Canani Roberto Berni, Cirillo Pia, Terrin Gianluca, Cesarano Luisa, Spagnuolo Maria Immacolata, De Vincenzo Anna, Albano Fabio, Passariello Annalisa, De Marco Giulio, Manguso Francesco, Guarino Alfredo
Department of Paediatrics, University of Naples Federico II, Naples, Italy.
BMJ. 2007 Aug 18;335(7615):340. doi: 10.1136/bmj.39272.581736.55. Epub 2007 Aug 9.
To compare the efficacy of five probiotic preparations recommended to parents in the treatment of acute diarrhoea in children. Design Randomised controlled clinical trial in collaboration with family paediatricians over 12 months.
Primary care.
Children aged 3-36 months visiting a family paediatrician for acute diarrhoea.
Children's parents were randomly assigned to receive written instructions to purchase a specific probiotic product: oral rehydration solution (control group); Lactobacillus rhamnosus strain GG; Saccharomyces boulardii; Bacillus clausii; mix of L delbrueckii var bulgaricus, Streptococcus thermophilus, L acidophilus, and Bifidobacterium bifidum; or Enterococcus faecium SF68.
Primary outcomes were duration of diarrhoea and daily number and consistency of stools. Secondary outcomes were duration of vomiting and fever and rate of admission to hospital. Safety and tolerance were also recorded.
571 children were allocated to intervention. Median duration of diarrhoea was significantly shorter (P<0.001) in children who received L rhamnosus strain GG (78.5 hours) and the mix of four bacterial strains (70.0 hours) than in children who received oral rehydration solution alone (115.0 hours). One day after the first probiotic administration, the daily number of stools was significantly lower (P<0.001) in children who received L rhamnosus strain GG and in those who received the probiotic mix than in the other groups. The remaining preparations did not affect primary outcomes. Secondary outcomes were similar in all groups.
Not all commercially available probiotic preparations are effective in children with acute diarrhoea. Paediatricians should choose bacterial preparations based on effectiveness data.
Current Controlled Trials ISRCTN56067537 [controlled-trials.com].
比较向家长推荐的五种益生菌制剂治疗儿童急性腹泻的疗效。设计：与家庭儿科医生合作进行为期12个月的随机对照临床试验。
初级保健机构。
因急性腹泻就诊于家庭儿科医生的3至36个月大儿童。
儿童家长被随机分配接受书面指示以购买特定益生菌产品：口服补液盐（对照组）；鼠李糖乳杆菌GG株；布拉酵母菌；克劳氏芽孢杆菌；德氏保加利亚乳杆菌、嗜热链球菌、嗜酸乳杆菌和双歧双歧杆菌的混合物；或粪肠球菌SF68。
主要结局为腹泻持续时间、每日大便次数及性状。次要结局为呕吐和发热持续时间及住院率。还记录了安全性和耐受性。
571名儿童被分配至干预组。接受鼠李糖乳杆菌GG株（78.5小时）和四种菌株混合物（70.0小时）的儿童腹泻中位持续时间显著短于仅接受口服补液盐的儿童（115.0小时）（P<0.001）。首次服用益生菌一天后，接受鼠李糖乳杆菌GG株和益生菌混合物的儿童每日大便次数显著低于其他组（P<0.001）。其余制剂未影响主要结局。所有组的次要结局相似。
并非所有市售益生菌制剂对急性腹泻儿童均有效。儿科医生应根据有效性数据选择细菌制剂。
Current Controlled Trials ISRCTN56067537 [controlled-trials.com]
