Nista E C, Candelli M, Cremonini F, Cazzato I A, Zocco M A, Franceschi F, Cammarota G, Gasbarrini G, Gasbarrini A
Department of Internal Medicine, Catholic University, Rome, Italy.
Aliment Pharmacol Ther. 2004 Nov 15;20(10):1181-8. doi: 10.1111/j.1365-2036.2004.02274.x.
Helicobacter pylori eradication fails in about 10% of patients, particularly because of the occurrence of resistance to antibiotics and side-effects. During anti-H. pylori therapy, probiotics have been successfully used to reduce the incidence of side-effects.
To evaluate the effect of Bacillus clausii, a probiotic, on incidence (primary variable) and severity of antibiotic-associated side-effects during anti-H. pylori therapy.
One hundred and twenty H. pylori-positive patients were randomly screened to receive: (i) a standard 7 days triple therapy with rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and amoxicillin 1 g b.d. and B. clausii t.d.s. (each preparation containing 2 x 10(9) spores) for 14 days starting from the first day of treatment. (ii) The same 7 days triple therapy and placebo t.d.s. for 14 days starting from the first day of treatment. Side-effects were assessed using a validated questionnaire and were recorded for 4 weeks from the start of therapy.
The incidences of nausea, diarrhoea and epigastric pain in patients treated with B. clausii were significantly lower than in placebo group, in both PP and ITT analysis. Equally, intensity of nausea and diarrhoea in patients treated with B. clausii was significantly lower than in placebo group. There were no differences in adherence to treatment and H. pylori eradication rates between groups. Conclusion : In symptom-free, H. pylori-positive subjects B. clausii bacteriotherapy reduces the incidence of the most common side-effects related to anti-H. pylori antibiotic therapy compared with placebo.
幽门螺杆菌根除治疗在约10%的患者中失败，尤其是由于出现抗生素耐药性和副作用。在抗幽门螺杆菌治疗期间，益生菌已成功用于降低副作用的发生率。
评估益生菌克劳氏芽孢杆菌对抗幽门螺杆菌治疗期间抗生素相关副作用的发生率（主要变量）和严重程度的影响。
随机筛选120例幽门螺杆菌阳性患者，使其接受：（i）标准的7天三联疗法，即雷贝拉唑20毫克，每日两次，克拉霉素500毫克，每日两次，阿莫西林1克，每日两次，以及克劳氏芽孢杆菌，每日三次（每种制剂含2×10⁹个孢子），从治疗第一天开始持续14天。（ii）相同的7天三联疗法和安慰剂，每日三次，从治疗第一天开始持续14天。使用经过验证的问卷评估副作用，并从治疗开始记录4周。
在PP和ITT分析中，接受克劳氏芽孢杆菌治疗的患者中恶心、腹泻和上腹部疼痛的发生率均显著低于安慰剂组。同样，接受克劳氏芽孢杆菌治疗的患者中恶心和腹泻的严重程度也显著低于安慰剂组。两组之间在治疗依从性和幽门螺杆菌根除率方面没有差异。结论：在无症状的幽门螺杆菌阳性受试者中，与安慰剂相比，克劳氏芽孢杆菌生物疗法可降低与抗幽门螺杆菌抗生素治疗相关的最常见副作用的发生率。
