| Objectives To observe and compare the efficacy, symptom remission,adverse reactions and cost-effectiveness analysis of four bismuth-based quadruple therapy to eradicate Helicobacter pylori and to investigate the correlation between Helicobacter pylori eradication rate and delta over baseline values of 13C-urea breath test. Subjects and MethodsSubjects: Patients who came to Gastroenterology Clinic of The Second Hospital of Tianjin Medical University for their upper gastrointestinal symptoms from April 2013 to December 2014;all of them underwent electronic gastrocope and were diagnosed as Helicobacter pylori infection by 13C-urea breath test.Methods: According to different Helicobacter pylori treatment,441 patients who were chosen for the study were divided into two groups: rabeprazole group(Group A) and pantoprazole group(Group B).Group A was divided into two groups: levofloxacin group(Group A1) and tinidazole group(Group A2),126 patients in Group A1 received rabeprazole 20 mg twice daily + compound bismuth aluminate granules 2600 mg twice daily + clarithromycin 500 mg twice daily + levofloxacin 500 mg once daily;108 cases in Group A2 were treated with rabeprazole 20 mg twice daily + compound bismuth aluminate granules 2600 mg twice daily + clarithromycin 500 mg twice daily + tinidazole 500 mg twice daily;In the same way, Group B was divided into two groups: levofloxacin group(Group B1) and tinidazole group(Group B2),102 patients in Group B1 received the treatment with pantoprazole 40 mg twice daily + compound bismuth aluminate granules 2600 mg twice daily + clarithromycin 500 mg twice daily + levofloxacin 500 mg once daily;105 cases in Group B2 were treated with pantoprazole 40 mg twice daily + compound bismuth aluminate granules 2600 mg twice daily + clarithromycin 500 mg twice daily + tinidazole 500 mg twice daily. All groups received different treatments for 10 days. Followed up and recorded the status of patients’ general condition, upper gastrointestinal symptoms,results of gastrocope, delta over baseline values of 13C-urea breath test,medication compliance and drug adverse reactions. At least 4 weeks after the end of the treatment,13C-urea breath test were performed again to evaluate efficacy of Helicobacter pylori eradication. Compare the Helicobacter pylori eradication rate according to ITT analysis and PP analysis,compare symptom remission and drug side effects of four groups and made the cost-effectiveness analysis of each group and analyze the correlation between Helicobacter pylori eradication rate and DOB values of 13C-urea breath test.Results(1) According to ITT analysis,the eradication rates of Group A1,A2,B1 and B2 were 79.4%,51.9%,82.4% and 57.1% respectively,and according to PP analysis which were 83.3%,56.0%,85.7% and 58.8% respectively.Both ITT analysis and PP analysis showed that eradication rate of Hp for Group A1 was significantly higher than Group A2 and Group B1 had a significantly higher eradication rate of Hp than Group B2(P<0.05); While compared Group A1 with Group B1 and Group A2 with Group B2 respectively,they both had similar Hp eradication rates(P>0.05).(2)The Hp eradication rates of gastric ulcer patients, duodenal ulcer patients and chronic gastritis patients in Group A1 were 90.9%,90.0% and 78.3% respectively;The Hp eradication rates of gastric ulcer patients, duodenal ulcer patients and chronic gastritis patients in Group A2 were 50.0%,58.8% and 55.2% respectively; The Hp eradication rates of gastric ulcer patients, duodenal ulcer patients and chronic gastritis patients in Group B1 were 88.9%,85.3% and 85.5% respectively;The Hp eradication rates of gastric ulcer patients, duodenal ulcer patients and chronic gastritis patients in Group B2 were 45.5%,62.9% and 58.9% respectively.By statistical analysis,the Hp eradication rates of gastric ulcer,duodenal ulcer and chronic gastritis in each group had no significant difference respectively(P>0.05),which means that the Hp eradication rates of gastric ulcer,duodenal ulcer and chronic gastritis in each group were similar. When compared the Hp eradication rates of the three diseases of Group A1 with Group A2 respectively,there were significant difference(P<0.05).The result was the same when compared that of Group B1 with Group B2(P<0.05).That is to say the Hp eradication rates of the three diseases for Group A1 was significantly higher than Group A2 respectively and Group B1 had significantly higher Hp eradication rates of the three diseases than Group B2 respectively.When compared the Hp eradication rates of the three diseases of Group A1 with Group B1 and that of Group A2 with Group B2 respectively,there were no significant difference(P>0.05),which means they both had similar Hp eradication rates of the three diseases.(3)The gastrointestinal symptom remission rates in Group A1,A2,B1 and B2 were 88.3%,80.0%,89.8% and 79.4%.There were no significant difference among the gastrointestinal symptom remission rates of four groups by statistical analysis(P>0.05).(4)The adverse reactions of the four groups are mainly epigastric discomfort, nausea,bitter mouth,anorexia,dizziness and erythra and so on. The rates of adverse reactions in four groups was 10.8%,12.0%,9.2% and 14.7%. There was no significant difference(P>0.05).(5)The cost-effectiveness analysis:Costs of Group A1,A2,B1 and B2 were RMB 434.2,RMB 408.2,RMB 505.4 and RMB 479.4.The cost-effectiveness ratio of Group A1 was minimal,while that of Group B2 was maximal.Regard Group A2 as the control group,the incremental cost-effectiveness ratio of Group A1,B1 and B2 was 0.95,3.27 and 25.43.(6)Analysis of the correlation between Helicobacter pylori eradication rate and DOB values of 13C-urea breath test:Subgrouping patients of four groups into low(DOB<16),intermediate(DOB:16-35) and high(DOB >35) respectively. Helicobacter pylori eradication rates of three subgroups in Group A1 were 86.0%,80.9% and 82.6%,which in Group A2 were 58.5%,55.0% and 52.6%,and that in Group B1 were 87.5%,84.2% and 85.0% while that in Group B2 were 61.5%,56.5% and 58.8%. There were no significant correlation between Helicobacter pylori eradication rate and DOB value by statistical analysis(P> 0.05).Conclusion(1)Levofloxacin-based quadruple therapy demonstrated a higher Hp eradication rate than tinidazole-based regimen while rabeprazole-based quadruple therapy showed a similar Hp eradication rate with pantoprazole-based regimen.(2)The Hp eradication rates of gastric ulcer,duodenal ulcer and chronic gastritis in each group were similar.The Hp eradication rates of gastric ulcer, duodenal ulcer and chronic gastritis for Group A1 were significantly higher than Group A2 respectively and Group B1 had significantly higher Hp eradication rates of the three diseases than Group B2 respectively.Compared Group A1 and Group B1,Group A2 and Group B2, they both had similar Hp eradication rates of gastric ulcer, duodenal ulcer and chronic gastritis respectively.(3)The gastrointestinal symptom remission rates in four groups were similar.(4)The rates of adverse reactions in four groups were no significant difference.(5)Compared with the other three treatments,the quadruple therapy contained both levofloxacin and rabeprazole had higher Hp eradication rate and lower cost, similar gastrointestinal symptom remission rate and adverse reactions rate,better compliance.So it’s an effective, cheap and secure quadruple therapy for Hp infection, which was worth clinical promotion.(6)There were no significant correlation between Helicobacter pylori eradication rate and DOB values,which means that DOB values didn’t significantly affect Helicobacter pylori eradication rate. |
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