Objective: To assess the efficacy and safety of Saccharomyces boulardii (S. boulardii) in combination with triple therapy as a first-line regimen for the eradication of Helicobacter pylori (H. pylori) in non-ulcer dyspepsia (NUD) patients. Methods: A total of 497 Helicobacter pylori-positive patients who underwent gastroscopy and diagnosed with NUD were enrolled from June 2018 to January 2020 in 9 medical centers across China. Participants were segmentedly randomly divided into 3 groups. Patients in group A received S. boulardii for 14 days and triple therapy for 10 days, while patients in group B received bismuth quadruple group for 10 days, and patients in group C received triple therapy for 10 days. The H. pylori status was determined by the 13C-urea breath test on the 44th day of the treatment. Symptom improvement and adverse reactions were assessed on the 14th and 44th day. Results: There were 229 males and 268 females in all 497 patients enrolled. They were aged 18-69 (46.1±11.8) years and 472 of them (158 cases in group A, 159 cases in group B, and 155 cases in group C) completed the trial. The intention-to-treat (ITT) eradication rates in patients in patients A, B and C were 77.8% (126/162), 80.1% (137/171) and 65.2% (107/164) respectively, and per protocol-based (PP) eradication rates were 79.7% (126/158), 86.2% (137/159) and 69.0% (107/155) respectively. The differences were statistically significant in ITT and PP analysis among 3 groups (ITT: χ²=11.14, P<0.01; PP: χ²=13.86, P<0.01). There was no significant difference between eradication rates of two quadruple therapys(all P>0.05), but both of them were significantly higher than that of standard triple therapy (both P<0.05). Statistics revealed that both quadruple therapys led to significantly higher symptom improvement of belching compared with that of standard triple therapy in day 14 (P<0.05). The relief of abdominal distension and belching symptom scores of group A were significantly higher than those of group C in day 44(all P<0.05). There was no serious adverse event reported. The incidence of diarrhea in group A was significantly lower than those in the other two groups (both P<0.05). Conclusions: The combination of S. boulardii and triple therapy can achieve a better eradication effect on H. pylori infection with NUD, and has advantages in symptom relief and safety.
目的： 观察布拉氏酵母菌散联合三联疗法作为一线方案对幽门螺杆菌（H. pylori）感染的根除治疗效果及安全性。 方法： 纳入2018年6月至2020年1月全国9个中心接受胃镜检查并诊断非溃疡性消化不良（NUD）的H. pylori阳性患者共497例，采用分段随机法分为3组，进行H. pylori初次根除治疗。A组采用布拉氏酵母菌散+三联疗法（10 d后继续仅予布拉氏酵母菌至14 d）；B组采用铋剂四联疗法（10 d）；C组采用三联疗法（10 d）。患者均在第44天行13C-尿素呼气试验。分别观察H. pylori根除率、第14及44天症状改善情况和不良反应。 结果： 纳入的497例患者中，男229例，女268例，年龄18~69（46.1±11.8）岁，共472例（A组158例、B组159例、C组155例）完成试验。意向性（ITT）分析：A组H. pylori根除率为77.8%（126/162），B组为80.1%（137/171），C组为65.2%（107/164）。符合方案集（PP）分析：A组根除率为79.7%（126/158），B组为86.2%（137/159），C组为69.0%（107/155）。三组间ITT及PP分析差异均有统计学意义（ITT：χ2=11.14，P<0.01；PP：χ2=13.86，P<0.01）。各组两两比较，ITT及PP分析A、B组之间差异均无统计学意义（均P>0.05），A组和B组与C组比较差异均有统计学意义（均P<0.05）。在第14天时，A、B组嗳气症状评分缓解程度与C组差异均有统计学意义（均P<0.05）。第44天时，A组腹胀、嗳气症状评分缓解程度与C组差异均有统计学意义（均P<0.05）。所有纳入本研究患者均无严重不良反应事件发生。A组腹泻发生率低于另外两组（均P<0.05）。 结论： 布拉氏酵母菌散联合三联疗法作为一线方案对NUD患者初次H. pylori治疗具有较好的根除效果，并在症状缓解上有优势，具有较好的耐受性和临床安全性。.