Efficacy Of PPI/P-CAB Based Dual High-dose Therapy In Helicobacter Pylori Treatment

Background&aims:With the increasing rate of antibiotic resistance,the eradication rate of Helicobacter pylori has decreased in recent years.In this context,we explore PPI/P-CAB-based dual high-dose therapy for Helicobacter pylori infection and provide more treatment options for clinical Helicobacter pylori eradication therapy.Methods:1.Efficacy observation study of PPI（esomeprazole）-based dual high-dose therapy 439 patients with Hp infection enrolled from January2020 to December 2021 were randomly divided into dual high-dose group（experimental group:esomeprazole enteric-coated tablets 20 mg Qid+amoxicillin capsules 750 mg Qid）and quadruple group（control group:esomeprazole enteric-coated tablets 20 mg Bid+amoxicillin capsules 1g Bid+clarithromycin sustained-release tablets 0.5g Bid+colloidal bismuth tartrate capsules 165 mg Qid）.One month after the end of treatment,¹³C/¹⁴C-urea breath test was reexamined to observe the eradication rate,adverse drug reactions and symptom relief in the two groups.2.P-CAB（vonoprazan）-based dual high-dose therapy efficacy observation study 127 patients with Hp infection enrolled from July 2021to January 2022 were randomly assigned to the dual high-dose group of vonoprazan（experimental group:vonoprazan tablets 20 mg Bid+amoxicillin capsules 1000 mg Tid）and the triple group of vonoprazan（control group:vonoprazan tablets 20 mg Bid+amoxicillin capsules1000 mg Bid+clarithromycin sustained-release tablets 500 mg Bid）.One month after the end of treatment,13C/14C-urea breath test was reexamined to observe the eradication rate,adverse drug reactions and symptom relief in the two groups.Results:1.The eradication rates of esomeprazole dual high-dose therapy and quadruple therapy were 70.59%and 83.49%（ITT）,92.86%and 98.38%（PP）,respectively,and the difference was statistically significant（P<0.05）.The adverse reaction rates of the two groups were 4.98%and8.72%,respectively,and the difference was not statistically significant（P>0.05）,and the adverse reactions were mainly manifested as rash,bitter taste,diarrhea,nausea,and loss of appetite.The symptom remission rates of the two regimens were 94.30%and 96.51%,respectively,and the difference was not statistically significant（P>0.05）,and the main symptoms were abdominal pain,halitosis,abdominal distension,acid reflux,and belching,and the symptoms of weight loss,melena,and hematemesis were rare.Hp eradication rate was found to be independent of gender and age by univariate analysis（P>0.05）.The follow-up rate was 80.41%.2.The eradication rates of vonoprazan dual high-dose therapy and vonoprazan triple therapy were 83.87%and 78.46%（ITT）,98.11%and94.44%（PP）,respectively,and the difference was not statistically significant（p>0.05）.The adverse reaction rates of the two groups were11.29%and 12.31%,respectively,and the difference was not statistically significant（P>0.05）,and the adverse reactions included diarrhea,nausea,bitter taste,epigastric discomfort,aggravated abdominal pain,abdominal distension,rash,vomiting,and molting of both hands.The symptom relief rates of the two regimens were 92.68%and 95.74%,respectively,and the difference was not statistically significant（P>0.05）,and halitosis,abdominal distension,acid reflux,and abdominal pain were more common in discomfort symptoms,while nausea,belching,hiccup,vomiting,and melena were less common.Hp eradication rate was found to be independent of gender and age by univariate analysis（P>0.05）.Follow-up was 84.25%.Conclusion:1.Esomeprazole-based dual high-dose Hp eradication regimen has better Hp eradication efficacy,but the traditional quadruple therapy eradication rate is better,the adverse reactions of the two groups are lower,and there is a good symptom relief effect.2.There was no significant difference in the eradication rate and adverse reaction rate between the dual high-dose regimen and the triple regimen based on vonoprazan.According to the per-protocol analysis,the eradication rate reached more than 90%,the satisfactory eradication efficacy was achieved,and the better symptom relief effect and the lower adverse reaction rate were obtained.