| Objective: Helicobacter pylori (H.pylori) infection is closely associatedwith the upper gastrointestinal disease. H.pylori is the most successful humanpathogen infecting an estimated50%of the global population, in developingcountries H.pylori infection rate is higher than that in developed countries,H.pylori infection has become a global issue. H.pylori infection rate is54.76%in Chinese natural population which maintains a high level overall[1]. H.pylorieradication rate of standard triple therapy gradually decreases due toincreasing antimicrobial resistance and treatment-related side effects. In2012Fourth National Consensus on Helicobacter pylori infection treatment andMaastricht Ⅳ/Florence Consensus Report, bismuth, proton pump inhibitors,two kinds of antibiotics-containing quadruple therapies are recommended forinitial treatment in regions of high clarithromycin resistance[2-3], but the sideeffects caused by the bismuth agent itself and bismuth combinate withhigh-dose antibiotics, cannot be ignored. Certain probiotics show promisingresults combining with triple therapy in improving H.pylori eradication rateand reducing side effects[4]. However, the type of species or strains seriouslyaffect therapeutic effect of probiotics.This study aimed to assess the efficacy and safety of bacterialprobiotics-Compound Eosinophil-Lactobacillus Tablets and fungi type ofprobiotics-Saccharomyces boulardii (S. Boulardii) Sachets combined withstandard triple therapy for H.pylori eradication, to assess the clinical effects ofprobiotics as an adjuvant treatment in H.pylori eradication.Materials and Methods:1Patient selection: A total of240H.pylori infected patiens were chooseedfrom November2012to January2014in the Third Hospital of Hebei MedicalUniversity, Department of Gastroenterology. 1.1Inclusion Criteria:①Between the ages of18to70years, rapid urease testor14C-urea breath test (14C-UBT) or13C-urea breath test (13C-UBT) hadresults for H.pylori positive;②Patients were diagnosed with peptic ulcer,chronic active gastritis by electronic endoscopy and biopsy or patients werediagnosed with functional dyspepsia;③Patientshad not received antibiotics,bismuth agents in the4weeks before treatment and had not received protonpump inhibitors, H2receptor antagonists (H2RA) in recently2weeks;④Patients had not previous history of regular H.pylori eradication therapy.⑤A llpatients were informed and consent before enrolling the study protocol.1.2Exclusion criteria:①Patients with serious heart, brain, lung, liver, kidneydysfunction, autoimmune conditions immunocompromised;②Patients whowere allergic to the study drugs;③P regnant or lactatingwomen.2Methods2.1Grouping: All patients met the inclusion criteria were randomly dividedinto A, B, C three groups for H.pylori eradication therapy, respectively. GroupA was triple group,80cases; Group B was CompoundEosinophil-Lactobacillus Tablets group,80cases; Group C was S. BoulardiiSachets group,80cases.Group A (Triple group, n=80): Received esomeprazole (20mg bid)+amoxicillin (1000mg bid)+furazolidone (100mg bid), for10day;Group B (Compound Eosinophil-Lactobacillus Tablets group, n=80):Received the same triple therapy for10days as group A, and plusedCompound Eosinophil-Lactobacillus Tablets (1000mg, tid) for14days;Group C (S. Boulardii Sachets group, n=80): Received the same tripletherapy for10days as group A, and plused S. Boulardii Sachets (500mg, bid)for14days.2.2Efficacy: H.pylori eradication rate was assessed by14C-UBT or13C-UBT,four weeks after the course of treatment. The adverse reactions and thetolerance degree of drug in patients were observed and recorded during thetherapy.2.3Statistical Analysis: Application SPSS13.0statistical software for analysis. The comparison of the rate was analyzed by χ2test. The comparison of theranked data was analyzed by Kruskal-Wallis H test.P <0.05was consideredstatistically significant.Results:1General information:240cases of patients were enrolled, with an averageage of48.0years (18to70years). Seven were lost to follow-up in total, twopatients were lost in group A,3patients were lost in group B,2patients werelost in group C; None of them terminated the experiment; Patients in eachgroup showed no significant difference in age, gender, disease classification;(P>0.05)(Table1-3).2H.pylori eradication rate: There were80patientse in every group. TheH.pylori eradication rates by Per-protocol(PP) analysis were64.1%(50/78),79.2%(61/77),85.9%(67/78), respectively, by intention-to-treat (ITT)analysisin groups A, B and C were62.5%(50/80),76.3%(61/80),83.8%(67/80),respectively. The H.pylori eradication rate in group B was significantly higherthan that in group A by PP analysis (P=0.037), but on significant differencewas seen by ITT analysis (P=0.059). In group C was significantly higher thanthat in group A by PP and ITT analysis (P=0.002, P=0.002). But on significantdifference was seen in group C and B by ITT and PP analysis (P=0.273, P=0.236)(Table4-7).3Adverse drug reactions: In A, B, C group, the main adverse reactions wereabdominal distension, diarrhea, nausea, abdominal pain, orange coloured urine.The adverse reactions rates of the three groups were34.6%,19.5%,7.7%,respectively. The incidence of adverse reactions was significantly lower ingroup B and group C than that in group A (P=0.034, P=0.000), group C wassignificantly lower than that in group B (P=0.032). All adverse effects had notbe given special treatment and gradually disappeared after stopping thetreatment (Table8-9).4The tolerance degree of drug: The tolerance degree of drug in group B,group C was significantly higher than that in group A(P=0.033, P=0.000),group C was significantly higher than that in group B(P=0.027)(Table10). Conclusion:1Compound Eosinophil-Lactobacillus Tablets or S. Boulardii Sachetscombined with Triple Therapy can increase the eradication rate of H.pylori,reduce side effects and improve the degree of drug tolerance.2Compound Eosinophil-Lactobacillus Tablets or S. Boulardii Sachetscombined with Triple Therapy is used for H.pylori eradication, the latter ismore secure than the former. |
PDF Full Text Request