Eradication Treatment Of Helicobacter Pylori Infection In Penicillin-Allergic Populations:A Prospective Study

Background:The prevalence of Helicobacterpylori(H.pylori)infection is 50%in China.Eradication of H.pylori delays the progression of atrophic gastritis,promotes the healing of peptic ulcers and reduces recurrence,and reduces the incidence of gastric cancer.Currently,the both national and international guidelines recommend eradication therapy for patients with H.pylori infection.The consensus in China recommends a bismuth quadruple regimen(acid suppressant+bismuth+two antibiotics)for the initial and rescue treatment of people with H.pylori infection.In recent years,the eradication rate of H.pylori has gradually decreased as the rate of antibiotic resistance has increased.Amoxicillin has a low resistance rate and few adverse effects and is the core drug for eradicating H.pylori.However,about 10%of the population is allergic to penicillin and cannot take amoxicillin,making H.pylori eradication more challenging in the penicillin-allergic population.Providing safe and effective treatment options for this special population has significant clinical value.Aims:This study is planned to investigate the therapy of H.pylori infection in penicillin-allergic populations,with the following main Aims:1.To evaluate the effectiveness of two bismuth quadruple regimens containing vonoprazan and tetracycline in the initial treatment of H.pylori infection in a penicillin-allergic population.2.To assess the efficacy,safety and compliance of a 14-day bismuth quadruple regimen containing vonoprazan,tetracycline and furazolidone in the rescue treatment of H.pylori infection in penicillin-allergic populations.Materials and Methods:Part 1:Patients with initial H.pylori infection and penicillin allergy were prospectively enrolled in this study and randomized to the 14-day PBTL regimen(vonoprazan 20 mg bid,bismuth potassium citrate 220 mg bid,tetracycline 500 mg qid,levofloxacin 500 mg qd)and PBTM regimen(vonoprazan 20 mg bid,bismuth potassium citrate 220 mg bid,tetracycline 500 mg qid,metronidazole 400 mg qid)groups.To assess H.pylori eradication rates,safety and compliance to different treatment regimens.Part 2:This study prospectively enrolled patients who required rescue treatment for H.pylori infection and were allergic to penicillin.All patients were treated with a 14-day PBTF regimen(vonoprazan 20 mg bid,bismuth citrate potassium 220 mg bid,tetracycline 500 mg qid,furazolidone 100 mg bid).To evaluate the eradication rate,safety and compliance of the PBTF regimen.Results:Part 1:A total of 62 patients were enrolled in this study(31 in the PBTL group and 31 in the PBTM group).In the intention to treat analysis(ITT analysis),the H.pylori eradication rate in both groups was 87.1%(27/31)(P>0.999).And in the per protocol analysis(PP analysis),the H.pylori eradication rates were 93.1%(27/29)and 90.0%(27/30)in the PBTL and PBTM groups,respectively(P>0.999).There was no statistical difference in the eradication rate between the two groups in both ITT analysis and PP analysis.There was no statistical difference in the incidence of adverse effects and compliance between the PBTL and PBTM groups.Part 2:This study prospectively enrolled 136 patients treated with a 14-day PBTF regimen,and in the ITT analysis,modified ITT analysis(MITT analysis),and PP analysis,the H.pylori eradication rates were 89.7%(122/136),96.1%(122/127),and 96.8%(121/125),respectively.The overall incidence of adverse reactions was 28.7%(39/136),all of which were mild to moderate,and no serious adverse reactions occurred.The percentage of patients with≥80%compliance was 96.3%(131/136).Conclusions:1.In the initial treatment of H.pylori infection in penicillin-allergic populations,the preliminary results of the study indicate that the 14-day PBTL regimen and PBTM regimen had high eradication rates,and both demonstrated good safety and patient compliance.2.The 14-day PBTF regimen has a good H.pylori eradication rate,with a low incidence of adverse effects and good patient compliance.This regimen can be used as an option for the rescue treatment of H.pylori infection in penicillin-allergic populations.