Clinical Observation Of Xiao Jianzhong Capsule Combined With Standard Triple Therapy In Eradicating Helicobacter Pylori Infection

Objectives To observe the efficacy of Xiaojianzhong Capsule combined with standard triple therapy in eradicating Helicobacter pylori（H.pylori）,and to explore the advantages in integrated traditional and western medicine of H.pylori.and to provide a new idea for clinical eradication of H.pylori.Methods In this experiment,120 patients who were diagnosed as H.pylori infection by¹⁴C-urea breath test(¹⁴C-UBT)in the Department of Gastroenterology,North China University of Science and Technology Affiliated Hospital were selected.They were divided into treatment group and control group,randomly.The patients in the treatment group were given triple therapy（ie rabeprazole 20mg,amoxicillin 1g,furazolidone 0.1g twice a day）and Xiaojianzhong capsules（1.2g three times a day）.The patients in the control group were given the above triple therapy and potassium bismuth citrate（220mg twice a day）,and the treatment period in both groups was 14 days.All of patients need to review the ¹⁴C-UBT after 4 weeks of withdrawal.The basic informations,the clinical symptom scores and the Disintegrations per minute（DPM）values of the patients were recorded when they saw a docter for the first time.Then recorded the clinical symptom scores,the ¹⁴C-UBT test results and the adverse drug reactions of all patients after 4 weeks of withdrawal.According to the results of ¹⁴C-UBT after 4 weeks of withdrawal to determine whether the H.pylori was eradicated or not.The symptom improvement of the two groups was compared by the clinical symptom scores before treatment and after 4 weeks of drug withdrawal.The symptom improvement of the two groups was compared by the clinical symptom scores of the patients before treatment and after 4 weeks of drug withdrawal.The adverse drug reactions were observed after H.pylori eradication treatment.Then analyzed the correlation between eradication rate and the DPM values.Results 1 General conditions:A total of 120 patients were enrolled,3 cases were lost to follow-up,including 1 case in the treatment group and 2 cases in the control group.There was no significant differences in gender,age,marital status,educational level,the place of residence,smoking history,drinking history between the two groups of patients（P>0.05）.2H.pylori eradication rate in the two groups of patients:According to the Intention-to-treat（ITT）analysis,the H.pylori eradication rates of the two groups were 88.3%in the treatment group and 85.0%in the control group.There was no significant difference in the eradication rates between the two groups（P>0.05）.According to the Per-protocol（PP）analysis,the eradication rates of the two groups were 89.8%in the treatment group and 87.9%in the control group.There was no significant difference in the eradication rates between the two groups（P>0.05）.3 The clinical efficacy of the two groups of patients:The overall effective rate of the treatment group was 93.2%,and the overall effective rate of the control group was 82.7%.There was a statistically significant difference in the overall effective rate between the two groups.4 Symptom relief in the two groups of patients:The symptom scores of the treatment group before treatment and 4 weeks after drug withdrawal were 7.90±1.98and 1.73±1.51,respectively.The symptom scores of the control group before treatment and four weeks after drug withdrawal were 6.62±2.29 and 2.93±1.95,respectively.The results of applying a two-way repeated measures ANOVA show that:There was a statistically significant difference in the main effect of time（P<0.05）.There was a significant difference in the main effect between groups（P<0.05）.and There was a statistically significant difference in the interaction effect between time and groups（P<0.05）.5 Adverse drug reaction rate in the two groups of patients:There were 21 patients in the two groups with adverse reactions,including 5 patients in the treatment group and 16 patients in the control group.The adverse drug reaction rates in the treatment group was 8.5%,and in the control group was 27.6%.The difference was statistically significant（P<0.05）.Among the adverse reactions,7 patients in the control group appeared a metallic taste in the mouth,but none in the treatment group,and the difference was statistically significant（P<0.05）.6 Correlation between H.pylori eradication rate and DPM value in two groups:The eradication rates of DPM subgroups A and B in the treatment group were 97.4%and 75.0%,respectively.The difference was statistically significant（P<0.05）.Conclusions 1 Xiaojianzhong Capsules combined with standard triple therapy had the same curative effect on H.pylori eradication as bismuth quadruple therapy.2 Xiaojianzhong Capsules combined with standard triple therapy can significantly relieve the clinical symptoms of H.pylori infection patients.3 Compared with bismuth quadruple therapy,Xiaojianzhong capsule combined with standard triple therapy can significantly reduce the adverse drug reactions during H.pylori treatment,especially in reducing the incidence of oral metallic taste.4 The eradication rate of H.pylori in the high DPM value group was low in the low value group.5 The cost of Xiaojianzhong capsule combined with standard triple therapy is higher than that of bismuth quadruple therapy.Figure 0;Table 11;Reference 127...