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补充牛乳铁蛋白预防低出生体重新生儿晚发性败血症的疗效:一项随机安慰剂对照临床试验。

Efficacy of Bovine Lactoferrin Supplementation in Preventing Late-onset Sepsis in low Birth Weight Neonates: A Randomized Placebo-Controlled Clinical Trial.

作者信息

Kaur Gurpreet, Gathwala Geeta

机构信息

Department of Pediatrics, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana 124001, India

Department of Pediatrics, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana 124001, India.

出版信息

J Trop Pediatr. 2015 Oct;61(5):370-6. doi: 10.1093/tropej/fmv044. Epub 2015 Jul 29.

DOI:10.1093/tropej/fmv044
PMID:26224129
Abstract

OBJECTIVES

To evaluate the efficacy of bovine lactoferrin (BLF) in preventing first episode of late-onset sepsis (LOS) in low birth weight (LBW) neonates.

METHODS

In this study conducted from May 2012 to July 2013 in the neonatal intensive care unit (NICU) of a tertiary care hospital, inborn asymptomatic neonates, <2000 g, admitted to NICU in first 12 h of birth with no maternal risk factors for sepsis were randomized to receive BLF or placebo from 1st to 28th day of life. The incidence of culture-proven sepsis and sepsis-attributable mortality after 72 h of life was recorded. Increasing doses of BLF were used with higher birth weights.

RESULTS

Incidence of first episode of culture-proven LOS was significantly lower in the BLF group vs. placebo [2/63 (3.2%) vs. 9/67(13.4%); risk ratio, 0.211; 95% CI, 0.044-1.019; p = 0.036]. Statistically significant reduction in the sepsis-attributable mortality was also seen after use of prophylactic BLF [0/63 (0%) vs. 5/67 (7.5%); p = 0.027].

CONCLUSION

BLF supplementation in LBW neonates reduced the incidence of first episode of LOS.

摘要

目的

评估牛乳铁蛋白(BLF)预防低出生体重(LBW)新生儿晚发性败血症(LOS)首次发作的疗效。

方法

本研究于2012年5月至2013年7月在一家三级医院的新生儿重症监护病房(NICU)进行,将出生体重<2000g、出生后12小时内入住NICU且无母亲败血症危险因素的先天性无症状新生儿随机分为两组,在出生后第1天至第28天分别接受BLF或安慰剂治疗。记录出生后72小时后经培养证实的败血症发病率和败血症归因死亡率。出生体重越高,BLF使用剂量越大。

结果

与安慰剂组相比,BLF组经培养证实的LOS首次发作的发病率显著降低[2/63(3.2%)对9/67(13.4%);风险比,0.211;95%CI,0.044 - 1.019;p = 0.036]。使用预防性BLF后,败血症归因死亡率也有统计学意义的显著降低[0/63(0%)对5/67(7.5%);p = 0.027]。

结论

补充BLF可降低LBW新生儿LOS首次发作的发病率。

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