一种新型氨基酸配方奶粉对牛奶过敏且不耐受水解奶粉婴儿的安全性
Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates.
作者信息
Dupont Christophe, Kalach Nicolas, Soulaines Pascale, Bradatan Elena, Lachaux Alain, Payot François, De Blay Frédéric, Guénard-Bilbault Lydie, Hatahet Riad, Mulier Sandra, Kapel Nathalie, Waligora-Dupriet Anne-Judith, Butel Marie-José
机构信息
*Pediatric Gastroenterology, Hepatology and Nutrition Department, Necker Children's Hospital, Paris, France †Saint Antoine Clinics of Pediatrics, Saint Vincent de Paul Hospital, Groupement des Hôpitaux de l'Institut Catholique, Lille, France ‡Department of Pediatrics, Regional Hospital, Namur, Belgium §Gastroenterology, Hepatology and Nutrition Unit, University and Pediatric Hospital of Lyon, Lyon, France ||Pulmonology and Allergology Department, Regional University Hospital, Strasbourg, France ¶private allergy medical practice, Illkirch-Graffenstaden #private allergy medical practice, Forbach, France **Allergology Department, Queen Fabiola Children's University Hospital, Brussels, Belgium ††Intestinal Ecosystem, Probiotics, Antibiotics (EA4065), Sorbonne Paris Cité, DHU Risks in Pregnancy, Paris Descartes University, Paris, France.
出版信息
J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):456-63. doi: 10.1097/MPG.0000000000000803.
OBJECTIVES
Amino acid-based formulas (AAFs) are recommended for children with cow's-milk allergy (CMA) failing to respond to extensively hydrolysed formulas (eHFs). We evaluated the effects of a new thickened AAF (TAAF, Novalac), containing a pectin-based thickener, and a reference AAF (RAAF, Neocate) on allergy symptoms and safety, through blood biochemistry analysis and growth.
METHODS
Infants (ages < 18 months) with CMA symptoms failing to respond to eHFs were randomised in a double-blind manner to receive TAAF or RAAF for 3 months. All of the infants were then fed TAAF for 3 additional months. Paediatric visits occurred at 1, 3, and 6 months. Blood samples were collected at inclusion and 3 months.
RESULTS
Results at 1 month were previously described. The 75 infants with proven CMA and eHF intolerance tolerated their allocated formula. At 3 months, the dominant allergic symptom had disappeared in 76.2% of the infants with TAAF and in 51.5% of the infants with RAAF (P = 0.026). The Scoring Atopic Dermatitis Index significantly improved more with TAAF than with RAAF (-27.3 ± 2.3 vs -20.8 ± 2.2, P = 0.048). Of the infants, 92.9% had normal stools (soft or formed consistency) with TAAF vs 75.8% with RAAF (P = 0.051). More infants in TAAF group had better quality of nighttime sleep (P = 0.036) and low frequency of irritability signs (P < 0.001). With both formulas, all of the biochemical parameters were within normal ranges. There were no differences between the 2 groups in any of the anthropometric z scores.
CONCLUSIONS
The new TAAF was tolerated by all of the infants with CMA and intolerance to eHFs. Anthropometric and clinical data showed that both formulas were safe.
目的
对于对深度水解配方奶粉（eHFs）无反应的牛奶蛋白过敏（CMA）儿童，推荐使用氨基酸基配方奶粉（AAFs）。我们通过血液生化分析和生长情况评估了一种新型增稠氨基酸基配方奶粉（TAAF，诺瓦拉克）和一种对照氨基酸基配方奶粉（RAAF，纽康特）对过敏症状和安全性的影响。
方法
对有CMA症状且对eHFs无反应的婴儿（年龄<18个月）进行双盲随机分组，接受TAAF或RAAF喂养3个月。然后所有婴儿再接受TAAF喂养3个月。在第1、3和6个月进行儿科随访。在入组时和3个月时采集血样。
结果
1个月时的结果已在之前描述过。75名确诊为CMA且对eHFs不耐受的婴儿耐受了分配给他们的配方奶粉。在3个月时，使用TAAF的婴儿中76.2%的主要过敏症状消失，使用RAAF的婴儿中这一比例为51.5%（P = 0.026）。与RAAF相比，TAAF使特应性皮炎评分指数改善更显著（-27.3±2.3对-20.8±2.2，P = 0.048）。使用TAAF的婴儿中92.9%大便正常（质地软或成形），而使用RAAF的这一比例为75.8%（P = 0.051）。TAAF组更多婴儿夜间睡眠质量更好（P = 0.036）且烦躁迹象出现频率更低（P<0.001）。使用两种配方奶粉时，所有生化参数均在正常范围内。两组在任何人体测量学z评分上均无差异。
结论
所有CMA且对eHFs不耐受的婴儿都耐受新型TAAF。人体测量学和临床数据表明两种配方奶粉均安全。
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