Comparison of a partially hydrolyzed infant formula with two extensively hydrolyzed formulas for allergy prevention:: A prospective, randomized study
Comparison of a partially hydrolyzed infant formula with two extensively hydrolyzed formulas for allergy prevention:: A prospective, randomized study
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DOI：
10.1034/j.1399-3038.2000.00081.x
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发表时间：
2000-08-01
影响因子：
4.4
通讯作者：
Host, A
中科院分区：
文献类型：
--
作者：
Halken, S;Hansen, KS;Host, A
本研究的目的是比较部分水解配方奶粉和两种广泛水解配方奶粉对过敏性疾病高风险婴儿的过敏预防效果。1994年6月至1995年7月期间，对来自丹麦四个中心的高危婴儿进行了调查。确定了595名高危婴儿。Night风险婴儿定义为患有双亲特应性，或单一特应性一级亲属合并脐带血免疫球蛋白E（IgE）大于或等于0.3 kU/l。出生时，所有婴儿均随机分配至三种不同的盲法配方奶粉中的一种。所有母亲在怀孕和哺乳期间的饮食不受限制，并鼓励纯母乳喂养。如果母乳喂养不足，根据随机化，在前4个月给予三种配方奶粉中的一种。建议不要引入牛奶，牛奶产品和固体食物，直到4个月大。在4个月大后，在需要时给予正常的无限制饮食和传统的基于牛奶的配方奶粉。所有婴儿在6个月、12个月和18个月时进行前瞻性随访和体格检查，并报告任何可能的特应性症状。如果怀疑食物过敏，则在医院环境中进行控制消除/激发程序。在纳入研究的550名婴儿中，514名在所有访视中均被观察到，36名因不依从而被排除在外。在478名完成研究的婴儿中，232名婴儿在出生后的前4个月内接受纯母乳喂养，79名接受广泛水解酪蛋白配方奶粉（Nutramigen），82名接受广泛水解乳清配方奶粉（Profylac），85名接受部分水解乳清配方奶粉（Nan WA）。这四组在特应性体质、脐带血IgE、出生地和性别方面是相同的。纯母乳喂养的儿童在家中接触烟草烟雾和宠物较少，属于较高的社会阶层，而三个配方奶粉组在环境因素方面是相同的。母乳喂养的频率很高;只有8名儿童（2%）根本没有母乳喂养。三个配方奶粉组在母乳喂养持续时间和开始食用配方奶粉和固体食物时的年龄方面相同。三组接受配方奶粉的婴儿在特应性皮炎或呼吸道症状的累积发病率方面没有显着差异。在12个月和18个月时，部分水解配方奶粉（Nan HA）喂养的儿童中父母报告的牛奶过敏累积发生率显著高于广泛水解配方奶粉（Nutramigen或Profylac）（NanHA，7.1%; Nutramigen，2.5%; Profylac，0%; p = 0.033）。纯母乳喂养的婴儿中确认的牛奶过敏的累积发生率为1.3%（3/232），喂养广泛水解配方奶粉（Nutramigen或Profylac）的婴儿中为0.6%，喂养部分水解配方奶粉（Nan HA）的婴儿中为4.7%（4/85）。部分水解配方奶粉在预防牛奶过敏方面的效果低于广泛水解配方奶粉，分别为0.6%和4.7%（p = 0.05），但由于病例数量较少，因此应谨慎解释结果。与其他类似的研究相比，特应性症状的频率较低，即使饮食干预不包括哺乳期的母亲饮食或3个月后的儿童饮食限制。
The aim of this study was to compare the allergy-preventive effect of a partially hydrolyzed formula with two extensively hydrolyzed formulas, in infants with a high risk for development of allergic disease. High-risk infants from four Danish centres were included in the period from June 1994 to July 1995. Five-hundred and ninety-five high-risk infants were identified. Nigh-risk infants were defined as having biparental atopy, or a single atopic first-degree relative combined with cord blood immunoglobulin E (IgE) greater than or equal to 0.3 kU/l, At birth all infants were randomized to one of three different blinded formulas. All mothers had unrestricted diets during pregnancy and lactation and were encouraged to breast-feed exclusively. If breastfeeding was insufficient, one of the three formulas, according to randomization, was given during the first 4 months. It was recommended not to introduce cow's milk, cow's milk products, and solid foods until the age of 4 months. After the age of 4 months a normal unrestricted diet and conventional cow's milk-based formula were given when needed. All infants were followed-up prospectively with interview and physical examination at the age of 6, 12, and 18 months, and if any possible atopic symptoms were reported. If food allergy was suspected, controlled elimination/challenge procedures were performed in a hospital setting. Of 550 infants included in the study, 514 were seen at all visits and 36 were excluded owing to noncompliance. Of 478 infants who completed the study, 232 were exclusively breast-fed, 79 received an extensively hydrolyzed casein formula (Nutramigen), 82 an extensively hydrolyzed whey formula (Profylac), and 85 a partially hydrolyzed whey formula (Nan WA), during the first 4 months of life. These four groups were identical in regard to atopic predisposition, cord blood IgE, birthplace, and gender. Exclusively breastfed children were exposed less to tobacco smoke and pets at home and belonged to higher social classes, whereas the three formula groups were identical concerning environmental factors. The frequency of breast-feeding was high; only eight (2%) children were not breast-fed at all. The three formula groups were identical in regard to duration of breast-feeding: and age at introduction of formula and solid foods. No significant differences were found in the three groups of infants receiving formula milk regarding the cumulative incidence of atopic dermatitis or respiratory symptoms. The cumulative incidence of parental-reported cow's milk allergy was significantly higher in children fed partially hydrolyzed formula (Nan HA) compared with extensively hydrolyzed formula (Nutramigen or Profylac) at 12 and 18 months (NanHA, 7.1%; Nutramigen, 2.5%; Profylac, 0%; p = 0.033). The cumulative incidence of confirmed cow's milk allergy was 1.3% (three of 232) in exclusively breast-fed infants, 0.6% tone of 161) in infants fed extensively hydrolyzed formula (Nutramigen or Profylac), and 4.7% (four of 85) in infants fed partially hydrolyzed formula (Nan HA). Partially hydrolyzed formula was found to be less effective than extensively hydrolyzed formula in preventing cow's milk allergy, 0.6% vs. 4.7% (p = 0.05), but because of the small number of cases the results should be interpreted with caution. Compared with other similar studies the frequency of atopic symptoms was low, even though the dietetic intervention did not include either maternal diet during lactation or dietary restrictions to the children after the age of 3 months.