Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants.
Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants.
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早产儿 Talactoferrin 口服溶液的随机对照试验。
DOI：
10.1016/j.jpeds.2016.04.084
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Petrak,Karel
中科院分区：
文献类型：
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作者：
Sherman,MichaelP;Adamkin,DavidH;Niklas,Victoria;Radmacher,Paula;Sherman,Jan;Wertheimer,Fiona;Petrak,Karel
目的评价重组人乳铁蛋白（talactoferrin，TLf）的安全性和降低感染的有效性。婴儿在出生后第1天至第28天接受肠内TLf（n = 60）或安慰剂（n = 60）; TLf剂量为每12小时150 mg/kg。主要转归为菌血症、肺炎、尿路感染、脑膜炎和坏死性小肠结肠炎（NEC）。次要结局为败血症综合征和疑似NEC。我们记录了临床，实验室和放射学的结果，沿着疾病和不良事件，在用于统计analysis.ResultsDemographic数据的数据库中的两组婴儿相似。我们没有将肠内或器官特异性不良事件归因于TLf。TLf组有2例死亡（各1例死于后颅窝出血和出院后婴儿猝死），安慰剂组有1例死于NEC。与安慰剂组相比，TLf组的医院获得性感染率低50%（P<0.04），包括血液或管路感染、尿路感染和肺炎较少。TLf组中有14名出生时体重<1 kg的婴儿没有革兰氏阴性菌感染，而安慰剂组中只有3名。非感染性的结果是没有统计学显着差异的两组之间，并没有组间差异的增长或神经发育超过1年posthospitalizationperiod.ConclusionWe发现没有临床或实验室毒性和趋势，减少感染性发病率的婴儿治疗TLf.Trial registrationClinicalTrials.gov：NCT 00854633。
ObjectiveTo evaluate the safety and explore the efficacy of recombinant human lactoferrin (talactoferrin [TLf]) to reduce infection.Study designWe conducted a randomized, double blind, placebo-controlled trial in infants with birth weight of 750-1500 g. Infants received enteral TLf (n = 60) or placebo (n = 60) on days 1 through 28 of life; the TLf dose was 150 mg/kg every 12 hours. Primary outcomes were bacteremia, pneumonia, urinary tract infection, meningitis, and necrotizing enterocolitis (NEC). Secondary outcomes were sepsis syndrome and suspected NEC. We recorded clinical, laboratory, and radiologic findings, along with diseases and adverse events, in a database used for statistical analyses.ResultsDemographic data were similar in the 2 groups of infants. We attributed no enteral or organ-specific adverse events to TLf. There were 2 deaths in the TLf group (1 each due to posterior fossa hemorrhage and postdischarge sudden infant death), and 1 death in the placebo group, due to NEC. The rate of hospital-acquired infections was 50% lower in the TLf group compared with the placebo group (P< .04), including fewer blood or line infections, urinary tract infections, and pneumonia. Fourteen infants in the TLf group weighing <1 kg at birth had no gram-negative infections, compared with only 3 of 14 such infants in the placebo group. Noninfectious outcomes were not statistically significantly different between the 2 groups, and there were no between-group differences in growth or neurodevelopment over a 1-year posthospitalization period.ConclusionWe found no clinical or laboratory toxicity and a trend toward less infectious morbidity in the infants treated with TLf.Trial registrationClinicalTrials.gov: NCT00854633.