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益生菌预防急性上呼吸道感染。

Probiotics for preventing acute upper respiratory tract infections.

机构信息

National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, China.

The Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, Chengdu, China.

出版信息

Cochrane Database Syst Rev. 2022 Aug 24;8(8):CD006895. doi: 10.1002/14651858.CD006895.pub4.

Abstract

BACKGROUND

Probiotics are live micro-organisms that may give a beneficial physiological effect when administered in adequate amounts. Some trials show that probiotic strains can prevent respiratory infections. Even though our previously published review showed the benefits of probiotics for acute upper respiratory tract infections (URTIs), several new studies have been published. This is an update of a review first published in 2011 and updated in 2015.

OBJECTIVES

To assess the effectiveness and safety of probiotics (any specified strain or dose), compared with placebo or no treatment, in the prevention of acute URTIs in people of all ages, at risk of acute URTIs.

SEARCH METHODS

We searched CENTRAL (2022, Issue 6), MEDLINE (1950 to May week 2, 2022), Embase (1974 to 10 May 2022), Web of Science (1900 to 10 May 2022), the Chinese Biomedical Literature Database, which includes the China Biological Medicine Database (from 1978 to 10 May 2022), the Chinese Medicine Popular Science Literature Database (from 2000 to 10 May 2022), and the Master's Degree Dissertation of Beijing Union Medical College Database (from 1981 to 10 May 2022). We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov for completed and ongoing trials on 10 May 2022.

SELECTION CRITERIA

We included individual randomised controlled trials (RCTs) and cluster-RCTs comparing probiotics with placebo or no treatment to prevent acute URTIs. The participants were children, adults, or the elderly in the community, care facilities, schools, or hospitals. Our main outcomes were the number of participants diagnosed with URTIs (at least one event and at least three events), the incidence rate (number of cases/person year) of acute URTIs, and the mean duration of an episode of URTIs. Our secondary outcomes were the number of participants who were absent from childcare centre, school, or work due to acute URTIs; the number of participants who used prescribed antibiotics for acute URTIs; and the number of participants who experienced at least one adverse event from probiotics. We excluded studies if they did not specify acute respiratory infections as 'upper'; studies with more than 50% of participants vaccinated against influenza or other acute URTIs within the last 12 months; and studies with significantly different proportions of vaccinated participants between the probiotics arm and the placebo or no treatment arm.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed the eligibility of trials and extracted data using standard Cochrane methodological procedures. We analysed both intention-to-treat and per-protocol data and used a random-effects model. We expressed results as risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, both with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE approach.

MAIN RESULTS

We included 23 individual RCTs and one cluster-RCT. As one of the individual RCTs did not report outcomes in a usable way, we could only meta-analyse data from 23 trials, involving a total of 6950 participants including children (aged from one month to 11 years old), adults (mean age 37.3), and older people (mean age 84.6 years). One trial reported 22.5% flu-vaccine participants within the last 12 months, and 25.4% flu-vaccine participants during the intervention. Probiotics were more likely to be given with milk-based food in children; administered in powder form in adults; and given with milk-based food or in capsules in the elderly. Most of the studies used one or two strains (e.g. Lactobacillus plantarum HEAL9, Lactobacillus paracasei (8700:2 or N1115)) and 10 or 10 colony-forming units (CFU)/day of probiotics for more than three months. We found that probiotics may reduce the number of participants diagnosed with URTIs (at least one event) (RR 0.76, 95% CI 0.67 to 0.87; P < 0.001; 16 studies, 4798 participants; low-certainty evidence); likely reduce the number of participants diagnosed with URTIs (at least three events) (RR 0.59, 95% CI 0.38 to 0.91; P = 0.02; 4 studies, 763 participants; moderate-certainty evidence); may reduce the incidence rate (number of cases/person year) of URTIs (rate ratio 0.82, 95% CI 0.73 to 0.92, P = 0.001; 12 studies, 4364 participants; low-certainty evidence); may reduce the mean duration of an episode of acute URTIs (MD -1.22 days, 95% CI -2.12 to -0.33; P = 0.007; 6 studies, 2406 participants; low-certainty evidence); likely reduce the number of participants who used prescribed antibiotics for acute URTIs (RR 0.58, 95% CI 0.42 to 0.81; P = 0.001; 6 studies, 1548 participants; moderate-certainty evidence); and may not increase the number of participants who experienced at least one adverse event (RR 1.02, 95% CI 0.90 to 1.15; P = 0.79; 8 studies, 2456 participants; low-certainty evidence). Evidence showing a decrease in the number of people absent from childcare centre, school, or work due to acute URTIs with probiotics is very uncertain (RR 0.14, 95% CI 0.03 to 0.59; 1 study, 80 participants; very low-certainty evidence). Adverse events from probiotics were minor, and most commonly gastrointestinal symptoms, such as vomiting, flatulence, diarrhoea, and bowel pain.  AUTHORS' CONCLUSIONS: Overall, we found that probiotics were better than placebo or no treatment in preventing acute URTIs.

摘要

背景

益生菌是活的微生物,当以足够的剂量给予时,可能会产生有益的生理效应。一些试验表明益生菌菌株可以预防呼吸道感染。尽管我们之前发表的综述显示益生菌对急性上呼吸道感染(URTIs)有好处,但已经发表了几项新的研究。这是对 2011 年首次发表的综述的更新,并于 2015 年进行了更新。

目的

评估益生菌(任何特定菌株或剂量)与安慰剂或无治疗相比,在预防所有年龄段、有急性 URTIs 风险的人群中急性 URTIs 的有效性和安全性。

检索方法

我们检索了 CENTRAL(2022 年第 6 期)、MEDLINE(1950 年至 2022 年 5 月第 2 周)、Embase(1974 年至 2022 年 5 月 10 日)、Web of Science(1900 年至 2022 年 5 月 10 日)、中国生物医学文献数据库,其中包括中国生物医学数据库(1978 年至 2022 年 5 月 10 日)、中国中医药科普文献数据库(2000 年至 2022 年 5 月 10 日)和北京协和医学院研究生论文数据库(1981 年至 2022 年 5 月 10 日)。我们还于 2022 年 5 月 10 日在世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov 上搜索了正在进行和已完成的试验。

入选标准

我们纳入了比较益生菌与安慰剂或无治疗预防急性 URTIs 的随机对照试验(RCTs)和整群随机对照试验。参与者为社区、护理机构、学校或医院的儿童、成人或老年人。我们的主要结局是诊断为 URTIs 的参与者人数(至少一次事件和至少三次事件)、急性 URTIs 的发病率(每例/人年的病例数)和急性 URTIs 发作的平均持续时间。我们的次要结局是因急性 URTIs 而缺勤的儿童保育中心、学校或工作的参与者人数;因急性 URTIs 而使用处方抗生素的参与者人数;以及经历至少一次益生菌不良反应的参与者人数。如果研究没有将急性呼吸道感染指定为“上呼吸道”;在过去 12 个月内有超过 50%的参与者接种流感或其他急性 URTIs 疫苗;并且益生菌组和安慰剂或无治疗组之间的疫苗接种参与者比例明显不同,则我们将排除这些研究。

数据收集和分析

两名综述作者独立评估试验的纳入标准,并使用标准的 Cochrane 方法学程序提取数据。我们对意向治疗和符合方案数据进行了分析,并使用了随机效应模型。我们以风险比(RR)表示二分类结局,以均数差(MD)表示连续性结局,置信区间(CI)均为 95%。我们使用 GRADE 方法评估证据的确定性。

主要结果

我们纳入了 23 项单独的 RCT 和一项整群 RCT。由于其中一项 RCT 未以可用的方式报告结局,因此我们只能对来自 23 项试验的数据进行荟萃分析,这些试验共涉及 6950 名参与者,包括儿童(年龄从一个月到 11 岁)、成年人(平均年龄 37.3 岁)和老年人(平均年龄 84.6 岁)。一项试验报告在过去 12 个月内有 22.5%的流感疫苗接种者,在干预期间有 25.4%的流感疫苗接种者。益生菌更可能与儿童食用的牛奶基食品一起给予;在成年人中以粉末形式给予;在老年人中与牛奶基食品或胶囊一起给予。大多数研究使用一种或两种菌株(例如植物乳杆菌 HEAL9、副干酪乳杆菌(8700:2 或 N1115)),每天给予 10 或 10 菌落形成单位(CFU)的益生菌超过三个月。我们发现益生菌可能减少诊断为 URTIs(至少一次事件)的参与者人数(RR 0.76,95%CI 0.67 至 0.87;P<0.001;16 项研究,4798 名参与者;低质量证据);可能减少诊断为 URTIs(至少三次事件)的参与者人数(RR 0.59,95%CI 0.38 至 0.91;P=0.02;4 项研究,763 名参与者;中等质量证据);可能减少 URTIs 的发病率(每例/人年的病例数)(比率比 0.82,95%CI 0.73 至 0.92,P=0.001;12 项研究,4364 名参与者;低质量证据);可能减少急性 URTIs 发作的平均持续时间(MD-1.22 天,95%CI-2.12 至-0.33;P=0.007;6 项研究,2406 名参与者;低质量证据);可能减少因急性 URTIs 而使用处方抗生素的参与者人数(RR 0.58,95%CI 0.42 至 0.81;P=0.001;6 项研究,1548 名参与者;中等质量证据);并且可能不会增加经历至少一次益生菌不良反应的参与者人数(RR 1.02,95%CI 0.90 至 1.15;P=0.79;8 项研究,2456 名参与者;低质量证据)。益生菌可减少因急性 URTIs 缺勤的儿童保育中心、学校或工作人数的证据非常不确定(RR 0.14,95%CI 0.03 至 0.59;1 项研究,80 名参与者;极低质量证据)。益生菌的不良反应轻微,最常见的是胃肠道症状,如呕吐、腹胀、腹泻和腹痛。

作者结论

总体而言,我们发现益生菌在预防急性 URTIs 方面优于安慰剂或无治疗。

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