Surgery News - September 2007 - (Page 18) 18 PEDIATRIC SURGERY NEWS • S E P T E M B E R 2 0 0 7 Fish Oil Emulsion Improves Cholestasis in Infants BY MITCHEL L. ZOLER Else vier Global Medical Ne ws O R L A N D O — Substituting an omega-3, fish oil–based emulsion for the standard omega-6, soy bean–based emulsion in parenteral nutrition formula led to faster reversal of cholestasis in an uncontrolled series of 18 infants. Omegaven, a fish oil-based, omega-3 lipid emulsion, “reversed cholestasis more frequently and more rapidly and was associated with fewer liver-related deaths with no deleterious side effects,” Dr. Sang Lee said at the annual meeting of the American Pediatric Surgical Association. Omegaven is marketed in Europe for parenteral feeding by Fresenius-Kabi; it is not approved by the Food and Drug Administration. The omega-6 emulsion for parenteral nutrition is marketed as Intralipid, also by Fresenius-Kabi, and is approved by the FDA. Dr. Lee and his associates at Children’s Hospital in Boston studied 18 infants with an average age of 3.4 months (range 1-7 months) who required parenteral nutrition because of short-bowel syndrome and had developed cholestasis. They were put on a parenteral formula that replaced the omega-6 emulsion with the omega-3 emulsion. The starting dose of omega-3 emulsion was 0.5 g/kg per day, administered for 2 days, after which the dose was boosted to 1 g/kg per day. The average omega-6 lipid dose was 2-3 g/kg per day. After 14 weeks, all of the patients treated with the omega-3 emulsion had reversal of their cholestasis, the study’s prima- A M E R I C A N C O L L E G E O F S U R G E O N S • D I V I S I O N O F E D U C AT I O N Education presents the Personal Financial Planning and Management Course for Residents and Young Surgeons, which uses an Objectives At the end of the course, the participants will be able to describe: ry end point, and also had normalization of their bilirubin level. In contrast, in a historical control group of 21 patients who received an omega-6 emulsion, cholestasis reversed in only 35% of patients after 14 weeks, said Dr. Lee, a surgeon at Children’s Hospital. The median time to reversal of cholestasis was 9 weeks with the omega3 emulsion, compared with a median of 44 weeks in the historical control group. The median time to cessation of parenteral nutrition was 14 weeks in the omega-3 fish oil group, compared with 23 weeks in the omega-6 soy emulsion group. In an analysis that controlled for baseline demographic and clinical differences, infants treated with the omega-3 emulsion were about 15 times as likely to have their cholestasis reversed as those treated with the omega-6 emulsion. Two of the 18 infants in the omega-3 group died; neither death was liver related. In contrast, 7 of the 21 patients in the historical control group died on parenteral nutrition, and 6 of those deaths were liver related. The only adverse event seen in the omega-3 group was an episode of essential fatty acid deficiency, but this was a biochemical finding without clinical consequences. The deficiency appeared to result from stopping parenteral nutrition early. Substitution of the omega-3 emulsion did not appear to produce any changes in coagulopathy, infection rates, or growth, Dr. Lee said. The Children’s Hospital group believes that omega-6 fatty acids have several adverse effects, including promoting steatosis, reducing biliary secretion, promoting inflammatory insults, causing mucosal atrophy, and promoting bacterial intensification. Substituting omega-3 fatty acids not only eliminates these adverse effects but also improves liver function and bile secretion, which leads to better gastrointestinal absorption of fat and other nutrients. Omega-3 fatty acids also are anti-inflammatory and cause less steatosis, said Dr. Lee. Based on the study findings, Dr. Lee and his associates have begun a prospective, blinded, randomized trial to compare the efficacy of omega-3 vs. omega-6 fatty acid emulsions in preventing cholestasis in infants receiving parenteral nutrition. Dr. Lee and his associates have not received commercial research support, nor do they have any other financial disclosures for their parenteral nutrition studies. ■ INDEX OF ADVERTISERS Ethicon Endo-Surgery, Inc. Echelon 45 General Scientific Corporation SurgiCam KCI V.A.C. Tissue Science Laboratories, Inc. Permacol Wyeth Pharmaceuticals Inc. TYGACIL 2 6 7 9 19-20 Intended audience: http://www.acs-resource.org
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