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目的通过多中心随机对照的临床试验研究,比较以胶原蛋白为基质的新型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,以了解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91例,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),管饲补充104.6~125.5 kJ(25~30kcal)/(kg·d),共7d,检测研究开始前后患者体格指标、营养相关指标、安全性指标等。结果组内比较显示两组患者在管饲两种不同的肠内营养制剂后营养风险筛查评分(NRS2002)较管饲前均有所降低(均P<0.025);组间差值比较显示患者营养状况、营养风险筛查(NRS2002)评分、胃肠道不良反应在两组间均无统计学差异(均p>0.025)。结论以胶原蛋白为基础经氨基酸模式优化后的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,有助于促进患者的疾病预后。
Objective To compare the clinical effects of new enteral nutrition preparations and standard enteral nutrition preparations on the nutritional status of patients through a multicenter randomized controlled clinical trial to find out the clinical application of new enteral nutrition preparations. Methods A total of 6 medical units participated in the study. A total of 91 patients were enrolled in the study. The patients were divided into control group (standard enteral nutrition) and intervention group (enteral nutrition with collagen matrix), while tube feeding was supplemented with 104.6-125.5 kJ ~ 30kcal) / (kg · d) for a total of 7 days before and after the start of the study to test the patient’s physical, nutritional, and safety indicators. Results In-group comparison showed that both groups had lower nutritional risk screening score (NRS2002) after gavage of two different enteral nutrition preparations than those before gavage (all P <0.025). The differences between groups showed that patients Nutritional status, nutritional risk screening (NRS2002) score, gastrointestinal adverse reactions in both groups were not statistically different (all p> 0.025). Conclusions Enteral nutrition preparations and standard enteral nutrition preparations optimized by amino acid model based on collagen can effectively improve the nutritional status of patients and promote the prognosis of patients.