罗特氏乳杆菌 DSM 17938 作为早产儿益生菌：一项更新的系统评价和荟萃分析及试验序贯分析。

Limosilactobacillus reuteri DSM 17938 as a probiotic in preterm infants: An updated systematic review with meta-analysis and trial sequential analysis.

机构信息

Neonatal Directorate, King Edward Memorial Hospital for Women, Subiaco, Western Australia, Australia.

School of Medicine, University of Western Australia, Perth, Western Australia, Australia.

出版信息

JPEN J Parenter Enteral Nutr. 2023 Nov;47(8):963-981. doi: 10.1002/jpen.2564. Epub 2023 Oct 13.

DOI:10.1002/jpen.2564

PMID:37742098

Abstract

BACKGROUND: Our previous strain-specific systematic review (SR) showed that Lactobacillus reuteri (LR) DSM 17938 reduces necrotizing enterocolitis (NEC), late-onset sepsis (LOS), and time to full feeds (TFF) in preterm infants. Considering progress in the field over the past 6 years, we aimed to update our SR. METHODS: SR of randomized controlled trials (RCTs) and non-RCTs was conducted. MEDLINE, Embase, Emcare, Cochrane CENTRAL, and gray literature were searched in June 2023. Primary outcomes were TFF, NEC stage ≥II, LOS, and all-cause mortality. Meta-analysis was performed using random-effects model. Certainty of evidence (CoE) was summarized using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidelines. Trial sequential analysis (TSA) was applied for outcome of NEC in RCTs. RESULTS: Twelve RCTs (n = 2284) and four non-RCTs (n = 1616) were included. Six RCTs and three non-RCTs were new. Meta-analysis of RCTs showed LR significantly reduced TFF (mean difference, -2.70 [95% CI, -4.90 to -1.31] days; P = 0.0001), NEC stage ≥II (risk ratio [RR], 0.57 [95% CI, 0.37-0.87]; P = 0.009; eight RCTs), and LOS (RR, 0.72 [95% CI, 0.54-0.97]; P = 0.03); but not mortality (RR, 0.76 [95% CI, 0.54-1.06]; P = 0.10). TSA showed diversity-adjusted required information size (DARIS) as 3624 for NEC. Overall CoE was "very low." Meta-analysis of non-RCTs showed LR reduced NEC (odds ratio, 0.34 [95% CI, 0.15-0.77]; P = 0.01) but not LOS. LR had no adverse effects. CONCLUSIONS: Very low CoE suggests that LR DSM 17938 may reduce NEC and LOS and shorten TFF in preterm infants. Additional RCTs are required to confirm our findings.

摘要

背景：我们之前的针对特定菌株的系统评价（SR）表明，罗伊氏乳杆菌（LR）DSM 17938 可降低早产儿坏死性小肠结肠炎（NEC）、晚发性败血症（LOS）和完全喂养时间（TFF）。考虑到过去 6 年该领域的进展，我们旨在更新我们的 SR。

方法：对随机对照试验（RCT）和非 RCT 进行了 SR。2023 年 6 月，检索了 MEDLINE、Embase、Emcare、Cochrane 中心数据库和灰色文献。主要结局为 TFF、NEC 分期≥Ⅱ、LOS 和全因死亡率。使用随机效应模型进行荟萃分析。使用推荐评估、制定与评价（GRADE）指南总结证据确定性（CoE）。对 RCT 中 NEC 的结局进行了试验序贯分析（TSA）。

结果：纳入了 12 项 RCT（n=2284）和 4 项非 RCT（n=1616）。其中 6 项 RCT 和 3 项非 RCT 为新研究。RCT 的荟萃分析显示，LR 显著缩短 TFF（平均差，-2.70[95%CI，-4.90 至-1.31]天；P=0.0001）、NEC 分期≥Ⅱ（风险比 [RR]，0.57[95%CI，0.37-0.87]；P=0.009；8 项 RCT）和 LOS（RR，0.72[95%CI，0.54-0.97]；P=0.03），但不影响死亡率（RR，0.76[95%CI，0.54-1.06]；P=0.10）。TSA 显示，NEC 的多样性调整所需信息量（DARIS）为 3624。总体 CoE 为“极低”。非 RCT 的荟萃分析显示，LR 降低了 NEC（比值比，0.34[95%CI，0.15-0.77]；P=0.01），但不影响 LOS。LR 无不良影响。

结论：极低的 CoE 表明，LR DSM 17938 可能降低早产儿 NEC 和 LOS 的发生率并缩短 TFF。需要进一步的 RCT 来证实我们的发现。