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共生元预防和治疗特应性皮炎的效果:一项随机临床试验的荟萃分析。

Synbiotics for Prevention and Treatment of Atopic Dermatitis: A Meta-analysis of Randomized Clinical Trials.

机构信息

Department of Pediatrics, Taipei City Hospital Renai Branch and National Yang-Ming University, Taipei, Taiwan.

Massachusetts General Hospital for Children, Boston3Channing Division of Network Science, Brigham and Women's Hospital, Boston, Massachusetts.

出版信息

JAMA Pediatr. 2016 Mar;170(3):236-42. doi: 10.1001/jamapediatrics.2015.3943.

Abstract

IMPORTANCE

Atopic dermatitis (AD) is a highly prevalent condition that may be associated with an altered gastrointestinal microbiota that promotes an immune environment more susceptible to allergic disease. Synbiotics, a mixture of prebiotics and probiotics, have been used for the prevention and treatment of AD.

OBJECTIVE

To investigate the efficacy of synbiotics for primary prevention and treatment of AD.

DATA SOURCES

PubMed/MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and the CAB Abstracts Archive searchable database were searched from the inception of all databases to October 15, 2015, with no language restrictions.

STUDY SELECTION

We included all published randomized clinical trials of synbiotics for prevention and/or treatment of AD. To be included, a publication needed to clearly define the intervention as oral administration of synbiotics (combination of probiotics and prebiotics) and must have included an assessment of AD disease severity, such as the Severity Scoring of Atopic Dermatitis (SCORAD) index, or the incidence of AD as an outcome measure. Only 8 of 257 initially identified studies (3%) met selection criteria.

DATA EXTRACTION AND SYNTHESIS

Data extraction was independently done by multiple observers and cross-checked to avoid errors. The quality of the selected studies was critically examined following the Cochrane guidelines. Data were pooled using a random-effects model.

MAIN OUTCOMES AND MEASURES

The primary outcomes were the SCORAD index (treatment studies) and the relative risk of AD (prevention studies). The hypothesis was formulated before data collection.

RESULTS

A total of 257 abstracts were screened to identify 6 treatment studies (369 children enrolled; aged 0 months to 14 years) and 2 prevention studies (1320 children enrolled; up to age 6 months in one study and term neonates aged <3 days in the other). From the 6 treatment studies included for random-effects meta-analysis, the overall pooled change in SCORAD index in those treated with synbiotics at 8 weeks of treatment was -6.56 (95% CI, -11.43 to -1.68; P = .008). Heterogeneity was significant (I(2) = 77.1%; P = .001). Subgroup analysis showed that the beneficial effect was significant only when using mixed strains of bacteria (weighted mean difference, -7.32; 95% CI, -13.98 to -0.66; P = .03) and when used in children aged 1 year or older (weighted mean difference, -7.37; 95% CI, -14.66 to -0.07; P = .048). From the 2 prevention studies included, the pooled relative risk ratio of AD in those treated with synbiotics compared with placebo was 0.44 (95% CI, 0.11 to 1.83; P = .26).

CONCLUSIONS AND RELEVANCE

This meta-analysis shows evidence that supports the use of synbiotics for the treatment of AD, particularly synbiotics with mixed strains of bacteria and for children aged 1 year or older. Further studies are needed to evaluate the effectiveness of synbiotics for primary prevention of AD.

摘要

重要性

特应性皮炎(AD)是一种高度流行的疾病,可能与促进更易患过敏性疾病的免疫环境的改变的胃肠道微生物群有关。益生菌与益生元的混合物——合生素,已被用于 AD 的预防和治疗。

目的

研究合生素对 AD 的一级预防和治疗的疗效。

数据来源

从所有数据库的创建到 2015 年 10 月 15 日,对 PubMed/MEDLINE、EMBASE、Cochrane 对照试验中心注册库和 CAB Abstracts Archive 可搜索数据库进行了检索,没有语言限制。

研究选择

我们纳入了所有关于合生素预防和/或治疗 AD 的已发表的随机临床试验。为了纳入研究,出版物必须明确将干预措施定义为合生素(益生菌和益生元的组合)的口服给药,并且必须包括 AD 疾病严重程度的评估,例如特应性皮炎严重程度评分(SCORAD)指数,或 AD 的发病率作为衡量结果。最初确定的 257 项研究中只有 8 项(3%)符合选择标准。

数据提取和综合

数据提取由多名观察者独立进行,并进行交叉核对以避免错误。根据 Cochrane 指南,批判性地检查了选定研究的质量。使用随机效应模型对数据进行了汇总。

主要结果和测量

主要结果是 SCORAD 指数(治疗研究)和 AD 的相对风险(预防研究)。假设在数据收集之前就已经提出。

结果

共筛选了 257 份摘要,以确定 6 项治疗研究(369 名儿童入组;年龄 0 个月至 14 岁)和 2 项预防研究(1320 名儿童入组;一项研究中为 6 个月以下,另一项研究中为胎龄 <3 天的新生儿)。从纳入的 6 项治疗研究中进行随机效应荟萃分析,接受合生素治疗的患者在 8 周治疗时 SCORAD 指数的总体平均变化为 -6.56(95%CI,-11.43 至 -1.68;P =.008)。异质性显著(I(2) = 77.1%;P =.001)。亚组分析表明,只有当使用混合细菌株时,有益效果才具有统计学意义(加权平均差异,-7.32;95%CI,-13.98 至 -0.66;P =.03),并且当用于 1 岁或以上的儿童时(加权平均差异,-7.37;95%CI,-14.66 至 -0.07;P =.048)。从纳入的 2 项预防研究来看,与安慰剂相比,接受合生素治疗的患者发生 AD 的相对风险比为 0.44(95%CI,0.11 至 1.83;P =.26)。

结论和相关性

这项荟萃分析表明,有证据支持合生素用于治疗 AD,特别是用于治疗年龄在 1 岁或以上的儿童的混合细菌株合生素。需要进一步研究来评估合生素预防 AD 的有效性。

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