A randomized synbiotic trial to prevent sepsis among infants in rural India
A randomized synbiotic trial to prevent sepsis among infants in rural India
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DOI：
10.1038/nature23480
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发表时间：
2017-08-24
期刊：
影响因子：
64.8
通讯作者：
Gewolb, Ira H.
中科院分区：
文献类型：
--
作者：
Panigrahi, Pinaki;Parida, Sailajanandan;Gewolb, Ira H.
婴儿早期败血症导致全世界每年100万人死亡，其中大多数在发展中国家。目前没有有效的预防手段。在这里，我们报告了一项随机，双盲，安慰剂对照试验的口服合生元制剂（植物乳杆菌加低聚果糖）在农村印度新生儿。我们招募了4，556名出生时至少2，000 g，妊娠至少35周，并且没有败血症或其他疾病的迹象的婴儿，并对他们进行了60天的监测。我们发现治疗组的主要结局（脓毒症和死亡的组合）显著降低（风险比0.60，95%置信区间0.48-0.74），死亡人数很少（安慰剂组4例，合生元组6例）。还观察到培养阳性和培养阴性脓毒症和下呼吸道感染的显著减少。这些发现表明，在发展中国家，使用含L.植物ATCC-202195。
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.