| Objective:The efficacy and safety of different probiotics in the eradication of h.pylori in children were compared by randomized controlled trial,providing theoretical basis for future clinical diagnosis and treatmentMethods:From July 2020 to January 2022,117 newly treated children with H.pylori infection in our hospital were randomly assigned to three groups: standard control group(group A),S.boulardii powder group(group B)and compound Lactobacillus acidophilus group(Group C),The standard control group were given first-line treatment(clarithromycin15-20 mg / kg.D bid + amoxicillin 50 mg / kg.D bid + omeprazole 0.8-1.0mg / kg.D bid);Saccharomyces boulardii powder group:(first line scheme + Saccharomyces boulardii powder,250 mg / time bid);Compound Lactobacillus acidophilus group:(first-line regimen + compound Lactobacillus acidophilus,500 mg / time TID);Clinical symptom relief and adverse reactions after drug use were recorded at 0 days,2 weeks and 4 weeks after drug withdrawal in each case.H.pylori eradication was assessed by 13 C urea breath test(13C-UBT)4 weeks after completion of eradication.BOD value < 4 indicates the success of H.pylori eradication,and BOD value ≥ 4 indicates the failure of H.pylori eradication.SPSS25.0 was used to statistically analyze the curative effect of treatment regimen A,B and C on h.pylori eradication rate,clinical symptom relief and adverse reactions.Results:1.117 children were included in this trial,including 39 in group A,40 in group B and 38 in group C.A total of 4 cases were lost to follow-up,and the rest completed treatment without interruption of treatment.Group A: 17 males and 22 females,with an average age of 10.36 ± 1.98(years);Group B: 21 males and 19 females,with an average age of 10.18 ± 2.12(years);group C: 20 males and 18 females,with an average age of9.84 ± 1.79(years): the results showed that there was no significant difference in gender and age among the three groups(P > 0.05).2.A total of 113 children completed treatment and follow-up,and 13C-UBT was rechecked on time.A total of 94 cases were successfully eradicated.The overall eradication rate was 80.3%(94/117)according to the ITT analysis and 83.1%(94/113)according to the PP analysis.According to ITT analysis,the highest eradication rate was90.0% in group B,84.2% in group C and 66.6% in group A.There was a statistically significant difference in the eradication rate among the three groups(P=0.025,P>0.05).According to PP analysis,the highest eradication rate was 92.3% in group B,88.9% in group C and 68.4% in group A.There was significant difference in eradication rate among the three groups(P = 0.011,P < 0.05).Then according to ITT analysis for pairwise comparison,P<0.0167 indicated a statistically significant difference,the results showed that there was a statistically significant difference between group A and group B(P=0.012,P<0.0167),and there was no difference between group A and group C(P=0.074,P>0.0167),there was no significant difference between group B and group C(P=0.512,P>0.0167).The results showed that the eradication rate of group B was higher than that of group A.Then according to PP analysis,pairwise comparisons were made,P<0.0167 indicated a statistically significant difference,the results showed that there was a statistically significant difference between group A and group B(P=0.008,P<0.0167),and there was no difference between group A and group C(P=0.033,P>0.0167),there was no significant difference between group B and group C(P=0.704,P>0.0167).The results also suggested that the eradication rate of group B was higher than that of group A.3.The incidence of adverse reactions was 34.2% in group A,10.2% in group B and8.3% in group C,with significant differences among the three groups(P <0.05).Pairwise comparison among the three groups showed that there was significant difference between group B and group A(P < 0.0167),adverse reactions of group B were significantly lower than that of group A,the difference between group C and group A was significant(P < 0.0167),adverse reactions of group C were significantly lower than that of group A,but there was no significant difference between group B and group C(P >0.0167).4.The comparison of clinical symptoms of adverse reactions showed that diarrhea and nausea had significant differences among the three groups(P < 0.05).Continue to analyze the two subgroups of diarrhea,P < 0.0167 showed that the difference was statistically significant.The results showed that there was significant difference between group B and group A(P = 0.010,P < 0.0167),significant difference between group A and group C(P = 0.004,P < 0.0167),and no significant difference between group B and group C(P=1.000).The results indicated that both groups could significantly reduce diarrhea symptoms.Pairby comparison of nausea symptoms,P < 0.0167 showed statistically significant difference,there was no significant difference between group A and group B(P=0.0.082,P > 0.0167),significant difference between group A and group C(P=0.005,P < 0.0167),and no significant difference between group B and group C(P=0.494).These results suggest that group C has an advantage in alleviating nausea symptoms.5.There was no significant difference in clinical symptom scores among the three groups at different time points(P > 0.05).Anova of repeated measures found significant differences in clinical symptom scores in the main effect of time(P=0.001)..It can be seen from(Fig.2)that the clinical symptoms of the three groups were significantly relieved over time.The analysis showed that there was no significant difference in the interaction effect of time and treatment scheme on the relief of clinical symptoms(P =0.312),suggesting that different treatment schemes had no significant effect on the relief of clinical symptoms.Conclusion:1.According to the ITT analysis,the overall eradication rate was 80.3%,and according to the PP analysis,the overall eradication rate was 83.1%,which was similar to the eradication rate in domestic and foreign literature.2.The supplementation of Saccharomyces brassi powder could improve the eradication rate of H.pylori,but compound Lactobacillus acidophilus could not significantly improve the eradication rate of H.pylori;3.Both saccharomyces brassi powder and compound Lactobacillus acidophilus can effectively reduce the incidence of adverse reactions,mainly reducing the symptoms of diarrhea and nausea,and the effect of compound Lactobacillus acidophilus in reducing nausea is more obvious;4.Through treatment,the clinical symptoms of children were significantly relieved over time,but there was no difference in clinical symptom relief due to different treatment schemes. |
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