含部分水解乳清蛋白配方奶粉的营养干预对高危婴儿出生后6个月内牛奶蛋白过敏和特应性皮炎的降低风险作用：过敏降低试验（A.R.T.），一项多中心双盲随机对照研究
The Risk Reduction Effect of a Nutritional Intervention With a Partially Hydrolyzed Whey-Based Formula on Cow's Milk Protein Allergy and Atopic Dermatitis in High-Risk Infants Within the First 6 Months of Life: The Allergy Reduction Trial (A.R.T.), a Multicenter Double-Blinded Randomized Controlled Study.
作者信息
Nicolaou Nicolaos, Pancheva Rouzha, Karaglani Eva, Sekkidou Mikaela, Marinova-Achkar Miglena, Popova Simoneta, Tzaki Margarita, Kapetanaki Anastasia, Iacovidou Nicoletta, Boutsikou Theodora, Iliodromiti Zoi, Papaevangelou Vassiliki, Sardeli Olympia, Xepapadaki Paraskevi, Papathoma Evangelia, Thijs-Verhoeven Inge, Kudla Urszula, Ulfman Laurien H, Schaafsma Anne, Manios Yannis
机构信息
Asthma and Allergy Centre, Limassol, Cyprus.
University of Nicosia Medical School, Nicosia, Cyprus.
出版信息
Front Nutr. 2022 May 25;9:863599. doi: 10.3389/fnut.2022.863599. eCollection 2022.
BACKGROUND
The role of partially hydrolyzed formulas (pHF) as part of nutritional interventions to prevent the development of allergic manifestations (AM) is questioned, and efficacy of each specific pHF should be substantiated.
OBJECTIVE
To investigate the risk-reduction effect of a whey-based pHF on the development of cow's milk protein allergy (CMPA) and atopic dermatitis (AD) in infants at high-risk for allergy within the first 6 months of life.
MATERIALS AND METHODS
In a multicenter double-blinded randomized controlled setting, healthy non-exclusively breastfed full-term infants, received either a specific whey-based pHF or a standard cow's milk-based formula (SF) and were clinically assessed for AM at 2, 4, and 6 months of age, supported by the objective scoring tools SCORAD and CoMiSS. CMPA was confirmed by open food challenge. Intention-to-Treat (ITT) and Per-Protocol (PP) analyses were performed.
RESULTS
Of 331 randomized subjects (ITT analysis set), 160 received the pHF and 171 the SF. Six (3.8%) infants in the pHF and 12 (7%) in the SF group developed CMPA ( = 0.186). AD incidence was significantly lower in those receiving pHF as compared to SF (10.6% vs. 18.7%, = 0.024) with a relative risk (RR, 95% CI) of 0.54 (0.32, 0.92), in particular when adjusting for family history of AD [6.5% vs. 27.3%, RR 0.24 (0.07, 0.78), = 0.018] representing a risk reduction of 76%. The PP analysis showed similar results.
CONCLUSION
This specific whey-based pHF reduced the risk of AD development, particularly in those with a family history of AD, and tended to reduce the development of CMPA in non-exclusively breastfed infants at high-risk for allergy. The A.R.T. study suggests that this particular pHF may contribute to measures aimed at prevention of allergic manifestations. However, further studies are needed to confirm this risk-reduction effect.
背景
部分水解配方奶粉（pHF）作为预防过敏表现（AM）的营养干预措施的作用受到质疑，每种特定pHF的疗效都应得到证实。
目的
研究基于乳清蛋白的pHF对出生后6个月内过敏高危婴儿发生牛奶蛋白过敏（CMPA）和特应性皮炎（AD）的风险降低作用。
材料与方法
在多中心双盲随机对照试验中，健康的非纯母乳喂养足月儿，分别接受特定的基于乳清蛋白的pHF或标准的基于牛奶的配方奶粉（SF），并在2、4和6月龄时通过客观评分工具SCORAD和CoMiSS进行AM的临床评估。通过开放食物激发试验确诊CMPA。进行意向性分析（ITT）和符合方案分析（PP）。
结果
在331名随机分组的受试者（ITT分析集）中，160人接受pHF，171人接受SF。pHF组有6名（3.8%）婴儿发生CMPA，SF组有12名（7%）（P = 0.186）。接受pHF的婴儿AD发病率显著低于接受SF的婴儿（10.6%对18.7%，P = 0.024），相对风险（RR，95%CI）为0.54（0.32，0.92），特别是在调整AD家族史后[6.5%对27.3%，RR 0.24（0.07，0.78），P = 0.018]，风险降低了76%。PP分析显示了相似的结果。
结论
这种特定的基于乳清蛋白的pHF降低了AD发生的风险，尤其是在有AD家族史的婴儿中，并且倾向于降低非纯母乳喂养的过敏高危婴儿发生CMPA的风险。A.R.T.研究表明，这种特定的pHF可能有助于采取预防过敏表现的措施。然而，需要进一步的研究来证实这种风险降低作用。
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