乳蛋白部分水解配方奶粉在过敏高风险新生儿的临床研究

Clinical trial study of partially hydrolyzed formulas in infants with high risk of allergy

目的研究乳蛋白部分水解配方奶粉(pHFs)对过敏高风险新生儿0~3个月体格发育和过敏反应的影响。方法前瞻性纳入2019年1-9月在天津市和沈阳市各级妇产医院和综合性医院产科出生的过敏高风险遗传背景的新生儿,按照家属意愿分为普通配方奶喂养组(A组)、母乳喂养组(B组)和pHFs组(C组),并在4周和12周随访其体格发育指标和过敏反应,分析3种喂养方式间体格发育和过敏反应的差异。结果共纳入806例过敏高风险遗传背景的新生儿,其中A组84例,B组362例,C组360例。三组新生儿0周、4周、12周体重、身长、头围比较,差异均无统计学意义(P>0.05)。12周内共有196例新生儿发生过敏反应,其中A组发生率(35.7%)显著高于B组(26.8%)和C组(19.2%)(P=0.0021)。单变量Logistic回归分析结果显示,C组发生过敏反应的风险是A组的0.43倍(OR=0.43,95%CI:0.25~0.72,P=0.0013)。校正性别、分娩方式、胎龄、出生体重和母亲年龄因素后,乳蛋白部分水解配方奶粉和母乳喂养发生过敏反应的风险仅为普通配方奶喂养的0.28和0.26(OR=0.28,95%CI:0.12~0.66,P=0.0038;OR=0.26,95%CI:0.11~0.62,P=0.0026)。结论乳蛋白部分水解配方奶粉可以满足过敏高风险遗传背景的新生儿0~3个月的体格发育需求,降低过敏反应的发生风险。

Objective To observe the effects of partially hydrolyzed formulas(pHFs)on the physical development and allergic reaction of infants with high risk of allergy aged from 0 to 3 months.Methods Infants with high-risk genetic allergy background born in maternity hospitals and maternity departments in general hospitals from Shenyang and Tianjin between January to September,2019 were included and divided into general formula feeding group(group A),breast-feeding group(group B)and pHF-feeding group(group C)according to their families’wishes.Physical growth and allergic reaction were followed up in 4 weeks and 12 weeks and the differences in them were analyzed.Results A total of 806 infants were included,including 84 infants in group A,362 infants in group B and 360 infants in group C.Weight,body length or head circumference had no significant differences among the three groups at 0 week,4 weeks or 12 weeks(P>0.05).Totally,196 infants had allergic reactions within 12 weeks,among which group A(35.7%)was significantly higher than group B(26.8%)and group C(19.2%)(P=0.0021).Univariate logistic regression analysis showed that the risk of anaphylaxis in group C was 0.43 times than that of group A(OR=0.43,95%CI:0.25~0.72,P=0.0013),while the risk of allergic reaction was only 0.28 and 0.26 for pHF(OR=0.28,95%CI:0.12~0.66,P=0.0038)and breast-feeding(OR=0.26,95%CI:0.11~0.62,P=0.0026)after adjusting for gender,methods of delivery,gestational age,birth weight,and maternal age.Conclusion pHF-feeding can meet the physical development needs of infants and reduce the risk of allergic reaction aged between 0 to 3 months.