Lemoine Anaïs, Nieto-García Antonio, Nieto-Cid María, Espín-Jaime Beatriz, Mazón Ángel, Salhi Hocine, Salamouras Dimitrios, Kalach Nicolas, de Castellar-Sansó Roser, Delgado Ojeda Jesús, Navas-López Víctor Manuel
Service de Nutrition et Gastro-Entérologie Pédiatrique, Hôpital Armand Trousseau AP HP, Sorbonne Université, 75571 Paris, France.
Unidad de Neumología y Alergia Infantil, Hospital Universitari y Politècnic La Fe, Instituto de Investigación Sanitaria La Fe, 46026 Valencia, Spain.
Nutrients. 2024 Dec 31;17(1):162. doi: 10.3390/nu17010162.
: Hydrolysed rice formula (HRF) is tolerated by >90% of children with cow's milk protein allergy (CMPA). However, concerns have been raised about potential suboptimal growth in infants fed HRF compared to those fed an extensively hydrolysed milk protein formula (eHF). : To compare growth, safety and tolerance acquisition in infants with CMPA when fed HRF versus eHF. : A multicentre prospective, randomised, double-blind, placebo-controlled food challenge trial was conducted with infants with CMPA. The infants received either HRF or eHF over a 12-month follow-up period. The primary outcome measure was the change from baseline over the study period in weight-for-length expressed as a Z-score. The secondary outcomes were other anthropometric measurements, tolerability and adverse events (AEs). : In total, 105 children were enrolled. The weight-for-length measurements were -0.01 (HRF) and -0.29 (eHF) at baseline and 0.29 and 0.05, respectively, at the last visit, with no significant between-group difference = 0.28; mixed-effects model). The Z-scores for other anthropometric variables indicated normal growth, with no significant between-group differences. In total, 29 potentially product-related AEs were reported (12 in the HRF group and 17 in the eHF group). A trend was observed toward a faster acquisition of tolerance in the HRF group (median age: 20.4 months) compared to the eHF group (16.3 months), but this was not statistically significant ( = 0.18). : HRF demonstrated appropriate growth, acquisition of tolerance and a good safety profile in infants with CMPA, with no significant differences versus eHF. HRF could be considered as an appropriate option in the management of CMPA.
水解大米配方奶粉（HRF）能被超过90%的牛奶蛋白过敏（CMPA）儿童耐受。然而，与喂食深度水解乳蛋白配方奶粉（eHF）的婴儿相比，人们对喂食HRF的婴儿潜在的生长发育欠佳表示担忧。
比较CMPA婴儿喂食HRF与eHF时的生长情况、安全性和耐受性获得情况。
对CMPA婴儿进行了一项多中心前瞻性、随机、双盲、安慰剂对照食物激发试验。婴儿在12个月的随访期内接受HRF或eHF。主要结局指标是研究期间身长体重Z评分相对于基线的变化。次要结局是其他人体测量指标、耐受性和不良事件（AE）。
共纳入105名儿童。基线时身长体重测量值在HRF组为-0.01，在eHF组为-0.29；末次随访时分别为0.29和0.05，组间差异无统计学意义（P = 0.28；混合效应模型）。其他人体测量变量的Z评分表明生长正常，组间差异无统计学意义。共报告了29例可能与产品相关的AE（HRF组12例，eHF组17例）。观察到HRF组（中位年龄：20.4个月）与eHF组（16.3个月）相比有更快获得耐受性的趋势，但无统计学意义（P = 0.18）。
HRF在CMPA婴儿中显示出适当的生长、耐受性获得和良好的安全性，与eHF相比无显著差异。HRF可被视为CMPA管理中的一个合适选择。
