Henker Jobst, Laass Martin W, Blokhin Boris M, Maydannik Vitaliy G, Bolbot Yuriy K, Elze Martina, Wolff Corinna, Schreiner Armin, Schulze Jürgen
Department of Pediatrics, University Carl-Gustav-Carus, Dresden, Germany.
Pediatr Infect Dis J. 2008 Jun;27(6):494-9. doi: 10.1097/INF.0b013e318169034c.
Administering probiotics can prevent or cure some forms of diarrhea. The efficacy of probiotic Escherichia coli Nissle 1917 (EcN) in infants and toddlers with diarrhea >4 days was tested by a double-blind trial.
One hundred fifty-one children aged 1-47 months with nonspecific diarrhea were randomized to receive either EcN suspension (N = 75) or placebo (N = 76). Diarrhea had to meet the following definition: >3 watery or loose nonbloody stools in 24 hours of a diarrheal episode persisting for >4 consecutive days but < or =14 days. All children were well nourished or only moderately malnourished, mildly dehydrated, and received oral rehydration at study commencement. They were treated orally with 1-3 mL EcN suspension (1 mL contains 10 viable cells) or placebo daily for 21 days. Primary objective was to confirm a better response rate (reduction of daily stool frequency to < or =3 watery or loose stools over > or =4 days) with EcN.
The 7-day response was higher for the EcN group than placebo (EcN 78.7%, placebo 59.2%). Significant differences were observed on days 14 (EcN 93.3%, placebo 65.8%, P = 0.0017) and 21 (EcN 98.7%, placebo 71.1%, P < 0.001). Kaplan-Meier survival analysis resulted in a significant difference of 3.3 days between the groups (P < 0.0001); median time to response for EcN was 2.4 and 5.7 for placebo. EcN was safe and well tolerated.
In the conditions of this trial EcN was a suitable remedy for diarrhea >4 days in young children.
服用益生菌可预防或治愈某些类型的腹泻。通过一项双盲试验测试了益生菌大肠杆菌Nissle 1917（EcN）对腹泻超过4天的婴幼儿的疗效。
151名年龄在1 - 47个月的非特异性腹泻儿童被随机分为两组，分别接受EcN悬浮液（N = 75）或安慰剂（N = 76）。腹泻必须符合以下定义：在持续超过4天但≤14天的腹泻发作期间，24小时内有>3次水样或稀软非血性大便。所有儿童营养状况良好或仅为中度营养不良，轻度脱水，且在研究开始时接受口服补液。他们每天口服1 - 3 mL EcN悬浮液（1 mL含10个活细胞）或安慰剂，持续21天。主要目的是确认EcN的反应率更高（在≥4天内将每日大便频率降至≤3次水样或稀软大便）。
EcN组的7天反应率高于安慰剂组（EcN为78.7%，安慰剂为59.2%）。在第14天（EcN为93.3%，安慰剂为65.8%，P = 0.0017）和第21天（EcN为98.7%，安慰剂为71.1%，P < 0.001）观察到显著差异。Kaplan - Meier生存分析显示两组之间存在3.3天的显著差异（P < 0.0001）；EcN的中位反应时间为2.4天，安慰剂为5.7天。EcN安全且耐受性良好。
在本试验条件下，EcN是治疗幼儿腹泻超过4天的合适药物。
