FDA/ASPEN公开研讨会论文集：静脉脂肪乳剂产品临床试验设计
JPEN J Parenter Enteral Nutr. 2015;39(7):768-86.
Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013.
Teitelbaum DH, Guenter P, Griebel D, Abrams SA, Bark S, Baker M, Berry KL, Bistrian BR, Brenna JT, Bonnot D, Carpentier YA, Deckelbaum RJ, Hise M, Koletzko B, Mirtallo JM, Mulberg AE, O'Reilly RC, Shaffer J, von Kleist E, Zaloga GP, Ziegler TR.
C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, Michigan.
American Society for Parenteral and Enteral Nutrition, Silver Spring, Maryland.
Division of Gastroenterology and Inborn Error Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Department of Pediatrics, Sections of Neonatology and USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas.
Department of Surgery, Karolinska Institute, Stockholm, Sweden, and Department of Surgery, Visby Hospital, Visby, Sweden.
Hospira, Inc, Chicago, Illinois.
Harvard Medical School, Clinical Nutrition, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Division of Nutritional Sciences, Cornell University, Ithaca, New York.
Scientific Affairs, Business Unit, Parenteral Nutrition & Colloids, Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany.
Free University of Brussels (Université Libre de Bruxelles) and Lipid Nutrition Center, Brussels, Belgium.
Department of Pediatrics and Epidemiology, Institute of Human Nutrition, Columbia University Medical Center, New York, New York.
Baxter Healthcare, Deerfield, Illinois.
Dr von Hauner Children's Hospital, University of Munich Medical Centre, Germany.
The Ohio State University, College of Pharmacy, Ohio State University, Columbus, Ohio.
University of Colorado, Boulder, Colorado.
Intestinal Failure Unit, Salford Royal Hospital, University of Manchester, United Kingdom.
Hospital Care Division, B. Braun Melsungen AG, Melsungen, Germany.
Division of Endocrinology, Metabolism and Lipids and Emory Center for Clinical and Molecular Nutrition, Emory University Hospital, Atlanta, Georgia.
The development of intravenous fat emulsion (IVFE) is the culmination of physiological, biochemical, nutritional, and medical scientific advancements. IVFEs have the ability to deliver critical nutritional substrates to the patient. Recent literature purports that they may also play roles in modulation of immune functionality and pulmonary physiology, but data supporting these potential benefits are limited. While soybean-based IVFEs have comprised the dominant fat in U.S. markets, a number of other novel IVFEs may prove to optimize the care of children and adults in both hospitalized and home settings. The October 2013 U.S. Food and Drug Administration (FDA)/American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Public Workshop brought together scientists, researchers, and clinical experts to present updated clinical perspectives of IVFEs, including historical development, current state of usage throughout the world, and considerations for the regulatory approval of new IVFEs in the United States.
KEYWORDS: fatty acids; lipids; nutrition; research and diseases
PMID: 25475623
DOI: 10.1177/0148607114560825