The efficiency and safety of anti-Helicobacter pylori therapy in patients with concomitant chronic hepatitis C

Savilova

et al. 2019

Aim. To evaluate an association of genetic polymorphisms CYP2C19, MDR1, and IL-1β 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-1β. 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-1β CC genotype there was no difference among the IL-1β 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.

Section: Discussionunclassified

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

Бакулина

Savilova

et al. 2019

“…В настоящем исследовании нам также удалось выявить тренд к высокому риску наличия резистентности у лиц с предшествующим по данным лекарственного анамнеза приемом макролидов и фторхинолонов, однако он оказался статистически незначим из-за ограниченной выборки пациентов. Вместе с тем в нескольких клинических работах отмечено, что использование макролидов в анамнезе является фактором риска неэффективности ЭТ [18][19][20]. Учитывая эти факты, Американская коллегия гастроэнтерологов (ACG) не рекомендует использование тройной схемы с кларитромицином у лиц, ранее принимавших макролидные антибактериальные препараты [5] применять меры, способствующие повышению ее эффективности [3].…”

Section: îáñóAeäåíèåunclassified

“…Учитывая эти факты, Американская коллегия гастроэнтерологов (ACG) не рекомендует использование тройной схемы с кларитромицином у лиц, ранее принимавших макролидные антибактериальные препараты [5] применять меры, способствующие повышению ее эффективности [3]. Действительно, недавние исследования демонстрируют субоптимальную эффективность 10-дневных курсов данного протокола в нашей стране [19,21,22]. Данный факт актуализирует пролонгацию лечения до 14 дней, а также оптимизацию этой схемы путем добавления четвертым компонентом препарата висмута или ребамипида, эффективность которых в этом аспекте продемонстрирована в недавних метаанализах [23][24][25].…”

Section: îáñóAeäåíèåunclassified

Antibiotic resistance of Helicobacter pylori in the European part of the Russian Federation: first results

Andreev

Govorun

et al. 2020

Self Cite

Aim. Determine the primary antibiotic resistance of Helicobacter pylori (H. pylori) strains isolated from patients living in the European part of the Russian Federation. Materials and methods. As part of a clinical laboratory study, from 2015 to 2018, 27 gastrobiopsy samples obtained from H. pylori-infected patients were analyzed. H. pylori infection was verified using a rapid urease test or a 13C-urea breath test. The values of the minimum inhibitory concentration (MIC) of antibiotics were determined by the diffusion method using E-test strips (BioMerieux, France) according to the recommendations of the manufacturer. The sensitivity of the isolates was determined for 6 antibacterial drugs (amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, rifampicin). Results. According to the data obtained, resistance to amoxicillin was 0%, clarithromycin 11.1%, metronidazole 59.3%, levofloxacin 3.7%, tetracycline 0%, and rifampicin 14.8%. Dual resistance to clarithromycin and metronidazole was recorded in two isolates (7.4%). Conclusion. Thus, the first results of the evaluation of H. pylori antibiotic resistance in the European part of the Russian Federation indicate a low resistance of the microorganism to clarithromycin and quite high to metronidazole.

“…Так, согласно последним метаанализам, эффективность тройной схемы ЭТ находится на уровне около 69-77%, а квадротерапии с препаратами висмута -на уровне 77,6-78,3% [17][18][19][20]. Анализируя последние отечественные работы в этом направлении, можно сделать вывод, что в России наблюдается аналогичная ситуация [21][22][23][24][25]. Учитывая данный негативный тренд, отмечающийся во всем мире, в современных европейских и североамериканских консенсусах предложено использовать альтернативную схему первой линии -квадротерапию без препаратов висмута [ингибиторы протонной помпы (ИПП) + амоксициллин + кларитромицин + метронидазол] в тех регионах, где отмечается низкий уровень эрадикации с использованием классической тройной терапии [12][13][14].…”

Section: Introductionunclassified

The efficacy and safety of quadruple therapy without bismuth (concomitant therapy) in the treatment of patients with Helicobacter pylori - associated gastric and duodenal peptic ulcer disease

Велиев

Andreev

et al. 2019

Aim. Evaluation of the efficacy and safety of quadrupletherapy without bismuth (concomitant therapy) in patients with Helicobacter pylori - associated gastric ulcer and duodenal ulcer in the framework of a comparative research in the population of patients in Russia. Materials and methods. A prospective randomized trial was conducted, which included 210 patients with H. pylori - associated gastric/duodenal ulcer without complications. During the process of randomization, the patients were divided into three equal groups (n=70) depending on the prescribed 10-day scheme of eradication therapy (ET): the first group received the classic triple scheme (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day and Clarithromycin 500 mg 2 times a day); the second group received quadruple therapy with bismuth drugs (Omeprazole 20 mg 2 times a day, Tetracycline 500 mg 4 times a day, Metronidazole 500 mg 3 times a day, Bismuth subcitrate potassium 120 mg 4 times a day); the third group received quadruple therapy without bismuth - concomitant therapy (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day, Clarithromycin 500 mg 2 times a day and Metronidazole 500 mg 2 times a day). Diagnostics of H. pylori infection during screening and control of eradication was carried out via the fast urease biopsy sample test and urea breath test system. Control of the effectiveness of ET of the microorganism was carried out not earlier than 4 weeks after the end of the treatment. During the course of therapy, the frequency of development of side effects was assessed using a special questionnaire. Results and discussion. The effectiveness of triple therapy was 72.8% (ITT; 95% CI of 62.17-83.54) and 78,4% (PP; 95% CI 68.19-88.72); quadruple therapy with the preparation of bismuth - 80.0% (ITT; 95% CI 70.39-89.6) and 84,8% (PP; 95% CI, 75.96-93.73); quadruple therapy without bismuth - concomitant therapy - 84.2% (ITT; 95% CI 75.54-93.02) and 92.1% (PP; 95% CI 85.43-98.94). Quadruple therapy without bismuth was reliably more effective than the classical triple therapy in the PP selection (p=0.044883). Statistical analysis showed a tendency to poorer effectiveness of ET in patients who had previously used antibiotic therapy (OR 0.4317; 95% CI 0.1776-1.049), and in individuals with a rapid metabolism genotype - CYP2C19*1/*1 (OR 0.12; 95% CI 0.005848-2.4624). The frequency of development of side effects during the use of triple therapy was 18.5% (95% CI of 9.23-27.91), when using quadruple therapy with bismuth - 20.0% (95% CI 10.39-29.6), and with the use of quadruple therapy without bismuth - concomitant therapy - 24.2% (95% CI 13.98-34.58). Conclusion. This prospective randomized study demonstrated the high efficiency of quadruple therapy without bismuth (concomitant therapy) in the framework of eradication of H. pylori infection in Russia.