鼠李糖乳杆菌 GG 对比安慰剂治疗儿童急性肠胃炎。

Lactobacillus rhamnosus GG versus Placebo for Acute Gastroenteritis in Children.

机构信息

From the Divisions of Pediatric Emergency Medicine (D.S., V.P.D.) and Gastroenterology, Hepatology, and Nutrition (P.I.T., C.H.-M.), Department of Pediatrics, Washington University School of Medicine, St. Louis; the Department of Pediatrics, University of Utah, Salt Lake City (T.C.C., J.M.D., C.S.O., M.M.); Central Administration, Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis (M.H.G.); the Division of Emergency Medicine, Children's National Health System, Department of Pediatrics, George Washington School of Medicine and Health Sciences, Washington, DC (K.J.O.); the Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Michigan, Wayne State University, Detroit (P.M.); the Departments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor (P.M., A.J.R.); the Department of Emergency Medicine, Rhode Island Hospital/Hasbro Children's Hospital and Brown University, Providence (A.C.L.); the Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati (D.S., S.R.B.); the Division of Emergency Medicine, Department of Pediatrics, Columbia University College of Physicians and Surgeons, New York (C.G.R.); the Division of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago (E.C.P.); the Departments of Emergency Medicine and Pediatrics, University of California Davis School of Medicine, Sacramento (C.V.); the Department of Emergency Medicine, University of New Mexico, Albuquerque (R.E.S.); and the Sections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada (S.B.F.).

出版信息

N Engl J Med. 2018 Nov 22;379(21):2002-2014. doi: 10.1056/NEJMoa1802598.

DOI:10.1056/NEJMoa1802598

PMID:30462938

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6358014/

Abstract

BACKGROUND

Acute gastroenteritis develops in millions of children in the United States every year, and treatment with probiotics is common. However, data to support the use of probiotics in this population are limited.

METHODS

We conducted a prospective, randomized, double-blind trial involving children 3 months to 4 years of age with acute gastroenteritis who presented to one of 10 U.S. pediatric emergency departments. Participants received a 5-day course of Lactobacillus rhamnosus GG at a dose of 1×10 colony-forming units twice daily or matching placebo. Follow-up surveys were conducted daily for 5 days and again 14 days after enrollment and 1 month after enrollment. The primary outcome was moderate-to-severe gastroenteritis, which was defined as an illness episode with a total score on the modified Vesikari scale of 9 or higher (scores range from 0 to 20, with higher scores indicating more severe disease), within 14 days after enrollment. Secondary outcomes included the duration and frequency of diarrhea and vomiting, the duration of day-care absenteeism, and the rate of household transmission (defined as the development of symptoms of gastroenteritis in previously asymptomatic household contacts).

RESULTS

Among the 971 participants, 943 (97.1%) completed the trial. The median age was 1.4 years (interquartile range, 0.9 to 2.3), and 513 participants (52.9%) were male. The modified Vesikari scale score for the 14-day period after enrollment was 9 or higher in 55 of 468 participants (11.8%) in the L. rhamnosus GG group and in 60 of 475 participants (12.6%) in the placebo group (relative risk, 0.96; 95% confidence interval, 0.68 to 1.35; P=0.83). There were no significant differences between the L. rhamnosus GG group and the placebo group in the duration of diarrhea (median, 49.7 hours in the L. rhamnosus GG group and 50.9 hours in the placebo group; P=0.26), duration of vomiting (median, 0 hours in both groups; P=0.17), or day-care absenteeism (median, 2 days in both groups; P=0.67) or in the rate of household transmission (10.6% and 14.1% in the two groups, respectively; P=0.16).

CONCLUSIONS

Among preschool children with acute gastroenteritis, those who received a 5-day course of L. rhamnosus GG did not have better outcomes than those who received placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT01773967 .).

摘要

背景

每年有上百万美国儿童患急性肠胃炎，使用益生菌治疗较为常见。然而，支持该人群使用益生菌的数据有限。

方法

我们开展了一项前瞻性、随机、双盲试验，纳入在美国 10 家儿科急诊就诊的 3 个月至 4 岁患有急性肠胃炎的儿童。参与者接受为期 5 天的鼠李糖乳杆菌 GG 治疗，剂量为 1×10 菌落形成单位，每日 2 次，或匹配的安慰剂。在入组后 5 天和 14 天以及入组后 1 个月每天进行随访调查。主要结局为中重度肠胃炎，定义为改良 Vesikari 量表评分在 9 分或更高（评分范围为 0 至 20 分，评分越高表示疾病越严重），在入组后 14 天内出现的疾病发作。次要结局包括腹泻和呕吐的持续时间和频率、日托缺勤天数以及家庭传播率（定义为以前无症状的家庭接触者出现肠胃炎症状）。

结果

在 971 名参与者中，943 名（97.1%）完成了试验。中位年龄为 1.4 岁（四分位间距，0.9 至 2.3），513 名参与者（52.9%）为男性。在入组后 14 天期间，L. rhamnosus GG 组有 55 名（11.8%）参与者的改良 Vesikari 量表评分等于或高于 9 分，安慰剂组有 60 名（12.6%）参与者的评分等于或高于 9 分（比值比，0.96；95%置信区间，0.68 至 1.35；P=0.83）。L. rhamnosus GG 组与安慰剂组在腹泻持续时间（L. rhamnosus GG 组的中位数为 49.7 小时，安慰剂组为 50.9 小时；P=0.26）、呕吐持续时间（两组均为 0 小时；P=0.17）或日托缺勤天数（两组均为 2 天；P=0.67）方面，或家庭传播率（两组分别为 10.6%和 14.1%；P=0.16）方面均无显著差异。