Pammi Mohan, Abrams Steven A
Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, 6621, Fannin, MC.WT 6-104, Houston, Texas, USA, 77030.
Cochrane Database Syst Rev. 2011 Oct 5(10):CD007137. doi: 10.1002/14651858.CD007137.pub3.
Lactoferrin, a normal component of human colostrum, milk, tears and saliva can enhance host defence and may be effective in the prevention of sepsis and necrotizing enterocolitis (NEC) in preterm neonates.
To assess the safety and effectiveness of oral lactoferrin in the prevention of sepsis and NEC in preterm neonates.
We used the search strategy of the Cochrane Neonatal Review Group (CNRG) including searches of CENTRAL (The Cochrane Library), MEDLINE and PREMEDLINE, EMBASE and CINAHL. We also searched trials registries and the conference proceedings of Pediatric Academic Society. Searches updated in July 2011.
Randomized or quasi-randomized controlled trials evaluating oral lactoferrin at any dose or duration for the prophylaxis of sepsis or NEC in preterm neonates.
Data collection and analysis were performed according to the standard methods of the CNRG.
One trial (Manzoni 2008) that randomized 472 very low birth weight infants was eligible. A statistically significant reduction in late-onset sepsis was observed in the groups that received either lactoferrin alone (RR 0.34, 95% CI 0.17 to 0.70) or in combination with Lactobacillus rhamnosus GG (RR 0.27, 95% CI 0.12 to 0.60).In subgroup analyses, infants weighing less than 1000 g and those fed exclusively on maternal milk had a significant reduction in late-onset sepsis after oral lactoferrin supplementation alone. In the group supplemented with oral lactoferrin and Lactobacillus rhamnosus, infants weighing less than 1000 g had a significant reduction in late-onset sepsis, a result not seen in infants fed maternal milk exclusively.Prophylaxis with oral lactoferrin alone did not reduce the incidence of NEC (RR 0.33, 95% CI 0.09 to 1.17), but a significant reduction in NEC with a combination of lactoferrin and Lactobacillus rhamnosus GG was noted (RR 0.05, 95% CI 0.00 to 0.90).No adverse effects due to lactoferrin were observed in this study. Long-term neurological outcomes were not assessed in this trial.
AUTHORS' CONCLUSIONS: Oral lactoferrin prophylaxis reduces the incidence of late-onset sepsis in infants weighing less than 1500 g and most effective in infants weighing less than 1000 g. There is no evidence of efficacy of oral lactoferrin (given alone) in the prevention of NEC in preterm neonates.Well designed, randomized trials should address dosing, duration, type of lactoferrin (bovine or human) prophylaxis in prevention of sepsis and NEC. The effect of exclusive maternal milk feeding should be clarified.
乳铁蛋白是人类初乳、乳汁、眼泪和唾液中的一种正常成分，可增强宿主防御能力，可能对预防早产儿败血症和坏死性小肠结肠炎（NEC）有效。
评估口服乳铁蛋白预防早产儿败血症和NEC的安全性和有效性。
我们采用了Cochrane新生儿综述小组（CNRG）的检索策略，包括检索CENTRAL（Cochrane图书馆）、MEDLINE和PREMEDLINE、EMBASE和CINAHL。我们还检索了试验注册库和儿科学术协会的会议记录。检索于2011年7月更新。
评估任何剂量或疗程的口服乳铁蛋白预防早产儿败血症或NEC的随机或半随机对照试验。
根据CNRG的标准方法进行数据收集和分析。
一项将472例极低出生体重儿随机分组的试验（Manzoni 2008）符合要求。单独接受乳铁蛋白治疗的组（RR 0.34，95%CI 0.17至0.70）或与鼠李糖乳杆菌GG联合治疗的组（RR 0.27，95%CI 0.12至0.60）中，晚发性败血症的发生率有统计学意义的降低。在亚组分析中，体重小于1000g且仅母乳喂养的婴儿在单独补充口服乳铁蛋白后，晚发性败血症有显著降低。在补充口服乳铁蛋白和鼠李糖乳杆菌的组中，体重小于1000g的婴儿晚发性败血症有显著降低，而仅母乳喂养的婴儿未出现此结果。单独口服乳铁蛋白预防并未降低NEC的发生率（RR 0.33，95%CI 0.09至1.17），但乳铁蛋白与鼠李糖乳杆菌GG联合使用时，NEC发生率显著降低（RR 0.05，95%CI 0.00至0.90）。本研究未观察到乳铁蛋白引起的不良反应。本试验未评估长期神经学结局。
口服乳铁蛋白预防可降低体重小于1500g婴儿的晚发性败血症发生率，对体重小于1000g的婴儿最有效。没有证据表明口服乳铁蛋白（单独使用）对预防早产儿NEC有效。应通过设计良好的随机试验来研究预防败血症和NEC时乳铁蛋白的给药剂量、疗程、类型（牛乳铁蛋白或人乳铁蛋白）。应阐明纯母乳喂养的影响。
