Brown Britta, Roehl Kelly, Betz Melanie
Hennepin County Medical Center, Minneapolis, Minnesota
Rush University Medical Center, Chicago, Illinois.
Nutr Clin Pract. 2015 Feb;30(1):72-85. doi: 10.1177/0884533614561791. Epub 2014 Dec 16.
Many new enteral nutrition (EN) formulas have been created over the past several decades with a variety of intended uses. Although each is intended to promote improved outcomes, research is often unclear and, in many cases, conflicting. It is important to note that EN products are considered medical foods by the U.S. Food and Drug Administration and therefore do not have to complete premarket review or approval and are not regulated to the same extent as pharmaceuticals. While standard EN formulas are designed to meet the basic macro- and micronutrient requirements of individuals who cannot meet nutrition needs orally, specialty EN products have been developed to exhibit pharmacologic properties, such as immune-enhancing formulas containing arginine, glutamine, nucleotides, and ω-3 fatty acids. With the vast number of products available, rising costs of healthcare, and the drive toward evidence-based practice, it is imperative that clinicians carefully consider research regarding use of specialty formulas, paying close attention to the quality, patient population, clinical end points, and cost to patient and/or facility.
在过去几十年里,人们研发出了许多具有多种预期用途的新型肠内营养(EN)配方产品。尽管每种产品都旨在促进更好的治疗效果,但相关研究往往并不明确,而且在很多情况下相互矛盾。需要注意的是,美国食品药品监督管理局将EN产品视为医疗食品,因此无需完成上市前审查或批准,并且其监管程度与药品不同。标准的EN配方旨在满足无法通过口服满足营养需求的个体的基本宏量和微量营养素需求,而特殊的EN产品则被开发出来以展现药理特性,例如含有精氨酸、谷氨酰胺、核苷酸和ω-3脂肪酸的免疫增强配方。鉴于有大量产品可供选择、医疗保健成本不断上升以及循证医学实践的推动,临床医生必须仔细考虑有关特殊配方使用的研究,密切关注质量、患者群体、临床终点以及对患者和/或医疗机构的成本。