乳糖酶添加剂对早产儿乳糖不耐受有效性和安全性的前瞻性随机对照研究

Efficacy and safety of lactase additive in preterm infants with lactose intolerance: a prospective randomized controlled trial

摘要:

目的 探讨乳糖酶添加剂对改善早产儿乳糖不耐受的有效性和安全性。方法 选取上海交通大学医学院附属新华医院2018年1月至2019年12月收治的有乳糖不耐受症状的早产儿60例纳入研究，随机分为乳糖酶治疗组和对照组，每组30例。乳糖酶治疗组给予乳糖酶添加剂4滴（180 mg）加入早产儿配方奶或母乳中；对照组给予安慰剂，同时予以益生菌（双歧杆菌三联活菌散，喂养后半小时口服，每日2次，每次1 g）和腹部按摩（喂养后1 h脐周顺时针轻柔按摩15 min，每日3次）。在干预后第1周末和第2周末比较两组患儿粪便pH值、粪便还原糖、生长发育、乳糖不耐受症状和实验室指标等情况。结果 乳糖酶治疗组29例、对照组26例完成整个试验。干预后第1周末，乳糖酶治疗组每日吐奶次数和胃潴留量均低于对照组（P < 0.05）；粪便pH值 > 5.0的比例高于对照组（P < 0.05）。干预后第2周末，乳糖酶治疗组每日吐奶次数和24 h腹围差低于对照组（P < 0.05），无胃潴留患儿比例、粪便pH值 > 5.0的比例及粪便还原糖阴性比例均高于对照组（P < 0.05）。研究过程中两组均未发现乳糖酶添加剂或益生菌相关不良反应。结论 乳糖酶添加剂能安全有效地改善早产儿乳糖不耐受引起的临床症状。

Abstract:

Objective To study the efficacy and safety of lactase additive in improving lactose intolerance in preterm infants. Methods A total of 60 preterm infants with lactose intolerance who were admitted to the Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from January 2018 to December 2019 were randomly divided into a lactase treatment group and a control group, with 30 infants in each group. The infants in the lactase treatment group were given 4 drops of lactase additive (180 mg) added into preterm formula or breast milk, and those in the control group were given placebo, oral administration of probiotics (live combined Bifidobacterium, Lactobacillus and Enterococcus powder) at half an hour after feeding (1 g each time, twice a day), and clockwise abdominal massage around the belly button at 1 hour after feeding for 15 minutes each time, 3 times a day. Fecal pH, fecal reducing sugar, growth indicators, symptoms of lactose intolerance, and laboratory markers were measured at the end of the first and second weeks after intervention. Results Finally 29 infants in the lactase treatment group and 26 infants in the control group completed the trial. At the end of the first week after intervention, compared with the control group, the lactase treatment group had significantly lower frequency of daily milk vomiting and gastric retention amount (P < 0.05) and a significantly higher proportion of infants with fecal pH > 5.0 (P < 0.05). At the end of the second week after intervention, compared with the control group, the lactase treatment group had significantly lower frequency of daily milk vomiting and 24-hour abdominal circumference difference (P < 0.05) and a significantly higher proportion of infants with the absence of gastric retention, fecal pH > 5.0, or negative reducing sugar in feces (P < 0.05). No adverse reactions associated with the lactase additive or probiotics were observed during the trial. Conclusions Lactase additive can safely and effectively improve the clinical symptoms caused by lactose intolerance in preterm infants.