| Background:Helicobacter pylori colonizes the stomachs of approximately 50%of the global population,which had a prevalence of 50%in China.Helicobacter pylori is a main pathogen for chronic gastritis,peptic ulcer disease,gastric cancer and gastric mucosa-associated lymphoid tissue lymphoma.Meanwhile,it is associated with many extra-gastric diseases,such as unexplained iron deficiency anemia,metabolic syndrome and immune thrombocytopenic purpura.Helicobacter pylori eradicating reduces the severity of chronic atrophic gastritis and prevent metachronous gastric cancer in patients with early gastric cancer,which may effectively reduce the burden of gastric cancer in China.The eradication failure of Helicobacter pylori has been becoming more and more common worldwide.The main causes of this phenomenon include the increasing antibiotic resistance,poor patient compliance and non-standard regimen.The failure of eradication exacerbates the difficulty of rescue therapies.Difficult-to-treat Helicobacter pylori infection usually refers to patients who fail after 3 or more eradication therapies.Therefore,novel rescue regimen has been urgently required for solving the therapeutic dilemma.Aims:The aim of this pilot study was to evaluate the effectiveness and tolerability of the modified sequential regimen in patients with difficult-to-treat Helicobacter pylori infection.The characteristics of antibiotic resistance of Helicrobacter pylori were analyzed.Methods:A total of 60 patients proven Helicobacter pylori infection by’3C-urea breath test(13C-UBT),rapid urease test or histological examination were involved in this study from October 2018 to December 2019 in Qilu Hospital of Shandong University.Patients with persistent Helicobacter pylori infection after at least 3 failed standard quadruple eradication therapies were eligible for enrollment.Patients were scheduled to undergo blood routine examination,hepatic and renal function test,esophagogastroduodenoscopy and Helicobacter pylori culture before enrolled in this research.Patients were treated with modified sequential therapy containing esomeprazole 40 mg/rabeprazole 20 mg,amoxicillin 1 g,furazolidone 100mg and tetracycline 500mg for the first 7 days,followed by esomeprazole 40 mg/rabeprazole 20 mg,amoxicillin 1 g,tetracycline 500mg and colloidal bismuth pectin 220mg for another 7 days(PPI and amoxicillin were given twice daily,tetracycline was given four times per day,furazolidone was given three times per day).Helicobacter pylori eradication was defined as a negative result in 13C-UBT performed at least 8 weeks after the end of treatment.All subjects were asked to stop histamine 2 blocker and proton pump inhibitor for at least four weeks before 13C-UBT.Compliance was assessed by standardized interview at the end of treatment,as well as by pill count in the medication boxes returned at the interview.Compliance was considered low when<90%of pills were taken.The patients were asked to record the adverse events throughout the trial.A standardized interview and case report form were used to assess the adverse events and compliance at the end of treatment.Results:A total of 60 patients participated in this study,and 56 patients completed the whole study.The eradication rate in the intention-to-treat analysis,modified intention-to-treat analysis and per-protocol analysis were 83.3%,93.0%and 94.6%,respectively.42.4%of enrolled patients had adverse events and all of them were mild to moderate.Only 3.4%of patients discontinued medication due to the intolerance of adverse effect.Patients with good compliance accounted for 94.9%.Among 50 culture positive specimens,the resistance rate of clarithromycin,metronidazole,levofloxacin and amoxicillin were 60.0%,100.0%,70.0%and 2.0%.Helicobacter pylori existence of multiple drug resistance to metronidazole,levofloxacin and clarithromycin-resistant strains was 54.0%。Conclusion:Modified sequential therapy could achieve good eradication rate(>90%)for difficult-to-treat Helicobacter pylori infection with safety and good compliance. |
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