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益生菌酸奶预防成人抗生素相关性腹泻的随机双盲安慰剂对照试验。

Probiotic Yogurt for the Prevention of Antibiotic-associated Diarrhea in Adults: A Randomized Double-blind Placebo-controlled Trial.

机构信息

Infectious Diseases Section, Internal Medicine.

Department of Biotechnology and Food Microbiology, Institute of Food Science Research CIAL, Consejo Superior de Investigaciones Científicas CSIC, Madrid, Spain.

出版信息

J Clin Gastroenterol. 2019 Nov/Dec;53(10):717-723. doi: 10.1097/MCG.0000000000001131.

Abstract

GOAL

To evaluate the effect of yogurt supplemented with probiotic bacteria on the prevention of antibiotic-associated diarrhea (AAD) in hospitalized patients.

BACKGROUND

Diarrhea following antibiotic administration is a frequent clinical problem. The usefulness of probiotics for the prevention of AAD in the hospitalized adult population remains unclear.

STUDY

A randomized, double-blind, placebo-controlled clinical trial was conducted in hospitalized patients who started antibiotic treatment. Patients were randomized (2:2:1) to receive a daily amount of 200 mL of placebo-yogurt (Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus), 200 mL of probiotic yogurt (previous plus Lactobacillus acidophilus La-5, Bifidobacterium animalis subsp. lactis Bb-12 and Lactobacillus casei subsp. casei Lc-01 or no yogurt (unblinded control) within 48 hours of beginning the antibiotic therapy and up to 5 days after stopping the antibiotic. Patients were followed up with for 1 month to determine occurrence of diarrhea.

RESULTS

We included 314 patients, mean age 76 years. The rate of diarrhea was 23.0% in the probiotic group versus 17.6% in the placebo group, absolute risk reduction -5.35% (95% confidence interval, -15.4% to 4.7%; P=0.30). Rate of diarrhea was similar in the unblinded external control and in the blinded study groups combined (20.9% vs. 20.2% respectively; P=0.91). There was no difference in the duration of diarrhea, maximum number of bowel movements or prolonged admission because of diarrhea among the groups. All-cause mortality did not differ between groups.

CONCLUSIONS

The combined probiotic strains LA-5, BB-12, and LC-01 do not have an effect in the prevention of AAD in hospitalized patients.

摘要

目的

评估益生菌酸奶对预防住院患者抗生素相关性腹泻(AAD)的效果。

背景

抗生素治疗后出现腹泻是一种常见的临床问题。益生菌预防住院成年人群 AAD 的效果尚不清楚。

研究

一项随机、双盲、安慰剂对照的临床试验在开始接受抗生素治疗的住院患者中进行。患者随机(2:2:1)接受每天 200 毫升安慰剂酸奶(嗜热链球菌和德氏乳杆菌保加利亚亚种)、200 毫升益生菌酸奶(前两者加嗜酸乳杆菌 La-5、动物双歧杆菌亚种 Bb-12 和干酪乳杆菌亚种 Lc-01)或无酸奶(未设盲对照),在开始抗生素治疗的 48 小时内和停止抗生素后 5 天内给予酸奶。患者接受随访 1 个月以确定腹泻的发生情况。

结果

我们纳入了 314 名患者,平均年龄 76 岁。益生菌组腹泻发生率为 23.0%,安慰剂组为 17.6%,绝对风险降低 5.35%(95%置信区间,-15.4%至 4.7%;P=0.30)。未设盲外部对照和设盲研究组的腹泻发生率相似(分别为 20.9%和 20.2%;P=0.91)。各组间腹泻持续时间、最大排便次数或因腹泻而延长住院时间均无差异。各组间全因死亡率无差异。

结论

联合益生菌株 LA-5、BB-12 和 LC-01 对预防住院患者 AAD 无效。

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