[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.

[Efficacy of H. pylori eradication depending on genetic polymorphism of CYP2C19, MDR1 and IL-1ß].

AIM: To evaluate an association of genetic polymorphisms CYP2C19, MDR1, and IL-1ß on the eradication rate by 10-day modified therapy in patients with H. pylori - associated diseases. MATERIALS AND METHODS: In this study was conducted a prospective, randomized trial, included 89 patients with H. pylori - associated diseases. They were divided into 2 groups depending on therapy: clarithromycin 500 mg, b.i.d., amoxicillin 1000 mg, b.i.d., bismuth subcitrate 240 mg, b.i.d. rabeprazole 20 mg or 40 mg, b.i.d. for 10 days. All subjects underwent pharmacogenetic testing of CYP2C19, MDR1, and IL-1ß. RESULTS AND DISCUSSION: Per - protocol (PP) eradication rates in group with rabeprazole 40 mg were 97.6% (41/42; 95% CI 87.7-99.6), in group with rabeprazole 20 mg were 82.1% (32/39; 95% CI 67.3-91.0). Intention - to - treat analysis in group with rabeprazole 40 mg eradication rates were 89.1% (41/46; 95% CI 77.0-95.3), in group with standard dose rabeprazole - 74.4% (32/43; 95% CI 59.8-85.1). No significant differences in eradication rates between the groups of ultrarapid, rapid, normal and intermediate CYP2C19 metabolizers (PP: 93.5%/90.3%/84.6% respectively; χ2=0.87, p=0.65). Eradication rates in group with IL-1ß CC genotype there was no difference among the IL-1ß CT and TT genotype groups (PP: 92.9%/85.7%/94.7% respectively; χ2=1.34; p=0.51). The cure rate among MDR1 TT genotype was significantly lower than among subjects in the MDR1 CC/CT genotype groups (PP: 76.2% vs 96.3%: χ2=5.04; p=0.025; OR=8.13). CONCLUSION: Ten - day modified triple therapy with high dose rabeprazole significantly high eradication rates in patients with H. pylori - associated diseases. Independent factor for treatment failure is MDR1 CC/CT genotype status.

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.

[COMPARATIVE STUDY OF DE-NOL AND NOVOBISMOL IN REGIMENS ERADICATION IN PATIENTS WITH H. PYLORI--ASSOCIATED DISEASES].

AIMS: The aim of this study is to assess efficacy and safety of reinforced H. pylori eradication therapy. METHODS: During 2013-2014, 40 outpatients were examined. The study included men and women 18-65 y.o. They have been devided in to 2 group by randomized choice (20 patients in each group). Patients were treated with the reinforced H. pylori eradication therapy: PPI (40 mg,/q12h), clarithromycin (500mg/q12h), amoxicillin (1000 mg/q12h), bismuth subcitrate (240 mg/q12h) for 10 days. The first group given bismuth subcitrate--De-Nol, the second group given Novobismol. Eradication was confirmed by a 13C-urea breath test and monoclonal stool antigen test 6-8 weeks after therapy. RESULTS: A total of 34 patients underwent eradication treatment. Two were lost to follow-up (one patient in each group), four patients (two patients in each group) did not complete treatment due to adverse events. The eradication rates were 97.1% (95% CI, 88.9% -100.0%) by per-protocol (PP) and 82.5% (95% CI, 69.4% - 92.5%) by intention-to-treat (ITT) in the two groups. The ITT analyses resulted in rates of 85% (95% CI, 66.5-96.9) for the 10-d reinforced therapy with DeNol and was 80% (95% CI: 60.2-94.1) for the 10-d reinforced therapy with Novobismol (P = 0.68), while the PP analyses resulted in 100% (95% CI, 94.5-100.0) and 94.1% (95% CI: 78.3-99.9), respectively (P = 0.31). CONCLUSION: The reinforced H. pylori eradication therapy (10-day high-dose PPI bismuth-containing standard triple therapy) achieves a significantly high eradication rates in patients with H. pylori - associated diseases. Both drugs (De- Nol and Novobismol) are both effective and safe for the first-line eradication of H. pylori.