Lin Hung-Chih, Su Bai-Horng, Chen An-Chyi, Lin Tsung-Wen, Tsai Chang-Hai, Yeh Tsu-Fuh, Oh William
Department of Pediatrics, China Medical University Hospital, China Medical University, 2 Yuh Der Rd, Taichung 404, Taiwan.
Pediatrics. 2005 Jan;115(1):1-4. doi: 10.1542/peds.2004-1463.
We evaluated the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.
A prospective, masked, randomized control trial was conducted to evaluate the beneficial effects of probiotics in reducing the incidence and severity of NEC among VLBW (<1500 g) infants. VLBW infants who started to fed enterally and survived beyond the seventh day after birth were eligible for the trial. They were randomized into 2 groups after parental informed consents were obtained. The infants in the study group were fed with Infloran (Lactobacillus acidophilus and Bifidobacterium infantis) with breast milk twice daily until discharged. Infants in the control group were fed with breast milk alone. The clinicians caring for the infants were blinded to the group assignment. The primary outcome was death or NEC (>or= stage 2).
Three hundred sixty-seven infants were enrolled: 180 in the study group and 187 in the control group. The demographic and clinical variables were similar in both groups. The incidence of death or NEC (>or= stage 2) was significantly lower in the study group (9 of 180 vs 24 of 187). The incidence of NEC (>or= stage 2) was also significantly lower in the study when compared with the control group (2 of 180 vs 10 of 187). There were 6 cases of severe NEC (Bell stage 3) in the control group and none in the study group. None of the positive blood culture grew Lactobacillus or Bifidobacterium species.
Infloran as probiotics fed enterally with breast milk reduces the incidence and severity of NEC in VLBW infants.
我们评估了益生菌对降低极低出生体重（VLBW）婴儿坏死性小肠结肠炎（NEC）发病率和严重程度的效果。
开展了一项前瞻性、双盲、随机对照试验，以评估益生菌对降低VLBW（<1500 g）婴儿NEC发病率和严重程度的有益作用。出生后开始经口喂养且存活超过7天的VLBW婴儿符合试验条件。获得家长知情同意后，将他们随机分为两组。研究组婴儿每天两次用英弗洛然（嗜酸乳杆菌和婴儿双歧杆菌）与母乳混合喂养，直至出院。对照组婴儿仅用母乳喂养。照料婴儿的临床医生对分组情况不知情。主要结局为死亡或NEC（≥2期）。
共纳入367名婴儿：研究组180名，对照组187名。两组的人口统计学和临床变量相似。研究组死亡或NEC（≥2期）的发生率显著低于对照组（180名中的9名 vs 187名中的24名）。与对照组相比，研究组NEC（≥2期）的发生率也显著更低（180名中的2名 vs 187名中的10名）。对照组有6例重度NEC（贝尔3期），研究组无。血培养阳性结果中均未培养出乳酸杆菌或双歧杆菌。
英弗洛然作为益生菌与母乳经口喂养可降低VLBW婴儿NEC的发病率和严重程度。
