Clinical Study Of Helicobacter Pylori Eradication In7-,10-,14-day Furazolidone-containing Triple Therapy

Objective: Helicobacter pylori-related （Helicobacter pylori, H.pylori）diseases is a major global problem. Epidemiological studies have shown thatone-half of the population has the H. pylori approximately in the word. Chinais one of the countries with a high H.pylori infection rate. H.pylori detectionrate in natural crowd is40%～90%. It is associated with chronic gastritis,peptic ulcer disease, gastric cancer and gastric mucosa-associated lymphoidtissue lymphoma. In Maastricht Ⅳ/Florence Consensus Report and Thefourth national Helicobacter pylori infection consensus report,bismuth-containing quadruple treatment are recommended for first-lineempirical treatment. The Consensus also mentioned that PPI-containing tripletherapy is also recommended if in the region of low H.pylori resistance rate orpatient who have a contraindication to Bismuth[1,2]. However, of H.pylorispectrum resistance to antibiotics is still a lack in various countries andregions. It is still unknown whether traditional triple therapy is also suitablefor clinical application. In recent years, many studies show, thefurazolidone-containing triple therapy as initial treatment is better, but it isInfluential that different durations on the treatment effect[3].The aim of this study was to study the efficacy and safety of H.pylorieradication with7-,10-and14-day furazolidone-containing triple therapy inShijiazhuang, Hebei Province, and provide the basis for clinical reasonableeradicate H.pylori treatment program.Material and Method：1Patient selection: They were referred to the digestive department of theThird Hosipital of Hebei Medical University from October2011to January2013. A total of270patiens were included.1.1Selection criteria:①patients who were willing to cooperate and can be follow-up of persons aged18-75years old and were diagnosed by endoscopyand biopsy. They included chronic active gastristis, peptic ulcer and gastriccarcinoma. Functional dyspepsia were diagnosed according to Rome ⅢDiagnostic Criteria for Functional;②Rapid urease test or¹⁴C-urea breathtest had positive test results;③All patients were treated by eradication ofH.pylori for the first time.1.2Exclusion criteria:①In recently2weeks, have no use of proton pumpinhibitors （PPIs）, H₂receptor antagonists（H₂RA） and non-steroidalanti-inflammatory drugs（NSAID）, and in recently4weeks, have no use ofbismuth agents and antibiotics;②No serious heart, brain, liver, lung, renaldysfunction;③Non-pregnant and lactating women;④Not allergic to thedrugs used.1.3Termination test indications:①Symptom aggravated during the treatmentperiod;②Patients could not demonstrate compliance because of severe sideeffects;③Severe diseases were found during the treatment period;④lost tofollow-up;⑤Pregnancy during the treatment period.1.4Ordinary circumstances: A total of270patiens（133males and137females;median age,49years; range,18～75years） were included. There were94functional dyspepsia patients,95chronic active gastristis patients,81pepticulcer patients in the examination.2Methods2.1Grouping: Patients were randomly divided into three groups for H.pylorieradication therapy, respectively, as follows:Group A （7d triple group, n=90）: Application of esomeprazole （20mg bid）+amoxicillin （1000mg bid）+furazolidone （100mg bid）, for7day;Group B （10d triple group, n=90）: Application of the same medication anddaily dosage as Group A, for10d;Group C （14d triple group, n=90）: Application of the same medication anddaily dosage as Group A, for14d.2.2EfficacyBacterial eradication was diagnosed by¹⁴C-UBT when after4weeks the therapy had ended. And record the major side-effects accurately.2.3Statistical Analysis: SPSS13.0data statistical software was used forstatistical analysis. The comparison of the rate was analyzed by χ2test.Statistical significance was defined as a P <0.05.Results：1General information: The difference of A, B Aand C groups was significantin sex and disease classification （P>0.05）.（Table1.2.3.4）.2H.pylori eradication rate2.1Enroll condition: Group A:90cases were enrolled,2cases lost to follow,88cases have completed the whole course of treatment. The years ranged inage from18to75years with an average age of49.3±13.4years;63casessucceded and25cases failed in eradication.Group B:90cases were enrolled,1case lost to follow,1case of chronicnon-atrophic gastritis failed to complete the experiment because of nausea,and88cases have completed the whole course of treatment. The years rangedin age from22to73years with an average age of48.6±13.2years;72casessucceded and16cases failed in eradication.Group C:90cases were enrolled,2cases lost to follow,1case of chronicatrophic gastritis exited the experiment because of pruritus and erythra, and87cases have completed the whole course of treatment. The years ranged in agefrom19to74years with an average age of50.2±12.8years;76casessucceded and11cases failed in eradication.2.2H.pylori eradication rateAccording to per-protocol （PP） analysis, the H.pylori eradication rates of threegroup （A, B, C） were71.6%（63/88）,81.8%（72/88） and87.4%（76/87）,respectively. There were statistical differences in the three groups （P=0.029）.Among them there were significant differences between Group A and C（P=0.005）. But there was no statistical significance differences between GroupA and B, so were Group B and C （P=0.109,0.311）. According tointention-to-treat （ITT） analysis, the H.pylori eradication rates of three group（A, B, C） were70.0%（63/90）,80.0%（72/90） and84.4%（76/90）, respectively. The difference had not statistical significance （P=0.056）.（Table5.6.7.8.9）3Adverse drug reactions: The adverse reactions rates of the three groups were9.1%,8.0%and10.3%, respectively. The difference had not statisticalsignificance （P=0.86）. The main adverse reactions were diarrhea, abdominalpain, nausea, vomiting, loss of appetite and other gastrointestinal reactiones,dizziness, headache, oral odor, pruritus, erythra and orange coloured urine.1case of chronic non-atrophic gastritis from Group B failed to complete theexperiment because of nausea.1case of chronic atrophic gastritis from GroupC also exited the experiment because of pruritus and erythra. The adversereactions of the remaining patients were mild, without special treatment. Thesymptoms disappeared after the course of treatment.（Table10.11）Conclusion:1The14d triple therapy is more effective than the7d therapy for H pylorieradication，and the adverse reactions are not significantly increased.2The H.pylori eradication rate of esomeprazole combined withamoxicillin, furazolidone,14d triple therapy get up to87.4%, and it is worthpopularizing.3The H.pylori eradication is not affected by age, gender, smoking statusand classification of diseases.