Abstract：
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.
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.
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.
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.
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.
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.
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：我们先前的菌株特异性系统评价（SR）表明，罗伊氏乳杆菌（LR）DSM17938可减少坏死性小肠结肠炎（NEC），迟发性败血症（LOS），和早产儿的完全喂养时间（TFF）。考虑到过去六年来该领域的进展，我们的目的是更新我们的SR。
方法：进行随机对照试验（RCTs）和非RCTs的SR。MEDLINE,EMBASE,EMCARE,2023年6月检索了CochraneCENTRAL和灰色文献数据库。
方法：TFF，NEC≥第二阶段,LOS,和全因死亡率。采用随机效应模型进行Meta分析。使用GRADE指南对证据确定性(CoE)进行了总结。试验序贯分析(TSA)用于RCT中NEC的结果。
结果：纳入了12个RCT（n=2284）和4个非RCT（n=1616）。其中,6个RCT和3个非RCT是新的.随机对照试验的荟萃分析显示，LR显著降低TFF[MD：-2.70(95%CI：-4.90至-1.31)天；p=0.0001)，NEC≥II期[RR：0.57（95％CI：0.37-0.87）；p=0.009，8个RCT）和LOS[RR：0.72（95％CI：0.54-0.97；p=0.03）。死亡率没有显着降低[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大小（DARIS）为3624。总体CoE：“非常低”。四个非随机对照试验的Meta分析显示，LR显著降低了NEC[OR：0.34（95%CI：0.15-0.77；p=0.01），但未降低LOS。LR无不良反应。
结论：非常低的CoE表明LRDSM17938可以降低NEC的风险，LOS,并缩短早产儿的TFF。需要额外的RCT来增加样本量和CoE。本文受版权保护。保留所有权利。
方法：进行随机对照试验（RCTs）和非RCTs的SR。MEDLINE,EMBASE,EMCARE,2023年6月检索了CochraneCENTRAL和灰色文献数据库。
方法：TFF，NEC≥第二阶段,LOS,和全因死亡率。采用随机效应模型进行Meta分析。使用GRADE指南对证据确定性(CoE)进行了总结。试验序贯分析(TSA)用于RCT中NEC的结果。
结果：纳入了12个RCT（n=2284）和4个非RCT（n=1616）。其中,6个RCT和3个非RCT是新的.随机对照试验的荟萃分析显示，LR显著降低TFF[MD：-2.70(95%CI：-4.90至-1.31)天；p=0.0001)，NEC≥II期[RR：0.57（95％CI：0.37-0.87）；p=0.009，8个RCT）和LOS[RR：0.72（95％CI：0.54-0.97；p=0.03）。死亡率没有显着降低[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大小（DARIS）为3624。总体CoE：“非常低”。四个非随机对照试验的Meta分析显示，LR显著降低了NEC[OR：0.34（95%CI：0.15-0.77；p=0.01），但未降低LOS。LR无不良反应。
结论：非常低的CoE表明LRDSM17938可以降低NEC的风险，LOS,并缩短早产儿的TFF。需要额外的RCT来增加样本量和CoE。本文受版权保护。保留所有权利。
