Clements M L, Levine M M, Black R E, Robins-Browne R M, Cisneros L A, Drusano G L, Lanata C F, Saah A J
Antimicrob Agents Chemother. 1981 Jul;20(1):104-8. doi: 10.1128/AAC.20.1.104.
In vitro and animal experiments indicated that lactobacilli might prevent Escherichia coli from colonizing the intestine and may produce substances counteracting enterotoxin. Lactinex, a commercial preparation of dried Lactobacillus acidophilus and L. bulgaricus, is marketed for uncomplicated diarrhea. Preliminary experiments in nonfasting volunteers indicated that lactobacilli in this preparation colonized the small intestine for up to 6 h. To evaluate the protective efficacy of Lactinex, a double-blind randomized study was carried out in which 48 volunteers (23 receiving Lactinex and 25 receiving placebos) were challenged with E. coli strains that produced heat-stable or heat-labile enterotoxins or both. No significant differences between the two groups were noted with respect to attack rate, incubation period, duration of diarrhea, volume and number of liquid stools, and coproculture yields. These data suggest that this lactobacillus preparations does not prevent or alter the course of enterotoxigenic E. coli diarrhea in adults. Lack of efficacy occurred despite efforts to maximize small bowel colonization, including administration of Lactinex in milk and in a 6-hour-interval regimen during 36 h before and 96 h after challenge.
体外和动物实验表明，乳酸杆菌可能会阻止大肠杆菌在肠道内定植，并可能产生对抗肠毒素的物质。Lactinex是一种嗜酸乳杆菌和保加利亚乳杆菌的商业干燥制剂，用于治疗单纯性腹泻。在非禁食志愿者身上进行的初步实验表明，该制剂中的乳酸杆菌可在小肠内定植长达6小时。为了评估Lactinex的保护效果，开展了一项双盲随机研究，48名志愿者（23名接受Lactinex，25名接受安慰剂）受到产生热稳定或热不稳定肠毒素或两者皆有的大肠杆菌菌株攻击。两组在发病率、潜伏期、腹泻持续时间、液体粪便量和数量以及粪便培养产量方面均未发现显著差异。这些数据表明，这种乳酸杆菌制剂并不能预防或改变成人产肠毒素大肠杆菌腹泻的病程。尽管已努力使小肠定植最大化，包括在牛奶中服用Lactinex，并在攻击前36小时和攻击后96小时采用每6小时一次的给药方案，但仍未显示出疗效。
