对于未能对蛋白水解配方起效的牛奶过敏婴儿，给予氨基酸配方奶进行治疗：一项随机双盲试验。
A thickened amino-acid formula in infants with cow's milk allergy failing to respond to protein hydrolysate formulas: a randomized double-blind trial.
机构信息
Pediatric Gastroenterology, Hepatology and Nutrition Department, Necker Children's Hospital, 149, rue de Sèvres, 75015, Paris, France,
出版信息
Paediatr Drugs. 2014 Dec;16(6):513-22. doi: 10.1007/s40272-014-0097-x.
INTRODUCTION
Amino-acid-based formulas (AAFs) are recommended for children with cow's milk protein allergy (CMPA) failing to respond to extensively hydrolyzed formulas (eHFs).
OBJECTIVE
This study aimed to assess the tolerance/hypoallergenicity and efficacy of a thickened AAF (TAAF) in these infants.
METHODS
This multicenter, double-blind, randomized controlled trial (NCT01940068) compared 3-month feeding with a pectin-based TAAF (Novalac(®), United Pharmaceuticals, Paris, France) and a commercially available "reference" AAF (RAAF; Neocate(®), Nutricia, Germany) in infants aged <18 months with CMPA and persistent allergy symptoms with eHF feeding. Reported here are the results of an interim analysis after 1 month of feeding.
RESULTS
Of the 86 infants randomized, CMPA with eHF intolerance was confirmed in 75 infants; all of them tolerated the allocated AAFs. The major allergic symptom disappeared within 1 month in 61.9 and 51.5 % and regurgitations disappeared in 66.7 and 42.3 % of infants who received TAAF and RAAF, respectively. Infants had significantly more normal stools (soft or formed consistency) with the TAAF (90.5 vs. 66.7 %; p = 0.011). From baseline, daily family life significantly improved with both AAFs: crying time decreased by 97.3 (p < 0.001) and 28.6 min (p = 0.014) and sleeping time increased by 64.6 (p = 0.009) and 29.0 min with TAAF and RAAF, respectively. At day 30, weight and body mass index z-score gains were 0.1 and 0.2 with TAAF and 0.2 and 0.0 with RAAF.
CONCLUSION
Both AAFs were well tolerated by infants with CMPA and eHF intolerance and ensured appropriate growth, with the TAAF providing additional comfort.
简介
对于未能对深度水解配方（eHF）产生反应的牛奶蛋白过敏（CMPA）患儿，推荐使用氨基酸配方（AAF）。
目的
本研究旨在评估这种增厚型 AAF（TAAF）在这些婴儿中的耐受性/低致敏性和疗效。
方法
这是一项多中心、双盲、随机对照试验（NCT01940068），比较了果胶基 TAAF（Novalac(®)，United Pharmaceuticals，巴黎，法国）和市售“参照”AAF（RAAF；Neocate(®)，Nutricia，德国）在年龄<18 个月、对 eHF 喂养不耐受且持续存在过敏症状的 CMPA 婴儿中的 3 个月喂养效果。此处报告的是喂养 1 个月后的中期分析结果。
结果
在 86 名随机分组的婴儿中，75 名婴儿被证实患有 CMPA 和 eHF 不耐受；他们均耐受所分配的 AAF。61.9%和 51.5%的患儿在 1 个月内主要过敏症状消失，66.7%和 42.3%的患儿分别出现反流消失。TAAF 组婴儿的粪便更正常（柔软或成形），占 90.5%，而 RAAF 组仅为 66.7%（p=0.011）。与基线相比，两组 AAF 均使每日家庭生活显著改善：TAAF 组哭闹时间分别减少 97.3（p<0.001）和 28.6 分钟（p=0.014），睡眠时间分别增加 64.6（p=0.009）和 29.0 分钟；RAAF 组分别为 28.6 分钟和 29.0 分钟。在第 30 天，TAAF 和 RAAF 组的体重和体重指数 z 评分增加分别为 0.1 和 0.2，0.2 和 0.0。
结论
两种 AAF 均耐受良好，且能确保 CMPA 和 eHF 不耐受婴儿的适当生长，TAAF 还能提供额外的舒适度。
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