| Lipid emulsions have been used in routine clinical practice for more than 40 years. Intralipid,the first well tolerated lipid emulsion, is still the most commonly used lipid emulsion worldwide containing long-chain triglycerides (LCT) with a fatty acid chain length of 16-20 carbon atoms (long-chain fatty acids,LCFA).Suggested disavantages of LCT are their slow elimination from the bloodstream, the relatively high content of n-6 polyunsaturated fatty acids, in particular linoleic acid, a relatively high rate of reesterification, and storage of triglycerides in various tissues. It has also been suggested that LCT may interfere with the immune system, but this has not been demonstrate in clinical practice.There is an alternative concept to conventional soybean oil emulsions with a physical mixture of medium-chain triglycerides(MCT) and LCT or as structured triglycerides. MCT are triglycerides composed predominantly of fatty acids with 8 and 10 carbon atoms (medium-chain fatty acids, MCFA). MCT have been reported to be metabolised faster than LCT, with little or no storage of MCFA in tissures, to be oxidised partly independent of carnitine and to entail less effect on the reticuloendothelial function. Consequently, in clinical practice physical mixtures of MCT/LCT emulsions have been available on the market since the'80s and structured triclycerides since the'90s.For a long time, lipid supply in parenteral nutrition was considered exclusively as a means of providing energy and of preventing or correcting essential fatty acid deficiency. More recently, research on the importance of n-6 and n-3 fatty acids for inflammatory response led to a search for new types of lipid emulsions, in particular fish oil, as a valuable source of the very long-chain n-3 fatty acid eicosapentaenoic(EPA) and docosahexaenoic acid(DHA).this was the starting point for the development of SMOFlipid.Objective:To assess the effects of SMOF 20% on fatty acid and inflammatory mediators in parenteral nutrition following major abdominal surgery, compared with Intralipid20%.and to achieve the information about the efficacy and safety of SMOFlipid 20%. Methods:In a prospective, double-blind study, postoperative patients were randomized to receive isonitrogenous, isoenergetic total parenteral nutrition over 5 postoperative days including either SMOFlipid 20% or Intralipid 20% as lipid source (1.5g·kg-1·day-1) and written informed consent The dose of lipids and glucose could each be optionally reduced to 50% on the first post-operative day. Electrolytes trace elements and vitamins can be administered as required. All patients will receive the treatment of ALL IN ONE (AIO) nutrition injection containing the study drug (investigational product or control product), glucose and amino acids. Nutrition treatment should continue up to d5 post-operatively.Patients were excluded with:hyperlipidemia, diabetes mellitus, overweight, hepatic or renal insufficiency, acute or chronic heart insufficiency,severe hemorrhagic diathesis, and pregnancy and/or lactation. Weight, BMI and Homeostasis were recorded on the morning of pre-operation and the sixth day after operation. Blood sample were drawn for determination of serum lipids, albumin, total protein, prealbumin, transferrin, renal/hepatic functionsa, CD4/CD8, HLA-DR, fatty acid pattern in plasma phospholipids and inflammatory mediators (LTB5,LTB4,TXB3,TXB2,IL-1,IL-2,IL-6) on the morning of pre-operation, the first, fourth and sixth day after operation. All data were presented as the mean±SD. And the analysis were performed with SPSS 17.0 for windows.Results:1.Free fatty acids(FFA)The level of LA in group SMOF was decreased and group Intralipid was increased compared with the 1st post-operative day, there was significant difference in two groups (P<0.05);The level ofα-LA in group SMOF was significantly decreased compared with group Intralipid (P<0.05);The level of AA in group SMOF was significantly decreased compared with group Intralipid (P<0.05); The level of EPA in group SMOF were increased and group Intralipid was decreased compared with the 1st post-operative day, there was significant difference in two groups (P<0.05);The level of DHA in group SMOF were increased and group Intralipid was decreased compared with the 1st post-operative day, there was significant difference in two groups (P<0.05);2.CytokineThe level of LTB5/LTB4 in group SMOF was increased and group Intralipid was decreased compared with the 1st post-operative day, there was significant difference in two groups (P<0.05);The level of TXB3/TXB2 in group SMOF was increased and group Intralipid was decreased compared with the 1st post-operative day, there was significant difference in two groups (P<0.05);The level of TL-2 in group SMOF were decreased compared with the 1st post-operative day, there was significant difference in two groups (P<0.05);The level of IL-1 and IL-6 in group SMOF were decreased compared with the 1st post-operative day, but there was no significant different in two groups (P>0.05).3. coagulatic functionThe coagulatic function in two groups were no significant difference compared with pre-operative day (P>0.05).4. hepatic & renal functionThe level of ALT, AST andγ-GT in two groups were increased compared with the 1st post-operative day, but there was no significant difference in two groups (P>0.05);The level of BUN and Scr in two groups were increased compared with the 1st post-operative day, but there was no significant difference in two groups (P>0.05).5.weight,BMIThe level of weight and BMI in two groups were decreased compared with the 1st post-operative day, but there was no significant difference in two groups (P>0.05). 6. ALB,TF&PAThe level of ALB and TF in two groups were decreased compared with the 1st post-operative day, but there was no significant difference in two groups (P>0.05);The level of PA in group SMOF was decreased and group Intralipid was increased compared with the 1st post-operative day, but there was no significant difference in two groups (P>0.05).7.serum lipidsThe level of TG in two groups were increased compared with the 1st post-operative day, but there was no significant difference in two groups (P>0.05);The level of TC in group SMOF was increased and group Intralipid was decreased compared with the 1st post-operative day, but there was no significant difference in two groups (P>0.05);The level of HDL-C in two groups were decreased compared with the 1st post-operative day, but there was no significant difference in two groups (P>0.05);The level of LDL-C in two groups were increased compared with the 1st post-operative day, but there was no significant difference in two groups (P>0.05).8.CD4/CD8,HLA-DRThe level of CD4/CD8 in two groups were increased compared with the 1st post-operative day, but there was no significant-difference in two groups(P>0.05);The level of HLA-DR in two groups were increased compared with the 1st post-operative day, but there was no significant difference in two groups (P>0.05).Conclusions:1. Treatment with SMOFlipid is well tolerated and modulates FA and inflammatory mediators suggesting favourable anti-inflammatory effects.2. SMOFlipid is clinically safe and well tolerated in postoperative patients. There are indications that SMOFlipid may be associated with a better liver tolerance and beneficial immunomodulatory effects. |
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