| Objective:Helicobacter pylori(H.pylori)is the most common source of infection in the world.It is the main cause of chronic gastritis and the main cause of gastric cancer and peptic ulcer.Related evidence suggests that eradication of H.pylori can reduce the risk of these diseases.Currently,the internationally recommended H.pylori eradication scheme is the bismuth agent quadruple regimen.However,with the increasing resistance of H.pylori and the potential risks of bismuth application,a safer and more effective eradication treatment plan is needed to deal with the problems of H.pylori resistance,relapse,and treatment side effects.As a new gastric mucosa protector,sofalcone has the dual functions of mucosal protection,bactericidal and anti-inflammatory,and its safety has been well confirmed.In this paper,sofalcone is used instead of bismuth in quadruple therapy for the treatment of H.pylori infection-related gastritis.Evaluate the efficacy of sofalcone quadruple therapy by observing clinical efficacy and safety.The purpose is to provide a possible basis for the use of sofone for H.pylori eradication.Methods:A total of 300 patients with chronic gastritis with H.pylori infection diagnosed in the Department of Gastroenterology of Baoding First Central Hospital since October 2018 were continuously collected.Randomly divided into two groups: group A(150 cases,application: colloidal pectin bismuth 300 mg + clarithromycin 500 mg + rabeprazole 20 mg + amoxicillin 1000 mg twice daily for 14 days)and group B(150 cases,Application: 100 mg of sofalcone + 500 mg of clarithromycin + 20 mg of rabeprazole + 1000 mg of amoxicillin,2 times a day for 14 days of treatment).After treatment,13C-urea breath test,gastroscopy,and clinical symptom index scores were used to compare H.pylori eradication rate,gastroscopy mucosal manifestations,clinical symptoms improvement,and incidence of adverse reactions in the two groups.The eradication rates of the two schemes were compared by ITT analysis and PP analysis,and the results were expressed as percentages and 95% confidence intervals(95% CI).The total effective rate(total effective rate = healing + significant effect + effectiveness)was calculated based on the improvement of mucosa under gastroscopy according to the standards of healing,marked effect,effective,and ineffectiveness.The indigestion symptom rating scale was used to calculate the symptom index(degree × frequency)of the patients’ symptoms before and after treatment,and the common indigestion symptoms of H.pylori infection-related gastritis(Epigastric pain,Upper abdominal fullness,Heartburn,Upper abdominal discomfort,Acid regurgitation)perform a separate calculation for each symptom.The statistical analysis of the improvement of patients’ symptoms was to exclude the cases with no obvious symptoms before treatment,and then calculate the difference between the grades with reduced scores before and after treatment.Safety analysis was expressed as the incidence of adverse reactions after treatment.Results:1.Eradication rate was similarwith both therapies at the ITT analyses: group B 94.7%,95% CI: 91.12-98.28 vs group A 92.7%,95% CI: 88.54-96.86(P>0.05)and PP analyses: group B 97.3%,95% CI:94.61-99.99 vs group A 96.5%,95%CI:93.50-99.50(P>0.05).2.The total effective rate of endoscopic gastric mucosa improvement in the two groups was(group B 94.7% vs group A 80.0%;P<0.05).The improvement of gastric mucosa in the sofalcone group was significantly better than that in the pectin bismuth group.3.After treatment,symptom score reducing index of the total gastrointestinal symptoms and individual symptom(Epigastric pain,Upper abdominal fullness,Heartburn,Upper abdominal discomfort,Acid regurgitation)of group B were higher than those of group A(P < 0.05).4.The total rates of adverse reactions in group B was Significantly lower than that in group A,(group B 5.33% vs group A 12.67%;P < 0.05).Conclusion:Sofalcone replaces bismuth for the treatment of H.pylori infectionrelated gastritis.It can achieve an H.pylori eradication rate comparable to bismuth quadruple therapy,and is superior to bismuth quadruple therapy in clinical symptoms and gastroscopy improvement.Less response and high safety,it can be recommended for the treatment of H.pylori infection-related gastritis. |