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日托儿童腹泻的急诊科治疗：瑞士乳杆菌和鼠李糖乳杆菌联合益生菌的随机多剂量试验

Emergency Department Treatment of Children With Diarrhea Who Attend Day Care: A Randomized Multidose Trial of a Lactobacillus helveticus and Lactobacillus rhamnosus Combination Probiotic.

作者信息

Freedman Stephen B, Sherman Philip M, Willan Andrew, Johnson David, Gouin Serge, Schuh Suzanne

机构信息

Alberta Children's Hospital, Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada

The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.

出版信息

Clin Pediatr (Phila). 2015 Oct;54(12):1158-66. doi: 10.1177/0009922815569200. Epub 2015 Feb 10.

DOI:10.1177/0009922815569200

PMID:25669920

Abstract

BACKGROUND

Benefits associated with probiotic administration to children seeking emergency department care with diarrheal disease are unknown.

METHODS

In this 3-site, double-blind, placebo-controlled study, children aged 4 to 48 months with gastroenteritis were randomized to receive 5 days of placebo, low-dose (4 × 10(9) colony forming units per day), or high-dose (8 × 10(9) colony forming units per day) probiotic (Lactobacillus helveticus and Lactobacillus rhamnosus) in a 2:1:1 ratio. The primary outcome was day care absenteeism.

RESULTS

The proportion of children missing a day of day care was 63% (39/62) and 61% (37/61) in the placebo and probiotic arms, respectively (95%CI -14.6% to 18.9%). The proportions experiencing unscheduled health care provider visits and intravenous fluid rehydration were 24% (15/62), 7% (4/62), and 30% (18/61), 5% (3/61) in the placebo and probiotic study arms, respectively (P = .52 and P = .65). None of the results differed based on probiotic dose.

CONCLUSIONS

The probiotic evaluated did not reduce absenteeism. Since power was suboptimal, further evaluation is required.

摘要

背景

对于因腹泻病前往急诊科就诊的儿童，给予益生菌治疗的益处尚不清楚。

方法

在这项三中心、双盲、安慰剂对照研究中，将4至48个月患有肠胃炎的儿童按2:1:1的比例随机分为接受5天安慰剂、低剂量（每天4×10⁹菌落形成单位）或高剂量（每天8×10⁹菌落形成单位）益生菌（瑞士乳杆菌和鼠李糖乳杆菌）治疗。主要结局是日托缺勤情况。

结果

安慰剂组和益生菌组中错过一天日托的儿童比例分别为63%（39/62）和61%（37/61）（95%CI -14.6%至18.9%）。安慰剂组和益生菌组中进行非计划的医疗服务提供者就诊和静脉补液的比例分别为24%（15/62）、7%（4/62）和30%（18/61）、5%（3/61）（P = 0.52和P = 0.65）。所有结果在益生菌剂量方面均无差异。