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Randomized Controlled Trial Comparative Study
A double-blind randomized study comparing the efficacy and safety of a composite vs a conventional intravenous fat emulsion in postsurgical gastrointestinal tumor patients.
- Cheng-Jen Ma, Li-Chu Sun, Fang-Ming Chen, Chien-Yu Lu, Ying-Ling Shih, Hsiang-Lin Tsai, Jui-Fen Chuang, and Jaw-Yuan Wang.
- Division of Gastrointestinal and General Surgery, Department of Surgery, Kaohsiung Medical University, Kaohsiung, Taiwan.
- Nutr Clin Pract. 2012 Jun 1;27(3):410-5.
BackgroundComposite intravenous fat emulsion, a fat emulsion composed of soybean oil, medium-chain triglycerides (MCT), olive oil, and fish oil, was evaluated for metabolic efficacy, immune modulation, clinical efficacy, safety, and tolerance in surgical gastrointestinal (GI) tumor patients.MethodsIn a prospective, randomized, double-blind study, 40 patients were randomized after elective digestive surgery to receive isonitrogenous, isoenergetic parenteral nutrition for 5 days postoperatively with either composite 20% IVFE (composed of soybean, MCT, olive, and fish oils) or a conventional long-chain triglyceride (LCT)/MCT 20% IVFE (LCT/MCT IVFE); IVFE was dosed at 1-2 g/kg body weight. Safety and efficacy parameters were assessed on operation day (day 0) and at the end of study (day 6). Adverse events were documented daily and clinical outcomes were recorded and compared between the groups.ResultsMetabolic parameters, laboratory parameters, proinflammatory cytokine levels, adverse events, and clinical outcomes did not differ between the 2 groups, with the exception that postoperative low-density lipoprotein levels decreased significantly in the composite IVFE group (93.2 ± 24.3 vs 110.5 ± 26.4 mg/dL, P = .038).Conclusionscomposite IVFE was comparable with conventional LCT/MCT IVFE in efficacy, safety, tolerance, and clinical outcomes in surgical GI tumor patients.
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