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. 2019 May 11;5(5):CD007138. doi: 10.1002/14651858.CD007138.pub4.
Neonatal sepsis and necrotizing enterocolitis (NEC) cause significant neonatal mortality and morbidity despite appropriate antibiotic therapy. Enhancing host defense and modulating inflammation by using lactoferrin as an adjunct to antibiotics in the treatment of sepsis, NEC, or both, may improve clinical outcomes.
The primary objective was to assess safety and efficacy of oral lactoferrin as an adjunct to antibiotics in the treatment of neonates with suspected or confirmed sepsis, NEC, or both.
We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 9), MEDLINE via PubMed, PREMEDLINE, (1966 to 20 September 2018) Embase (1980 to 20 September 2018), and CINAHL (1982 to 20 September 2018). We also searched clinical trial databases, conference proceedings, the reference lists of retried articles and clinical trials, and the authors' personal files.
We included randomized or quasi-randomized controlled trials evaluating enteral lactoferrin (at any dose or duration), used as an adjunct to antibiotic therapy, compared with antibiotic therapy alone (with or without placebo) or other adjuncts to antibiotic therapy to treat neonates at any gestational age up to 44 weeks' postmenstrual age with confirmed or suspected sepsis or necrotizing enterocolitis (Bell's Stage II or III).
We used the standardized methods of Cochrane Neonatal for conducting a systematic review and for assessing the methodological quality of studies (neonatal.cochrane.org/en/index.html). The titles and the abstracts of studies identified by the search strategy were independently assessed by the two review authors and full text versions were obtained for assessment if necessary. Forms were designed to record trial inclusion/exclusion and data extraction. We used the GRADE approach to assess the quality of evidence.
We did not identify any eligible trials evaluating lactoferrin for the treatment of neonatal sepsis or NEC.
AUTHORS' CONCLUSIONS: Implications for practice: currently there is no evidence to support or refute the use of enteral lactoferrin, as an adjunct to antibiotic therapy, for the treatment of neonatal sepsis or necrotizing enterocolitis.
given the lack of efficacy of enteral lactoferrin for preventing late-onset sepsis and necrotizing enterocolitis, evaluation of enteral lactoferrin as an adjunctive agent for treatment of sepsis or necrotizing enterocolitis does not appear to be a research priority.
尽管进行了适当的抗生素治疗，新生儿败血症和坏死性小肠结肠炎（NEC）仍会导致显著的新生儿死亡率和发病率。在败血症、NEC或两者的治疗中，使用乳铁蛋白作为抗生素的辅助手段来增强宿主防御和调节炎症，可能会改善临床结局。
主要目的是评估口服乳铁蛋白作为抗生素辅助手段治疗疑似或确诊败血症、NEC或两者的新生儿的安全性和有效性。
我们采用Cochrane新生儿组的标准检索策略，检索Cochrane对照试验中央注册库（CENTRAL 2018年第9期）、通过PubMed检索MEDLINE、PREMEDLINE（1966年至2018年9月20日）、Embase（1980年至2018年9月20日）以及CINAHL（1982年至2018年9月20日）。我们还检索了临床试验数据库、会议论文集、检索到的文章和临床试验的参考文献列表以及作者的个人文件。
我们纳入了随机或半随机对照试验，这些试验评估了肠内乳铁蛋白（任何剂量或疗程）作为抗生素治疗的辅助手段，与单独使用抗生素治疗（有或无安慰剂）或抗生素治疗的其他辅助手段进行比较，以治疗月经龄达44周的任何胎龄的确诊或疑似败血症或坏死性小肠结肠炎（贝尔分期II或III期）的新生儿。
我们采用Cochrane新生儿组的标准化方法进行系统评价并评估研究的方法学质量（neonatal.cochrane.org/en/index.html）。由检索策略确定的研究的标题和摘要由两位综述作者独立评估，如有必要获取全文版本进行评估。设计表格记录试验的纳入/排除情况和数据提取。我们采用GRADE方法评估证据质量。
我们未找到任何评估乳铁蛋白治疗新生儿败血症或NEC的合格试验。
对实践的启示：目前没有证据支持或反驳将肠内乳铁蛋白作为抗生素治疗的辅助手段用于治疗新生儿败血症或坏死性小肠结肠炎。
鉴于肠内乳铁蛋白预防晚发性败血症和坏死性小肠结肠炎缺乏疗效，评估肠内乳铁蛋白作为败血症或坏死性小肠结肠炎治疗的辅助药物似乎不是研究重点。
