深度水解蛋白配方乳对早产儿喂养和生长影响的多中心临床对照研究

Effects of extensively hydrolyzed protein formula on feeding and growth in preterm infants：a multicenter controlled clinical study

摘要:

目的 通过多中心临床对照研究，观察深度水解蛋白配方乳（eHF）对早产儿喂养和生长的影响。方法 随机选取2012 年2 月至2013 年12 月入住国内8 家三甲医院的早产儿，根据喂养方案分组：（1）胎龄<32 周的早产儿，出生后用 eHF 喂养至生后10~14 d，后改为标准早产儿配方乳（SPF）喂养至出院；（2）胎龄32~34 周的早产儿，出生后用SPF 喂养，如生后6~8 d 有喂养不耐受，改用eHF 喂养7~14 d，再转为SPF 喂养至出院；（3）设立与上述胎龄相应的全程SPF 对照组。记录临床资料，比较各组的喂养情况、体格生长、血生化指标和主要并发症。结果 纳入研究的早产儿共328 例。胎龄<32 周eHF 观察组胎粪排空时间短于SPF 喂养的对照组（P<0.05），且生后第1、2 周血清总胆红素水平低于对照组（P<0.05）；观察组在肠内营养达基础热卡（每日50 kcal/kg）日龄、部分肠外营养时间、平均住院时间、出院时纠正胎龄等均大于对照组（P<0.05）；但出院时宫外生长迟缓（EUGR）的发生率组间比较差异无统计学意义（P>0.05）。胎龄32~34 周的观察组发生喂养不耐受后用eHF，生后第2 周血清总胆红素水平低于其相应的对照组（P<0.05）；而肠内营养达基础热卡日龄、部分肠外营养时间大于对照组（P<0.05）；出院时EUGR 的发生率与对照组比较差异无统计学意义（P>0.05）。结论 eHF 可促进早产儿胃肠动力功能、加速胆红素代谢和排泄，且未增加EUGR 的发生。

Abstract:

Objective To study the effects of extensively hydrolyzed protein formula (eHF) on the feeding and growth in preterm infants through a multicenter controlled clinical study. Methods Preterm infants admitted to eight upper first-class hospitals in China between February 2012 and December 2013 were randomly selected. They were divided into two observation groups and two control groups. The first observation group consisted of preterm infants with a gestational age of <32 weeks, who were fed with eHF for 10-14 days after birth and then with standard preterm formula (SPF) until discharge. The second observation group consisted of preterm infants with a gestational age of 32-34 weeks, who were fed with SPF after birth, but were switched to eHF (7-14 days) if suffering feeding intolerance at 6-8 days after birth. The two control groups with corresponding gestational ages kept to be fed with SPF after birth. Clinical data were recorded to compare feeding condition, physical growth, blood biochemical indices, and major complications between different groups. Results A total of 328 preterm infants were enrolled. Preterm infants with a gestational age of <32 weeks in the observation group had a significantly shorter meconium evacuation time than in the corresponding control group (P<0.05). They also had significantly lower levels of serum total bilirubin at weeks 1 and 2 after birth compared with the control group (P<0.05). The observation group needed more time in reaching enteral nutrition (EN) basic energy uptake of 50 kcal/(kg·d), partial parenteral nutrition (PPN), hospitalization, and corrected gestational age at discharge compared with the controlled infants (P<0.05). There was no difference in the incidence of extrauterine growth retardation (EUGR) at discharge between the two groups (P>0.05). Preterm infants with a gestational age of 32-34 weeks in the observation group had significantly lower serum total bilirubin levels at 2 weeks after birth compared with the corresponding control group (P<0.05). They required more time in achieving EN basic energy and PPN than in the control group (P<0.05). There was no difference in the incidence of EUGR at discharge between the two groups (P>0.05). Conclusions For preterm infants, eHF can improve gastrointestinal motility, accelerate bilirubin metabolism and excretion and does not increase the incidence of EUGR.