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中国国家微生物资源库I-745治疗小儿急性腹泻的疗效和安全性:一项系统评价与Meta分析

Efficacy and safety of CNCM I-745 for the treatment of pediatric acute diarrhea in China: a systematic review and meta-analysis.

作者信息

McFarland Lynne V, Li Tong

机构信息

McFarland Consulting, Seattle, WA, United States.

Public Health Reserves Corps, Seattle, WA, United States.

出版信息

Front Cell Infect Microbiol. 2025 Jun 4;15:1587792. doi: 10.3389/fcimb.2025.1587792. eCollection 2025.

DOI:10.3389/fcimb.2025.1587792
PMID:40535538
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12174131/
Abstract

BACKGROUND

Pediatric acute gastroenteritis (PAGE) is a common cause of morbidity and mortality, especially in children under five years old. Therapeutic strategies including probiotics have been investigated, but trials from non-English speaking countries may not be easily accessible.

AIM

To determine the efficacy of compared to controls for treating PAGE in children receiving standard rehydration therapy in trials conducted in China.

METHODS

Systematic review and meta-analysis using literature search with Google Scholar, PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure and China Biology Medicine disc (from inception to June 30, 2024) of randomized, controlled trials comparing CNCM I-745 to controls for the treatment of PAGE in children conducted in China. Independent data extraction by two reviewers. Standard meta-analysis methods were applied and random-effect or fixed-effects models were used depending upon the degree of heterogeneity using standardized mean differences for continuous data and relative risk estimates for dichotomous outcomes. The risk of bias for each study was determined and heterogeneity was measured by I.

RESULTS

Of 851 articles screened, 10 RCTs (1125 participants) met the inclusion criteria, and none were found in non-Chinese databases. CNCM I-745 was found to significantly reduce the duration of PAGE (SMD=-1.63 days, 95% CI -2.08, -1.18), improve the total effectiveness rating (RR=1.22, 95% CI 1.16, 1.28) and significantly more participants were cured (RR=1.47, 95% CI 1.30, 1.67). The finding that significantly reduced the levels of two pro-inflammatory cytokines (TNF-α and IL8) has not been reported in previous meta-analyses of PAGE.

CONCLUSION

CNCM I-745 is an effective treatment for PAGE and was well tolerated in trials done in China.

SYSTEMATIC REVIEW REGISTRATION

www.crd.york.ac.uk/PRSPERO, identifier CRD 42024567537.

摘要

背景

小儿急性肠胃炎(PAGE)是发病和死亡的常见原因,尤其是在五岁以下儿童中。包括益生菌在内的治疗策略已得到研究,但来自非英语国家的试验可能不易获取。

目的

在中国进行的试验中,确定与对照组相比,[具体药物或治疗方法未给出,用“”代替] 对接受标准补液治疗的儿童治疗PAGE的疗效。

方法

通过使用谷歌学术、PubMed、Embase、Cochrane图书馆、中国知网和中国生物医学光盘(从创刊到2024年6月30日)进行文献检索,对在中国进行的比较[具体药物或治疗方法未给出,用“”代替] (CNCM I - 745)与对照组治疗儿童PAGE的随机对照试验进行系统评价和荟萃分析。由两名 reviewers 独立进行数据提取。应用标准荟萃分析方法,根据异质性程度使用连续数据的标准化均数差和二分结果的相对风险估计值,采用随机效应或固定效应模型。确定每项研究的偏倚风险,并通过I²测量异质性。

结果

在筛选的851篇文章中,10项随机对照试验(1125名参与者)符合纳入标准,在非中文数据库中未发现相关研究。发现[具体药物或治疗方法未给出,用“”代替] (CNCM I - 745)可显著缩短PAGE病程(标准化均数差=-1.63天,95%置信区间 -2.08,-1.18),提高总有效率(相对风险=1.22,95%置信区间1.16,1.28),且治愈的参与者显著更多(相对风险=1.47,95%置信区间1.30,1.67)。[具体药物或治疗方法未给出,用“”代替] 显著降低两种促炎细胞因子(TNF-α和IL8)水平这一发现,在先前关于PAGE的荟萃分析中尚未报道。

结论

[具体药物或治疗方法未给出,用“”代替] (CNCM I - 745)是治疗PAGE的有效方法,在中国进行的试验中耐受性良好。

系统评价注册

www.crd.york.ac.uk/PRSPERO,标识符CRD 42024567537。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/634b/12174131/1ffde52b2622/fcimb-15-1587792-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/634b/12174131/659542e181ad/fcimb-15-1587792-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/634b/12174131/31d70cce6988/fcimb-15-1587792-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/634b/12174131/01f0c0253251/fcimb-15-1587792-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/634b/12174131/1ffde52b2622/fcimb-15-1587792-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/634b/12174131/659542e181ad/fcimb-15-1587792-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/634b/12174131/31d70cce6988/fcimb-15-1587792-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/634b/12174131/01f0c0253251/fcimb-15-1587792-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/634b/12174131/1ffde52b2622/fcimb-15-1587792-g004.jpg

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