Human Milk-Derived Versus Bovine Protein-Based Fortifiers for Preterm Infants Fed Human Milk: A Systematic Review and Meta-Analysis.
完整摘要 · 中文译文
背景：人乳来源强化剂（HumBMF）是早产儿牛乳蛋白强化剂（BovBMF）的替代选择，但其相对有效性和安全性仍不确定。我们评估了HumBMF与BovBMF在早产儿或极低出生体重儿中的效果。方法：通过四个数据库和三个试验注册库（截至2026年5月11日）检索比较使用HumBMF与BovBMF强化人乳的随机对照试验（RCT）。至少两名评价者独立筛选研究、提取数据并评估偏倚风险。进行了固定效应荟萃分析和GRADE评价。预设分析将仅比较强化剂类型的试验（其中任何母亲自身母乳（MOM）不足在两臂均以捐赠人乳（DHM）补充）与双重干预试验（其中MOM不足在HumBMF臂还随机分配至DHM或在BovBMF臂随机分配至早产儿配方奶）分开。结果：共纳入九项RCT。在仅比较强化剂类型的试验中，没有证据表明HumBMF降低死亡率（RR 0.60（95% CI 0.29-1.23），低确定性）或坏死性小肠结肠炎（NEC；RR 0.83（0.39-1.78），极低确定性）。在双重干预试验中，当MOM不足以DHM而非配方奶补充时，NEC较低（RR 0.45（0.20-0.99），中等确定性）。结论：当前证据未能证明在相同人乳喂养基础上添加HumBMF相较于BovBMF具有临床优势。NEC的降低仅发生在DHM同时替代早产儿配方奶的情况下，不能归因于强化剂。 仅喂养类型。未来研究应将强化剂成分的独立效应与纯母乳喂养策略的效应区分开来。
完整摘要 · 英文原文
Background: Human milk-derived fortifiers (HumBMF) are an alternative to bovine protein-based fortifiers (BovBMF) for preterm infants, but their comparative effectiveness and safety remain uncertain. We evaluated the effects of HumBMF versus BovBMF in preterm or very low birth weight infants. Methods: Randomised controlled trials (RCTs) comparing use of HumBMF versus BovBMF to fortify human milk were identified through four databases and three trial registries (to 11 May 2026). At least two reviewers independently screened studies, extracted data, and assessed risk of bias. Fixed-effect meta-analyses and GRADE assessments were performed. Prespecified analyses separated trials comparing fortifier type alone, in which any mother's own milk (MOM) shortfall was supplemented with donor human milk (DHM) in both arms; and dual-intervention trials, in which MOM shortfall was also randomised to DHM in the HumBMF arm or preterm formula in the BovBMF arm. Results: Nine RCTs were included. In trials comparing fortifier type alone, there was no evidence that HumBMF reduced mortality (RR 0.60 (95% CI 0.29-1.23), low-certainty) or necrotising enterocolitis (NEC; RR 0.83 (0.39-1.78), very low-certainty). In dual-intervention trials, where MOM shortfall was supplemented with DHM rather than formula, NEC was lower (RR 0.45 (0.20-0.99), moderate-certainty). Conclusions: Current evidence does not demonstrate clinical advantages of HumBMF over BovBMF when added to the same human milk diet. Reductions in NEC occurred only where DHM also replaced preterm formula and cannot be attributed to fortifier type alone. Future research should distinguish the independent effects of fortifier composition from those of an exclusive human milk feeding strategy.
摘要 待译
Background: Human milk-derived fortifiers (HumBMF) are an alternative to bovine protein-based fortifiers (BovBMF) for preterm infants, but their comparative effectiveness and safety remain uncertain. We evaluated the effects of HumBMF versus BovBMF in preterm or very low birth weight infants. Methods: Randomised controlled trials (RCTs) comparing use of HumBMF versus BovBMF to fortify human milk were identified through four databases and three trial registries (to 11 May 2026). At least two reviewers independently screened studies, extracted data, and assessed risk of bias.…