一项关于在急性腹泻儿童中补充布拉酵母菌的无乳糖配方奶粉的多中心研究

[A multicentric study of a lactose free formula supplemented with Saccharomyces boulardii in children with acute diarrhea].

作者信息

Le Luyer B, Makhoul G, Duhamel J-F

机构信息

Département de pédiatrie, groupe hospitalier du Havre, 55 bis, rue Gustave-Flaubert, 76083 Le Havre cedex, France.

出版信息

Arch Pediatr. 2010 May;17(5):459-65. doi: 10.1016/j.arcped.2010.02.004. Epub 2010 Mar 16.

DOI:10.1016/j.arcped.2010.02.004

PMID:20236813

Abstract

AIM OF THE STUDY

In a double-blind, randomized, controlled, multicentric study, the study compared the efficacy of a specific adapted formula (lactose-free, high-mineral, low-osmolarity formula, containing rice and pectin fortified with Saccharomyces boulardii) in the management of infants with acute diarrhea with a standard formula used to feed healthy infants from birth.

METHODOLOGY

Seventy infants with an average age of 163 days+/-11.7 suffering from acute diarrhea with an average of 6.6+/-0.4 stools per day received, after randomization, either a standard (control) formula (n=36) or an adapted lactose-free formula fortified with S. boulardii (26mg/100ml; n=34). The duration of the diarrhea was defined as the time needed until the occurrence of the first normal stool after the last liquid stool.

RESULTS

At inclusion, the age, weight, and number of stools per day were the same in the two groups. There were 15 infants with rotavirus in the treated group and 13 in the control group. The duration of the diarrhea from time of inclusion was significantly reduced in the treated group (35.4+/-3.7h) versus the control group (67.1+/-5h; p<0.001), In both groups, with or without rotavirus, the duration of diarrhea did not depend on the presence or absence of rotavirus but only on the treatment. The average daily weight gain was significantly higher in the treated group compared with the control group (74.2+/-26.4g versus 23.7+/-6.7g; p<0.05). The oral rehydration solution consumption was, however, higher in the control group than in the treated group; the consumption of formula was higher in the treated group, but these differences were not significant. The number of stools as of Day 4 remained significantly higher in the control group than in the treated group. After 6.5 days, almost no S. boulardii was found in the stools.

CONCLUSION

In moderately dehydrated infants (<10 %), the use of a specially designed formula, containing S. boulardii (Novalac AD+/Diarinova+), significantly shortens the duration of diarrhea and allows quicker weight regain than a standard formula.

摘要

研究目的

在一项双盲、随机、对照、多中心研究中，该研究比较了一种特殊的适配配方奶粉（无乳糖、高矿物质、低渗透压配方奶粉，含有添加了布拉酵母菌的大米和果胶）与用于喂养健康新生儿的标准配方奶粉在治疗婴儿急性腹泻方面的疗效。

方法

70名平均年龄为163天±11.7天、患有急性腹泻且平均每天排便6.6次±0.4次的婴儿，随机分组后，一组接受标准（对照）配方奶粉（n = 36），另一组接受添加了布拉酵母菌（26mg/100ml；n = 34）的无乳糖适配配方奶粉。腹泻持续时间定义为从最后一次稀便到首次出现正常大便所需的时间。

结果

纳入研究时，两组婴儿的年龄、体重和每日排便次数相同。治疗组有15名感染轮状病毒的婴儿，对照组有13名。与对照组（67.1±5小时；p<0.001）相比，治疗组从纳入研究时起的腹泻持续时间显著缩短（35.4±3.7小时）。在两组中，无论有无轮状病毒感染，腹泻持续时间均不取决于是否感染轮状病毒，而仅取决于治疗方法。治疗组的平均每日体重增加显著高于对照组（74.2±26.4克对23.7±6.7克；p<0.05）。然而，对照组口服补液盐的消耗量高于治疗组；治疗组配方奶粉的消耗量更高，但这些差异不显著。到第4天，对照组的排便次数仍显著高于治疗组。6.5天后，粪便中几乎未检测到布拉酵母菌。