Objective: To assess the efficacy and safety of different opportunity of Saccharomyces boulardii (S. Boulardii) Sachets combined with bismuth quadruple therapy for Helicobacter pylori(H. pylori)eradication. Methods: This experiment was a prospective study. A total of 300 H. pylori-infected patients were enrolled and randomized assigned into three groups. Quadruple therapy group received pantoprazole 40 mg+bismuth potassium citrate capsule 220 mg+amoxicillin 1 000 mg+furazolidone 100 mg, bid, oral for 14 days. The simultaneous probiotic group received pantoprazole 40 mg+bismuth potassium citrate capsule 220 mg+amoxicillin 1 000 mg+furazolidone 100 mg+S. Boulardii Sachets 500 mg,bid,oral for 14 days.There after probiotic group:S.Boulardii Sachets was added on the first day after the end of 14 days in the quadruple group, for 500 mg, bid 14 days. The eradication rates and adverse reactions of the three groups were compared. Results: The eradication rates of H.pylori were 89.0%,90.4% and 91.3% in the quadruple therapy group, the simultaneous probiotic group and the there after probiotic group according to Per-protocol(PP) analysis,respectively,with no statistical difference (P=0.870). According to intention-to-treat(ITT)analysis, 81.0%, 85.0% and 84.0%, respectively, the difference was not statistically significant (P=0.732).The overall incidence of adverse reactions and the incidence of diarrhea and nausea in the simultaneous probiotic group, and the there after probiotic group were lower than those in the quadruple group(P<0.05),and the difference was statistically significant.The overall incidence of adverse reactions and diarrhea in the simultaneous probiotic were lower than those in the there after probiotic group (P=0.021, P=0.007), and the difference was statistically significant. Conclusions: S. Boulardii Sachets combined with quadruple therapy at the same time or after eradication treatment can not improve the H.pylori eradication rate,but can reduce the overall incidence of adverse reactions and the incidence of diarrhea and nausea. It is safer to add S. Boulardii Sachets at the same time than after eradication therapy.
目的： 评价不同时机加用布拉氏酵母菌（S.Boulardii）散剂联合四联疗法根除幽门螺杆菌（H.pylori）的有效性和安全性。 方法： 共300例H.pylori阳性患者纳入本前瞻性研究，随机分为3组，四联组：泮托拉唑40 mg+枸橼酸铋钾220 mg+阿莫西林1 000 mg+呋喃唑酮100 mg，口服，2次/d，疗程14 d；同期益生菌组：泮托拉唑40 mg+枸橼酸铋钾220 mg+阿莫西林1 000 mg+呋喃唑酮100 mg+S. Boulardii散剂500 mg，口服2次/d，疗程14 d；后期益生菌组：在四联组14 d结束后第1天开始，加用S. Boulardii散剂500 mg，2次/d，口服14 d。观察患者不良反应，疗程结束4周后观察H.pylori根除率。 结果： 四联组、同期益生菌组、后期益生菌组H.pylori根除率按方案（PP）分析分别为89.0%、90.4%、91.3%，差异无统计学意义（P=0.870）；按意向性（ITT）分析分别为81.0%、85.0%、84.0%，差异无统计学意义（P=0.732）；同期益生菌组、后期益生菌组不良反应的总体发生率及腹泻、恶心的发生率均低于四联组（P<0.05），差异有统计学意义。同期益生菌组不良反应的总体发生率以及腹泻发生率低于后期益生菌组（P=0.021，P=0.007），差异有统计学意义。 结论： 同时期或根除治疗后加用S. Boulardii散剂联合四联疗法均不能提高H.pylori根除率，但均可降低不良反应总体发生率和腹泻、恶心的发生率；同时期较根除治疗后加用S. Boulardii散剂联合四联疗法更安全。.
Keywords: Bismut; Helicobacter pylori; Yeasts.