论文部分内容阅读
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。
Objective To evaluate the efficacy and safety of enteral nutrition powder (AA-PA) in the treatment of infants with food protein allergy. Methods From June 2008 to August 2010, Beijing Children’s Hospital Affiliated to Capital Medical University as the main research unit, the Second Affiliated Hospital of Kunming Medical College, the Second Affiliated Hospital of Wenzhou Medical College, Wuxi City People’s Hospital of Jiangsu Province, Shanghai Jiao Tong University School of Medicine Affiliated Xinhua Hospital, Peking University Third Hospital, Hunan Provincial People’s Hospital, First Hospital of Jilin University and Shengjing Hospital Affiliated to China Medical University using prospective, randomized, blinded, controlled, multicenter clinical research methods, the inclusion of food protein Allergy and exclusion of 248 soy protein-specific IgE-positive children, of which 124 cases were given amino acid formula enteral nutrition powder (AA-PA), 124 cases were given soy protein formula nutritional powder to assess the treatment before and after treatment 4,8,8, At 12 weeks, the body weight, height, food allergy clinical manifestations and adverse events, side effects; serum total protein and albumin before and 12 weeks after treatment. Results Intent-to-Treat (ITT) analysis showed that both AA-PA and soy protein groups could meet the normal growth of food allergy infants after 12 weeks, all of which could prevent the occurrence of food allergy. The body weight of AA-PA group (1.22 ± 0.73) kg at week 8 was significantly higher than that of soy protein group (1.02 ± 0.65) kg (P <0.05) Soy protein group (1.39 ± 0.87) kg, the difference between the two groups was statistically significant (P <0.05); two groups of children increased height, clinical symptoms and signs improved, plasma total protein and albumin was no significant difference (P> 0.05 ). Both groups of adverse events were common respiratory and digestive diseases, AA-PA group incidence of disease in children was 44.35%, soybean protein group was 45.16%, the difference was not statistically significant (P> 0.05). Conclusion AA-PA can meet the needs of normal growth and development of food-protein allergy infants and young children, and is superior to soy protein formula powder in terms of body weight gain. AA-PA can alleviate the allergic reaction of milk or food protein in infants and improve the clinical manifestations of allergy. Good sex.