Double-Blind Comparative Trial With 2 Antiregurgitation Formulae
Double-Blind Comparative Trial With 2 Antiregurgitation Formulae
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DOI：
10.1097/mpg.0b013e318299993e
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发表时间：
2013-09-01
影响因子：
2.9
通讯作者：
Bocquet, A.
中科院分区：
文献类型：
--
作者：
Vandenplas, Y.;Leluyer, B.;Bocquet, A.
背景和目的：许多母亲咨询医生，因为频繁的婴儿返流。指南建议将安慰和饮食治疗作为首选方法。本研究的目的是测试和比较2抗反流配方奶粉（ARF）的疗效。方法：一项前瞻性，双盲，随机交叉试验进行了为期1个月的115配方奶粉喂养的婴儿（年龄2周-5个月）比较2 ARF（ARF-1：非水解蛋白，刺槐豆胶; ARF-2：特定乳清水解产物，刺槐豆胶，特殊处理的淀粉）。主要终点是反流的发病率。结果：在纳入，平均年龄为9.1周，人体测量参数组间没有差异。根据意向性治疗分析，ARF-1的平均返流发作次数从8.25次降至2.32次，ARF-2降至1.89次（两种ARF之间存在统计学显著差异，P=0.0091）。ARF-2组的平均限制体积评分比ARF-1组显著降低（P=0.0265）。两组之间的大便频率和一致性没有显着差异。结论：两种ARF的疗效证明了减少的数量和体积的排便。ARF-2在统计学上比ARF-1更有效。比较试验可以选择最佳治疗方案。
Background and Aim:Many mothers consult physicians because of frequent infant regurgitation. Guidelines recommend reassurance and dietary treatment as first approaches. The aim of the present study was to test and compare the efficacy of 2 antiregurgitation formulae (ARF).Methods:A prospective, double-blind, randomized cross-over trial was performed for a 1-month period in 115 formula-fed infants (ages 2 weeks-5 months) comparing 2 ARF (ARF-1: nonhydrolyzed protein, locust bean gum; ARF-2: specific whey hydrolysate, locust bean gum, specially treated starch). The primary endpoint was the incidence of regurgitation.Results:At inclusion, mean age was 9.1 weeks; anthropometric parameters did not differ between the groups. According to the intention-to-treat analysis, the mean number of episodes of regurgitation decreased from 8.25 to 2.32 with ARF-1 and to 1.89 with ARF-2 (statistically significant difference between both ARF, P=0.0091). The mean score of regurgitated volume decreased significantly more with ARF-2 than with ARF-1 (P=0.0265). There was no significant difference in stool frequency and consistency between both groups.Conclusions:The efficacy of both ARF was demonstrated by the decreased number and volume of regurgitations. ARF-2 was statistically more effective than ARF-1. Comparative trials enable the selection of the best therapeutic option.