Evaluation Of First-line Bismuth-containing 7-day Concomitant Quintuple Therapy For Helicobacter Pylori Eradication

ObjectiveHelicobacter pylori infection is difficult to cure,mainly due to antibiotic resistance.Explore new solutions and dealing with drug resistance is urgent.Our team's previous study showed that the eradication rate of 10-day concomitant therapy was ideal.In addition,the addition of bismuth appeared to increase the eradication rate by an additional 30-40%.Therefore,based on 10-day concomitant therapy,increased bismuth and shortened duration of treatment,we performed a single-center,prospective trial to determine the efficacy and safety of bismuth-containing 7-day concomitant quintuple regimen.Method1.Subjects: This prospective trial was performed from August 1,2015 to February 28,2016 at the first affiliated hospital of Nanchang University,untreated Helicobacter pylori positive patients who were confirmed to be positive by pathology or urea breath test were included.2.Method: A total of 70 patients with Helicobacter pylori infection received 7-day quintuple therapy consisting of bismuth subcitrate 220 mg,esomeprazole 20 mg,clarithromycin 500 mg,amoxicillin 1000 mg,and metronidazole 400 mg,each twice daily.All patients were treated for 7 days.3.The method to assess the status of Helicobacter pylori infection: All patients undergo 13 C urea breath test 4 weeks after the treatment.If the result is negative,it means the eradication treatment was successful.4.If any discomfort occured during the period of the treatment,patients would contact the doctor.All patients were followed up seventh days after the start of eradication treatment,the number of remaining tablets,and adverse effect was recorded.Results70 patients(36 males,34 females,mean age 43.5±11.5 years)were included in this trial,including one person who violated the protocol.The overall eradication rates of the bismuth-containing 7-day concomitant quintuple therapy were 75.4%(ITT analysis)and 86.7%(PP analysis).The treatment compliance rate was 99.6%.The prevalence of side effects was 31.9%,including bitter taste(23.2%),nausea(4.3%),dizziness(2.9%),diarrhea(2.9%),limb asthenia(2.9%),skin rash(1.4%),numbness of the tip of the tongue(1.4%),and insomnia(1.4%).The majority of the adverse effects were mild to moderate and were gradually improved after the cessation of the regimens,but 1 case exited the clinical trial because of intolerable nausea.ConclusionBismuth-containing 7-day concomitant quintuple therapy may not be a superior regimen,Whether it could achieve satisfactory eradication rate by adjusting the combination of antibiotics and drug dose is still worthy of further prospective clinical trial to verify.