaire SAN) and quality of life (SF-36). It was shown that 14-days treatment with gaviscon forte provided symptoms relief in 84.5% patients and conducted improvement of general state and quality of life. Gaviscon forte recommended as drug of choice in initial treatment for the first time visited patient with heartburn before endoscopy and for pathogenetic treatment of typical reflux syndrome.

[Multicentre study "Epidemiology of gastroesophageal reflux disease in Russia"(MEGRE): first results].

We aimed to determine the prevalence and clinical spectrum of GERD in the urban population of 6 cities in different parts of Russia (St. Petersburg, Ryazan, Kazan, Kemerovo, Krasnoyarsk and Saransk). A previously validated reflux questionnaire developed at the Mayo Clinic was translated into Russian, culturally adapted and administered. Data was collected from 7812 randomly selected subjects greater than 18 years old with the assistance of the yellow pages. 'Frequent symptoms' were defined as a major symptom (heartburn and/or regurgitation) occurring at least once a week or more. "Occasional symptoms" were defined as an episode of one of the major symptoms occurring less than once a week within the past 12 months. Patients were defined as having GERD if they reported frequent heartburn and/or regurgitation. The average prevalence of frequent and occasional GERD symptoms in Russia was 9% and 38.5% for heartburn and 7.6% and 35.3% for regurgitation respectively within the last 12 months. The average prevalence of GERD in Russia was 13.3% (11.3-14.3%). The prevalence of frequent heartburn decreased with age (r = -0.3); however, frequent regurgitation increased (r = 0.7) with age. As a result, we found that prevalence of GERD increased with age. The average prevalence of GERD was statistically the same in men (12.5%) and in women (13.9%). This prevalence didn't change with age in men but did increase with age in elderly women to 24%. Frequent heartburn and regurgitation (GERD) were significantly associated with frequent belching (24.3%), chronic cough (22.9%), dyspepsia (19.8%), non-cardiac chest pain (15.1%), nausea (14.9%), hoarseness (11.4%), dysphagia (8.1%), odynophagia (7.3%) and constipation (37.8%). Alcohol consumption (prevalence of 60.4% among respondents) and smoking (prevalence of 25.4% among respondents) didn't yield any significant difference in subjects with frequent symptoms. Importantly, we also found that only 52.8% of subjects with frequent chest pain and 29.3% of respondents with frequent heartburn had seen a physician for these symptoms.

[Peculiarities of genotype distribution of interleukins (IL-1 and IL-10) in patients with peptic ulcer disease and their associations with persistence of Mycoplasma hyorhinis and Helicobacter pylori genotypes].

It was found for the first time in our study that there is a significant prevalence of combinations of IL-1 and IL-10 genotypes--IL-1B-511C/C, IL-1B+3954C/C, IL-1RN1/1, IL-10-1082A/A and IL-1B-511T/C, IL-1B+3954C/C, IL-1RN1/2, IL-10- 1082A/G--in the group of patients with gastric and duodenal ulcer disease and control one, respectively. The correlation between the Tox- (cagA- vacAs1-) strains of H. pylori and the combinations of genotypes IL-1B-511T/C, IL-1B +3954C/C, IL-1RN1/1, IL-10-1082G/G was shown (p <0,05). Co-infection with H. pylori and M. hyorhinis was detected in 19% of patients. The association between combinations of genotypes IL-1B-511T/T IL-1B+3954C/C, IL-1RN2/2, IL-10-1082A/G and co-infection with H. pylori and M. hyorhinis was also found (p <0,05).

[Results of an open multicenter study of the efficiency of one-week anti-helicobacter therapy using omeprazole, clarithromycin, and amoxicillin in patients with duodenal peptic ulcer]. / Rezul'taty otkrytogo mnogotsentrovogo issledovaniia éffektivnosti odnonedel'noi antikhelikobakternoi terapii s primeneniem omeprazola, klaritromitsina i amoksitsillina u bol'nykh iazvennoi bolezn'iu dvenadtsatiperstnoi kishki.

AIM: To study the efficiency of one-week antihelicobacter therapy using omeprazole, clarithromycin, and amoxycillin in patients with duodenal peptic ulcer during its recurrence. MATERIALS AND METHODS: 105 patients with recurrent peptic ulcer and a not less than 0.5-cm ulcer in the duodenal bulb was given triple therapy: omeprazole, 20 mg twice daily, amoxycillin, 1000 mg twice daily, and clarithromycin, 500 mg twice daily for 7 days. Then the patients were allowed to take antacids if they were required to abolish the symptoms of recurrent peptic ulcer. H. pylori was detected in the mucosal biopsy specimens taken from the anthral part and body of the stomach at gastroduodenascopy, by using the rapid urease test and histology. Gastroduodenoscopy was performed before and 4-6 weeks after the triple therapy. RESULTS: The major symptoms of recurrent peptic ulcer were eliminated in 90% of the patients by the end of a course of therapy, i.e. on its day 7. By the control time, the rate of ulcer cicatrization was 99.05% (104/105). The coincidence of results of the two tests has indicated that H. pylori eradication was 81.9% (86/105) 4-6 weeks after termination of treatment. Adverse reactions during therapy were observed in 20% of the patients; however, treatment had to be discontinued only in 2.9% of the patients. CONCLUSION: One-week triple therapy using omeprazole, clarithromycin, and amoxycillin in highly effective in treating duodenal peptic ulcer during its recurrence.

[Clinical efficacy of using ximedon in surgical practice]. / Klinicheskaia éffektivnost' primeneniia ksimedona v khirurgicheskoi praktike.

Results of clinical trial of the new pyrimidine derivative--ximedone are presented. The drug was administered per os 0.5 g x 4 times a day (0.5 h before meals). Total course dose achieved 60 g. Ximedone implementation for complex treatment of burns, trophic ulcer of lower limbs, different inflammations demonstrated positive results. Prophylaxy administration of the drug in abdominal surgery at acute appendix resulted with lower incidence of postoperative complications. High efficacy and good tolerability of the drug allows to recommend it for wide medical use.

[Ximedone in the treatment of patients with burns]. / Primenenie ksimedona v lechenii obozhzhennykh.

The authors studied xymedone, a new medicamentous agent from the group of pyrimidine derivatives. It was prescribed per os, 0.5 g taken three times daily. The experimental group consisted of 52 patients with IIIA and B degree thermal burns covering an area of 10 to 40%. The comparative appraisal was conducted with patients (60) treated by a complex of measures including methyluracil. Analysis of the obtained data showed a statistically significant, as compared to the controls, more rapid restoration of the peripheral blood parameters, decrease of C-reactive protein and level of sialic acid, and increase of total protein content and its gamma globulin fraction. Xymedone contributed to correction of blood dysproteinemia and produced an active effect on nucleic acid metabolism; the level of nucleic acids in the cells of the granulation tissue was much higher in the experimental group after treatment than in the controls. The normal ratio of T- and B-lymphocytes was restored and the phagocytosis indices grew. The production of coagulation and anticoagulation factors became normal, which coincided with cleaning of the granulations from fibrinous deposits and disappearance of the pathological predisposition to bleeding and easy damage of the granulation tissue. Under the effect of the agent the patients' appetite improved, the duration of the dehydration phase reduced, the rate of growth of microgranular granulations and epithelium increased, and the incidence of keloid cicatrices decreased. No unfavorable side effects of the agent were encountered. Xymedone is recommended for wide use in medical practice.

[Membrane permeability in combined arterial hypertension and pathology of the digestive organs (based on epidemiological study data)]. / Sostoianie membrannoi pronitsaemosti pri sochetanii arterial'noi gipertonii s patologiei organov pishchevareniia (po dannym épidemiologicheskogo issledovaniia).

An epidemiological study of arterial hypertension and digestive diseases revealed 27% patients with concurrent abnormalities. It was shown that determination of membranous lesions by the rate of red blood cell Na-Li contratransport may be useful in the diagnosis of syntropy.