Abstract:

Objective    To investigate the efficacy and safety of enteral nutritional powder （AA-PA， an amino acid-based formula） therapy in treatment of the infants with food protein allergy.Methods    The prospective， blind， controlled， multi-center trial was performed.Two hundred and forty-eight infants with cow’s milk allergy or food protein allergy，with exclusion of positive diagnostic serum-specific IgE values to soy protein were randomized either to be treated with an amino acid-based formula （n = 124） or soy protein-based formula （n = 124） for 12 weeks. The weight， height， allergic clinical manifestations， adverse events and adverse reactions were estimated in pre-treatment and 4th ，8th and12th week during treatment respectively. The serum total protein and albumin were measured in pre-treatment and 12th week during treatment respectively.Results    The feeding of enteral nutritional powder satisfied the need of growth and improved significant clinical manifestations for food protein allergy in two groups. In amino acid-based formula group there was a significantly increase in the weight，compared with the soy protein-based formula group，the different value between week 4 and base weight：0.65kg ± 0.45 kg vs 0.61 kg ± 0.47 kg， P = 0.6720； between week 8 and base weight：1.22 kg ± 0.73 kg vs 1.02 kg ± 0.65 kg， P = 0.0368； between week 12 and base weight：1.74 kg ± 0.91 kg vs 1.39 kg ± 0.87 kg， P = 0.0022. The height， clinical manifestations， serum total protein and albumin during observation were similar in both groups. The adverse event rate was 44.35% in amino acid-based formula group and 45.16% in soy protein-based formula group， observed almost in respiratory and digestive system. No statistical significance was noticed in all safety parameters in amino acid-based formula group compared with soy protein-based formula group.Conclusion    The amino acid-based formula proves to be an effective substitute formula for the infants with cow’s milk allergy or food protein allergy， and it is superior to soy protein-based formula in weight gain and safety and is well tolerated.

Key words: enteral nutritional powder（AA-PA）, food protein allergy, infancy, clinical trial

摘要：

目的    评价肠内营养粉剂（AA-PA）治疗食物蛋白过敏婴儿的有效性及安全性。方法    2008年6月至2010年8月首都医科大学附属北京儿童医院为主要研究单位，联合昆明医学院第二附属医院、温州医学院附属第二医院、江苏省无锡市人民医院、上海交通大学医学院附属新华医院、北京大学第三医院、湖南省人民医院、吉林大学第一医院和中国医科大学附属盛京医院采用前瞻、随机、盲法、对照、多中心临床研究方法，共入组食物蛋白过敏并排除大豆蛋白特异性IgE阳性患儿248例，其中124例给予氨基酸配方肠内营养粉剂（AA-PA），124例给予大豆蛋白配方营养粉剂，评估治疗前及治疗后第4、8、12周患儿体重、身高、食物蛋白过敏临床表现和不良事件、副反应；治疗前及治疗后12周血清总蛋白、白蛋白变化。结果    意向性治疗（ITT）分析结果显示，12周后AA-PA组与大豆蛋白组均能满足食物蛋白过敏婴儿正常生长需要，均能避免婴儿发生食物（含牛奶）蛋白过敏。第8周时AA-PA组体重增加（1.22 ± 0.73）kg显著优于大豆蛋白组（1.02 ± 0.65） kg（P＜0.05）；第12周AA-PA组体重增加（1.74 ± 0.91）kg，大豆蛋白组（1.39 ± 0.87）kg，两组差异有统计学意义（P＜0.05）；两组儿童身高增长、临床症状和体征改善、血浆总蛋白和白蛋白差异无统计学意义（P＞0.05）。两组不良事件均以呼吸系统和消化系统疾病常见，AA-PA组儿童疾病发生率为44.35%，大豆蛋白组为45.16%，差异无统计学意义（P＞0.05）。结论  AA-PA可满足食物蛋白过敏婴幼儿正常生长发育需要，对体重增加方面优于大豆蛋白配方粉剂；AA-PA能缓解婴儿牛奶或食物蛋白过敏且改善过敏的临床表现；临床应用安全、耐受性好。

关键词: 氨基酸配方肠内营养粉剂, 食物蛋白过敏, 婴儿, 临床研究