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人乳强化剂在经肠道喂养的早产儿和/或低出生体重儿中的安全性和有效性:系统评价和荟萃分析。

Safety and efficacy of human milk-based fortifier in enterally fed preterm and/or low birthweight infants: a systematic review and meta-analysis.

机构信息

Department of Neonatal Medicine, Women's and Children's Hospital, North Adelaide, South Australia, Australia.

Women and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.

出版信息

Arch Dis Child Fetal Neonatal Ed. 2021 Mar;106(2):137-142. doi: 10.1136/archdischild-2020-319406. Epub 2020 Sep 17.

DOI:10.1136/archdischild-2020-319406
PMID:32943531
Abstract

OBJECTIVE

To conduct a systematic review and meta-analysis of the efficacy and safety of fortification of human milk with human milk-based fortifier versus cow's milk-based fortifier for use in preterm and/or very low birthweight infants.

DESIGN

Randomised or quasi-randomised controlled trials comparing the effect of human milk fortification with human milk-based milk fortifier versus cow's milk-based fortifier in infants born <34 weeks' gestation and/or with birth weight <1500 g were identified by searching databases, clinical trial registries and reference lists until 5 November 2019. Two authors independently extracted data and assessed evidence quality. Meta-analyses were conducted using fixed or random effects models, as appropriate.

MAIN OUTCOME MEASURES

Necrotising enterocolitis (Bell's stage II or higher) and late-onset sepsis.

RESULTS

Of 863 unique records identified, 16 full-text trials were screened and 2 trials involving 334 infants were included. Primary outcome data were available for 332 infants. Use of human milk-based fortifier compared with cow's milk-based fortifier reduced the risk of necrotising enterocolitis (risk ratio 0.47, 95% CI 0.22 to 0.98). There was no clear evidence of an effect on late-onset sepsis or any other outcomes. The quality of evidence was low to very low due to imprecision and lack of blinding in one study.

CONCLUSIONS

Findings suggest that there is a reduction in the incidence of necrotising enterocolitis with human milk-based fortifiers compared with cow's milk-based fortifiers. The overall quality of evidence is low. Further appropriately powered trials are required before this intervention can be routinely recommended for preterm infants.

摘要

目的

系统评价和荟萃分析人乳强化剂与人乳基强化剂和牛乳基强化剂在早产儿和/或极低出生体重儿中的疗效和安全性。

设计

通过搜索数据库、临床试验注册处和参考文献列表,确定了比较 34 周以下妊娠和/或出生体重<1500g 的婴儿用人乳基强化剂与牛乳基强化剂强化人乳的随机或准随机对照试验。两名作者独立提取数据并评估证据质量。适当情况下使用固定或随机效应模型进行荟萃分析。

主要结局指标

坏死性小肠结肠炎(Bell 分期 II 级或更高)和晚发性败血症。

结果

在 863 条独特记录中,筛选了 16 篇全文试验,纳入了 2 项涉及 334 名婴儿的试验。332 名婴儿有主要结局数据。与牛乳基强化剂相比,使用人乳基强化剂可降低坏死性小肠结肠炎的风险(风险比 0.47,95%CI 0.22 至 0.98)。没有明确证据表明对晚发性败血症或任何其他结局有影响。由于一项研究的精度和缺乏盲法,证据质量低至极低。

结论

研究结果表明,与人乳基强化剂相比,牛乳基强化剂可降低坏死性小肠结肠炎的发生率。总体证据质量较低。需要进一步进行适当规模的试验,才能常规推荐该干预措施用于早产儿。

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