口服补充新型肠内营养的多中心临床研究

Muti-center clinical researches of new oral enteral nutrition in patients

目的通过多中心随机对照的临床试验研究,探讨以胶原蛋白为基质的肠内营养制剂与标准型肠内营养制剂对患者营养状况的影响,判断新型肠内营养制剂的临床应用效果。方法本研究共6家医疗单位共同参与,共收集74例,随机分为对照组(标准肠内营养)及干预组(以胶原蛋白为基质的肠内营养),口服补充1673.6k J(400kcal)/d,持续21天,检测研究开始前后患者体格指标、营养相关指标及安全性指标。结果组内比较显示两组患者食用肠内营养制剂后营养风险筛查NRS 2002评分显著下降(P<0.025),血白蛋白较食用前显著增高(P<0.025),组间比较显示对照组与干预组体格指标、营养相关指标及安全性指标均无统计学差异(P>0.025)。结论新型肠内营养制剂与标准型肠内营养制剂均可以有效改善患者的营养状况。

Objective The aim of this study was to understand nutritional status in hospitalized patients with collagen-based medical foods and standard enteral nutrition by muti-center clinical researches, and provide scientiifc reference for medical foods. Methods 6 units joint in this research. we collected 74 patients, patients were divided into two groups ( group with standard enteral nutrition and group with collagen-based medical foods) according to random number table, add 1673.6kJ(400 kcal)/d in 21 days, detect medical indicators ,laboratory examination and gastrointestinal reaction before and after the research.Results NRS2002 has signiifcantly decreased and ALB has signiifcantly increased after using enteral nutrition (P<0.025). Nutritional status, medical indi-cators, laboratory examination and gastrointestinal reaction have no difference in intervention group and control group(P>0.025). Conclusions The new type of enteral nutrition preparations and standard enteral nutrition preparations can effectively improve the nutritional status of patients.