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补充益生菌对重症患者感染性和胃肠道并发症的影响:随机、双盲、安慰剂对照临床试验。

Effects of probiotic supplementation on infectious and gastrointestinal complications of critically ill patients: Randomized, blinded, placebo-controlled clinical trial.

作者信息

Naslowski Janaina Bach, Schieferdecker Maria Eliana Madalozzo, Campos Antonio Carlos Ligocki

机构信息

Postgraduate Program in Food and Nutrition, Department of Nutrition, Federal University of Parana (UFPR), Curitiba, Paraná, Brazil.

Professor of Postgraduate Program in Food and Nutrition, Department of Nutrition, Federal University of Parana (UFPR), Curitiba, Paraná, Brazil.

出版信息

Clin Nutr ESPEN. 2025 Aug;68:228-237. doi: 10.1016/j.clnesp.2025.05.006. Epub 2025 May 7.

DOI:10.1016/j.clnesp.2025.05.006
PMID:40345657
Abstract

BACKGROUND

Critically ill patients frequently experience alterations in gut microbiota, known as dysbiosis, which has been associated with unfavorable clinical outcomes. The use of probiotics is one approach to modulating gut microbiota.

OBJECTIVE

This study aimed to evaluate the effects of probiotic supplementation combined with enteral nutrition (EN) in critically ill patients on infectious, gastrointestinal complications, and clinical outcomes.

METHODS

This is a randomized, blinded, placebo-controlled clinical trial conducted with 70 individuals aged ≥18 years, receiving enteral nutrition, and admitted to the emergency intensive care unit (ICU) of a tertiary hospital. The intervention consisted of Lactobacillus paracasei SD 5275, Lactobacillus rhamnosus SD 5675, Lactobacillus acidophilus SD 5221, and Bifidobacterium lactis SD 5674 (10 Colony Forming Units (CFU) of each bacterium/sachet, two sachets per day were used), administered via EN once daily for at least 5 days until ICU discharge, death, or initiation of an oral diet. The primary outcomes were the occurrence of infections and gastrointestinal symptoms. Secondary outcomes included the use of antibiotics, laxatives, prokinetics, duration of mechanical ventilation (MV), ICU stay, and mortality.

RESULTS

There was no significant difference in the occurrence of any type of infection or gastrointestinal symptoms between the groups (p ≥ 0.05). The use of antibiotics and laxatives was similar between the groups (p = 1.000 and 0.917, respectively). The average duration of prokinetic use was shorter in the intervention group (2.80 ± 1.52 vs. 6.08 ± 5.58 days, 95 % Confidence interval (CI) -1.39; -0.0594, p = 0.011). Although the number of days on mechanical ventilation, ICU stay, and mortality were lower in the patients who received probiotics, no significant differences were observed between the groups (p ≥ 0.05).

CONCLUSION

It is concluded that ICU patients supplemented with probiotics have a shorter duration of prokinetic use. However, supplementation does not directly impact gastrointestinal symptoms, infections, antibiotic use, laxative use, duration of mechanical ventilation, ICU stay, or mortality.

REGISTERED AT

Brazilian Clinical Trials Registry (ReBEC) under the number: ID RBR-2kqnj2t. SITE: https://ensaiosclinicos.gov.br/welcome.

摘要

背景

重症患者常出现肠道微生物群改变,即生态失调,这与不良临床结局相关。使用益生菌是调节肠道微生物群的一种方法。

目的

本研究旨在评估补充益生菌联合肠内营养(EN)对重症患者感染、胃肠道并发症及临床结局的影响。

方法

这是一项随机、双盲、安慰剂对照临床试验,纳入70名年龄≥18岁、接受肠内营养并入住一家三级医院急诊重症监护病房(ICU)的患者。干预措施为副干酪乳杆菌SD 5275、鼠李糖乳杆菌SD 5675、嗜酸乳杆菌SD 5221和双歧双歧杆菌SD 5674(每袋每种细菌10个菌落形成单位(CFU),每天使用两袋),通过肠内营养每日给药一次,至少持续5天,直至患者转出ICU、死亡或开始口服饮食。主要结局为感染和胃肠道症状的发生情况。次要结局包括抗生素、泻药、促动力药的使用情况,机械通气(MV)时间、ICU住院时间及死亡率。

结果

两组间任何类型感染或胃肠道症状的发生率均无显著差异(p≥0.05)。两组间抗生素和泻药的使用情况相似(p分别为1.000和0.917)。干预组促动力药的平均使用时间较短(2.80±1.52天对6.08±5.58天,95%置信区间(CI)-1.39;-0.0594,p=0.011)。尽管接受益生菌治疗的患者机械通气天数、ICU住院时间和死亡率较低,但两组间无显著差异(p≥0.05)。

结论

得出结论,补充益生菌的ICU患者促动力药使用时间较短。然而,补充益生菌并不直接影响胃肠道症状、感染、抗生素使用、泻药使用、机械通气时间、ICU住院时间或死亡率。

注册信息

巴西临床试验注册中心(ReBEC),注册号:ID RBR-2kqnj2t。网站:https://ensaiosclinicos.gov.br/welcome。

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