Abstract
BackgroundA lipid emulsion composed of soybean oil (long-chain triglycerides, LCT), medium-chain triglycerides (MCT) and n-3 poly-unsaturated fatty acids (PUFAs) was evaluated for immune-modulation efficacy, safety, and tolerance in patients undergoing major surgery for gastric and colorectal cancer.MethodsIn a prospective, randomized, double-blind study, 99 patients with gastric and colorectal cancer receiving elective surgery were recruited and randomly assigned to either the study group, receiving the n-3 PUFAs enriched intravenous fat emulsion (IVFE), or the control group, receiving a lipid emulsion comprised of soybean oil and MCTs (0.8 – 1.5 g · kg-1 · day-1) as part of total parenteral nutrition (TPN) regimen from surgery (day -1) up to post-operative day 7. Safety and efficacy parameters were assessed on day -1 and post-operative visits on day 1, 3, and 7. Adverse events were documented daily and compared between the groups.ResultsPro-inflammatory markers, laboratory parameters, and adverse events did not differ prominently between the 2 groups, with the exception of net changes (day 7 minus day -1) of free fatty acids (FFAs), triglyceride, and high-density lipoprotein (HDL). Net decrease of FFAs was remarkably higher in the study group, while the net increase of triglyceride and decrease of HDL was significantly lower.ConclusionsThe n-3 PUFA-enriched IVFE showed improvements in lipid metabolism. In respect of efficacy, safety and tolerance both IVFE were comparable. In patients with severe stress, there is an inflammation-attenuating effect of n-3 PUFAs. Further, adequately powered clinical trials will be necessary to address this question in postsurgical GI cancer patients.Trial registrationUS ClinicalTrials.gov NCT00798447.
Highlights
A lipid emulsion composed of soybean oil, medium-chain triglycerides (MCT) and n-3 poly-unsaturated fatty acids (PUFAs) was evaluated for immune-modulation efficacy, safety, and tolerance in patients undergoing major surgery for gastric and colorectal cancer
Studies undertaken with n-3 PUFAs containing parenteral lipid emulsions in patients undergoing major abdominal surgery [10,11], in patients undergoing surgery for aortic aneurism repair [12], and in patients with acute respiratory distress syndrome (ARDS) [13,14], have proven clinically to reduce length of post-operative hospital stay, frequency of postoperative complications, as well as to lower the levels of pro-inflammatory factors such as leukotriene B4 (LTB4) [14] and Interleukin 6 (IL-6) [15]
analysis of variance (ANOVA) incorporating center effect and Cochran-Mantel-Haenszel test stratified by center are applied to replace 2-sample t-test and Fisher’s exact test
Summary
A lipid emulsion composed of soybean oil (long-chain triglycerides, LCT), medium-chain triglycerides (MCT) and n-3 poly-unsaturated fatty acids (PUFAs) was evaluated for immune-modulation efficacy, safety, and tolerance in patients undergoing major surgery for gastric and colorectal cancer. The nutritional regimen will usually be composed to provide the basic requirements of patients and should contain amino acids, glucose and lipids as well as micronutrients and electrolytes. In addition to their role in providing energy, omega 3 polyunsaturated fatty acids (n-3 PUFAs) have additional features, such as the modulation of the metabolic and inflammatory responses that are of benefit to malnourished patients receiving surgery. N-3 PUFAs are preferentially incorporated into cell membrane phospholipids, influence secondary messenger synthesis and modulate the expression of certain adhesion molecules at the surface of endothelial cells, monocytes and lymphocytes [2,3] They have been shown to influence cell membrane fluidity and permeability and to modify the cell membrane receptors and enzymes activity [4,5]. Studies undertaken with n-3 PUFAs containing parenteral lipid emulsions in patients undergoing major abdominal surgery [10,11], in patients undergoing surgery for aortic aneurism repair [12], and in patients with acute respiratory distress syndrome (ARDS) [13,14], have proven clinically to reduce length of post-operative hospital stay, frequency of postoperative complications, as well as to lower the levels of pro-inflammatory factors such as leukotriene B4 (LTB4) [14] and Interleukin 6 (IL-6) [15]
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