Department of Epidemiology, Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Nebraska, USA.
Department of Pediatrics, Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Nebraska, USA.
Nature. 2017 Aug 24;548(7668):407-412. doi: 10.1038/nature23480. Epub 2017 Aug 16.
Sepsis in early infancy results in one million annual deaths worldwide, most of them in developing countries. No efficient means of prevention is currently available. Here we report on a randomized, double-blind, placebo-controlled trial of an oral synbiotic preparation (Lactobacillus plantarum plus fructooligosaccharide) in rural Indian newborns. We enrolled 4,556 infants that were at least 2,000 g at birth, at least 35 weeks of gestation, and with no signs of sepsis or other morbidity, and monitored them for 60 days. We show a significant reduction in the primary outcome (combination of sepsis and death) in the treatment arm (risk ratio 0.60, 95% confidence interval 0.48-0.74), with few deaths (4 placebo, 6 synbiotic). Significant reductions were also observed for culture-positive and culture-negative sepsis and lower respiratory tract infections. These findings suggest that a large proportion of neonatal sepsis in developing countries could be effectively prevented using a synbiotic containing L. plantarum ATCC-202195.
在婴儿早期发生的败血症，导致全球每年有一百万人死亡，其中大多数发生在发展中国家。目前尚无有效的预防手段。在这里，我们报告了一项针对农村印度新生儿的口服共生制剂（植物乳杆菌加低聚果糖）的随机、双盲、安慰剂对照试验。我们招募了 4556 名出生时体重至少 2000 克、妊娠至少 35 周且没有败血症或其他疾病迹象的婴儿，并对他们进行了 60 天的监测。我们发现治疗组的主要结局（败血症和死亡的组合）显著降低（风险比 0.60，95%置信区间 0.48-0.74），死亡人数较少（安慰剂组 4 人，共生制剂组 6 人）。对于培养阳性和培养阴性败血症以及下呼吸道感染，也观察到了显著的降低。这些发现表明，使用含有植物乳杆菌 ATCC-202195 的共生制剂，可以有效预防发展中国家新生儿败血症的很大一部分。
