Brighton and Sussex Medical School, Universities of Brighton & Sussex, Brighton, UK.
Barts Health NHS Trust and Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary, University of London, London, UK.
J Hosp Infect. 2020 Jun;105(2):280-288. doi: 10.1016/j.jhin.2020.01.018. Epub 2020 Feb 7.
Antibiotic-associated diarrhoea (AAD) is a side-effect of antibiotic consumption and probiotics have been shown to reduce AAD.
A multicentre, double-blind, placebo-controlled, randomized trial was conducted to evaluate the role of Lactobacillus casei DN114001 (combined as a drink with two regular yoghurt bacterial strains) in reducing AAD and Clostridioides difficile infection in patients aged over 55 years. The primary outcome was the incidence of AAD during 2 weeks of follow-up.
A total of 1127 patients (mean age ± standard deviation: 73.6 ± 10.5) were randomized to the active group (N = 549) or placebo group (N = 577). Both groups were followed up as per protocol. The proportion of patients experiencing AAD during follow-up was 19.3% (106/549) in the probiotic group vs 17.9% (103/577) in the placebo group (unadjusted odds ratio 1.10, 95% confidence interval 0.82-1.49, P = 0.53).
No significant evidence was found of a beneficial effect of the specific probiotic formulation in preventing AAD in this elderly population drawn from a number of different UK hospitals. However, in the UK and in many other healthcare systems there have, in recent years, been many changes in antibiotic stewardship policies, an overall decrease in incidence in C. difficile infection, as well as an increased awareness of infection prevention, and modifications in nursing practice. In light of these factors, it is impossible to conclude definitively from the current trial that the study-specific probiotic formulation has no role in preventing AAD, and it is our view that further trials may be indicated, controlling for these variables.
抗生素相关性腹泻（AAD）是抗生素使用的一种副作用，而益生菌已被证明可减少 AAD。
进行了一项多中心、双盲、安慰剂对照、随机试验，以评估干酪乳杆菌 DN114001（与两种常规酸奶细菌菌株混合制成饮料）在减少 55 岁以上患者的 AAD 和艰难梭菌感染中的作用。主要结局是在 2 周随访期间 AAD 的发生率。
共有 1127 名患者（平均年龄±标准差：73.6±10.5）被随机分为活性组（N=549）或安慰剂组（N=577）。两组均按方案进行随访。在随访期间，益生菌组发生 AAD 的患者比例为 19.3%（106/549），安慰剂组为 17.9%（103/577）（未调整的优势比 1.10，95%置信区间 0.82-1.49，P=0.53）。
在从英国多家医院抽取的老年人群中，没有发现特定益生菌配方在预防 AAD 方面有显著益处的证据。然而，近年来，在英国和许多其他医疗保健系统中，抗生素管理政策发生了许多变化，艰难梭菌感染的总体发病率下降，感染预防意识提高，护理实践也发生了变化。鉴于这些因素，从目前的试验中，我们无法明确得出研究特定的益生菌配方在预防 AAD 方面没有作用的结论，我们认为可能需要进一步的试验，控制这些变量。
