Safety and efficacy of an olive oil-based triple-chamber bag for parenteral nutrition: a prospective, randomized, multi-center clinical trial in China
| Autor: | Gary P. Zaloga, Yang Xia, Da-Nian Tong, Zhen-Yi Jia, Huanlong Qin, Jun J. Yang |
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| Jazyk: | angličtina |
| Předmět: |
Male
China Fat Emulsions Intravenous Parenteral Nutrition medicine.medical_specialty food.ingredient Anabolism Olive oil-based lipid Medicine (miscellaneous) Clinical nutrition Nutritional outcomes Gastroenterology Soybean oil Procalcitonin law.invention food Randomized controlled trial law Internal medicine medicine Humans Prospective Studies Prospective cohort study Olive Oil Nutrition and Dietetics business.industry Research Soy bean oil-based lipid Middle Aged Soybean Oil Surgery Clinical trial Treatment Outcome Parenteral nutrition Female Infection business |
| Zdroj: | Nutrition Journal |
| ISSN: | 1475-2891 |
| DOI: | 10.1186/s12937-015-0100-6 |
| Popis: | Small studies suggest differences in efficacy and safety exist between olive oil-based (OLIVE) and soybean oil-based (SOYBEAN) parenteral nutrition regimens in hospitalized adult patients. This large, prospective, randomized (1:1), open-label, multi-center, noninferiority study compared the delivery, efficacy, and safety of OLIVE (N = 226) with SOYBEAN (N = 232) in Chinese adults (≥18 years) admitted to a surgical service for whom parenteral nutrition was required. Treatments were administered for a minimum of 5 days up to 14 days (to achieve approximately 25 kcal/kg/day, 0.9 g/kg/day amino acids, 0.8 g/kg/day lipid). Impact of treatment on anabolic/catabolic and serum inflammatory, chemistry, and hematological markers, safety, and ease of use were assessed. The primary efficacy variable was serum prealbumin level at Day 5. OLIVE (n = 219) was not inferior to SOYBEAN (n = 224) based on the prealbumin least square geometric mean [LSGM] ratio [95 % CI] 1.12 [1.06, 1.19]; P = 0.002), improved the anabolic/catabolic status of patients enrolled in the study, and was well tolerated compared with SOYBEAN. Improved anabolic status was supported by significantly higher levels of prealbumin at Day 5, albumin at Day 5 and IGF-1 at Day 14 in the OLIVE group, while catabolism was similar between groups. C-reactive protein, intercellular adhesion molecule-1, procalcitonin, and oxidation were similar in each group, but infections were significantly lower with OLIVE (3.6 % versus 10.4 %; P |
| Databáze: | OpenAIRE |
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