布拉酵母菌对幽门螺杆菌感染补救治疗的影响

Effect of Saccharomyces boulardii on Rescue Therapy of Helicobacter pylori Infection

背景:近年来,由于菌株变异、耐药、不同菌株交叉感染等诸多因素,标准三联疗法的幽门螺杆菌(Hp)根除率已降至80%以下。随着初次根除失败病例的增加,探索新的补救方案已成为临床工作的重点。目的:探讨布拉酵母菌联合含莫西沙星三联疗法在Hp感染补救治疗中的疗效和安全性。方法:收集经铋剂四联疗法初次根除治疗失败的慢性胃炎患者400例,随机分为两组,对照组(n=200)接受埃索美拉唑+阿莫西林+莫西沙星三联补救治疗,试验组(n=200)在对照组的基础上加用布拉酵母菌散,疗程均为14 d。停药4周后以13C/14C-尿素呼气试验判断Hp根除情况,治疗期间随访不良反应发生情况。结果:对照组和试验组Hp根除率按方案(PP)分析分别为80.1%(121/151)和90.4%(142/157),按意向治疗(ITT)分析分别为60.5%(121/200)和71.0%(142/200),试验组PP和ITT根除率均显著高于对照组(P<0.05),不良反应发生率显著低于对照组(9.6%对17.9%,P<0.05)。结论:布拉酵母菌联合含莫西沙星三联补救疗法可显著提高Hp感染补救治疗的根除率,降低不良反应发生率。

Background： In recent years,the eradication rate of standard triple therapy for Helicobacter pylori（ Hp） infection has been reduced to less than 80% because of many factors,such as strain variation,drug resistance and cross infection of different strains. As more and more cases with failure of initial eradication therapy,the focus of clinical practice is to explore new alternative rescue therapies. Aims： To assess the efficacy and safety of Saccharomyces boulardii combined with moxifloxacin-based triple regimen for rescue therapy of Hp infection. Methods： A total of 400 patients with chronic gastritis who had failed initial bismuth quadruple therapy were enrolled and randomly assigned into two groups： 200 cases of control group and 200 cases of test group. Patients in control group received a rescue triple therapy（ esomeprazole,amoxicillin and moxifloxacin） for 14 days and those in test group with the further addition of Saccharomyces boulardii sachets. Hp eradication was assessed by ^13C/^14C-urea breath test four weeks after treatment,and the adverse events during treatment course were observed. Results： The Hp eradication rates in control group and test group were 80. 1%（ 121/151） and90. 4%（ 142/157） by per-protocol（ PP） analysis,respectively,and 60. 5%（ 121/200） and 71. 0%（ 142/200） by intention-to-treat（ ITT） analysis,respectively. The eradication rate in test group was significantly higher than that in control group by both PP and ITT analyses（ P〈0. 05）. The incidence rate of adverse events was significantly lower in test group than in control group（ 9. 6% vs. 17. 9%,P〈0. 05）. Conclusions： Saccharomyces boulardii added to moxifloxacinbased rescue triple therapy could increase the eradication rate of Hp infection with less adverse events.