METHODS: This randomized, double-blinded, placebo-controlled trial involved treatment-naïve H. pylori-positive patients. Ninety patients received standard triple therapy for 2 weeks before receiving either a probiotic or placebo for 4 weeks. The posttreatment eradication rate was assessed via a 14 C urea breath test in Week 8. The Gastrointestinal Symptom Rating Scale (GSRS) questionnaire and an interview on treatment adverse effects were conducted during this study.
RESULTS: The eradication rate was higher in the probiotic group than in the placebo group, with a 22.2% difference in the intention-to-treat analysis (91.1% vs. 68.9%; p = 0.007) and 24.3% difference in the per-protocol analysis (93.2% vs. 68.9%; p = 0.007). The probiotic group showed significant pre- to post-treatment reductions in indigestion, constipation, abdominal pain, and total GSRS scores. The probiotic group showed significantly greater reductions in GSRS scores than the placebo group: indigestion (4.34 ± 5.00 vs. 1.78 ± 5.64; p = 0.026), abdominal pain (2.64 ± 2.88 vs. 0.89 ± 3.11; p = 0.007), constipation (2.34 ± 3.91 vs. 0.64 ± 2.92; p = 0.023), and total score (12.41 ± 12.19 vs. 4.24 ± 13.72; p = 0.004). The probiotic group reported significantly fewer adverse headache (0% vs. 15.6%; p = 0.012) and abdominal pain (0% vs. 13.3%; p = 0.026) effects.
CONCLUSIONS: There was a significant increase in H. pylori eradication rate and attenuation of symptoms and adverse treatment effects when L. reuteri was given as an adjunct treatment.
方法:这是随机的,双盲,安慰剂对照试验涉及初治幽门螺杆菌阳性患者。90名患者接受标准三联疗法2周,然后接受益生菌或安慰剂4周。在第8周通过14C尿素呼气试验评估治疗后根除率。在这项研究中,进行了胃肠道症状评定量表(GSRS)问卷和对治疗不良反应的访谈。
结果:益生菌组的根除率高于安慰剂组,在意向治疗分析中差异为22.2%(91.1%与68.9%;p=0.007)和24.3%的差异在符合方案分析中(93.2%与68.9%;p=0.007)。益生菌组显示出治疗前后消化不良的显着减少,便秘,腹痛,和GSRS总分。与安慰剂组相比,益生菌组的GSRS评分降低幅度更大:消化不良(4.34±5.00vs.1.78±5.64;p=0.026),腹痛(2.64±2.88vs.0.89±3.11;p=0.007),便秘(2.34±3.91vs.0.64±2.92;p=0.023),和总分(12.41±12.19vs.4.24±13.72;p=0.004)。益生菌组报告的不良头痛明显减少(0%vs.15.6%;p=0.012)和腹痛(0%vs.13.3%;p=0.026)效应。
结论:当罗伊氏乳杆菌作为辅助治疗时,幽门螺杆菌的根除率和症状的减轻以及不良治疗效果显著增加。