Safety and Efficacy of a Fish-Oil-Based Fat Emulsion in the Treatment of Parenteral Nutrition-Associated Liver Disease
Parenteral nutrition-associated liver disease can be a progressive and fatal entity in children with short-bowel syndrome. Soybean-fat emulsions provided as part of standard parenteral nutrition may contribute to its pathophysiology. We compared safety and efficacy outcomes of a fish-oil-based fat e...
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Veröffentlicht in: | Pediatrics (Evanston) 2008-03, Vol.121 (3), p.e678-e686 |
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creator | Gura, Kathleen M Lee, Sang Valim, Clarissa Zhou, Jing Kim, Sendia Modi, Biren P Arsenault, Danielle A Strijbosch, Robbert A. M Lopes, Suzanne Duggan, Christopher Puder, Mark |
description | Parenteral nutrition-associated liver disease can be a progressive and fatal entity in children with short-bowel syndrome. Soybean-fat emulsions provided as part of standard parenteral nutrition may contribute to its pathophysiology.
We compared safety and efficacy outcomes of a fish-oil-based fat emulsion in 18 infants with short-bowel syndrome who developed cholestasis (serum direct bilirubin level of > 2 mg/dL) while receiving soybean emulsions with those from a historical cohort of 21 infants with short-bowel syndrome who also developed cholestasis while receiving soybean emulsions. The primary end point was time to reversal of cholestasis (3 consecutive measurements of serum direct bilirubin level of < or = 2 mg/dL).
Among survivors, the median time to reversal of cholestasis was 9.4 and 44.1 weeks in the fish-oil and historical cohorts, respectively. Subjects who received fish-oil-based emulsion experienced reversal of cholestasis 4.8 times faster than those who received soybean emulsions and 6.8 times faster in analysis adjusted for baseline bilirubin concentration, gestational age, and the diagnosis of necrotizing enterocolitis. A total of 2 deaths and 0 liver transplantations were recorded in the fish-oil cohort and 7 deaths and 2 transplantations in the historical cohort. The provision of fish-oil-based fat emulsion was not associated with essential fatty acid deficiency, hypertriglyceridemia, coagulopathy, infections, or growth delay.
Parenteral fish-oil-based fat emulsions are safe and may be effective in the treatment of parenteral nutrition-associated liver disease. |
doi_str_mv | 10.1542/peds.2007-2248 |
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We compared safety and efficacy outcomes of a fish-oil-based fat emulsion in 18 infants with short-bowel syndrome who developed cholestasis (serum direct bilirubin level of > 2 mg/dL) while receiving soybean emulsions with those from a historical cohort of 21 infants with short-bowel syndrome who also developed cholestasis while receiving soybean emulsions. The primary end point was time to reversal of cholestasis (3 consecutive measurements of serum direct bilirubin level of < or = 2 mg/dL).
Among survivors, the median time to reversal of cholestasis was 9.4 and 44.1 weeks in the fish-oil and historical cohorts, respectively. Subjects who received fish-oil-based emulsion experienced reversal of cholestasis 4.8 times faster than those who received soybean emulsions and 6.8 times faster in analysis adjusted for baseline bilirubin concentration, gestational age, and the diagnosis of necrotizing enterocolitis. A total of 2 deaths and 0 liver transplantations were recorded in the fish-oil cohort and 7 deaths and 2 transplantations in the historical cohort. The provision of fish-oil-based fat emulsion was not associated with essential fatty acid deficiency, hypertriglyceridemia, coagulopathy, infections, or growth delay.
Parenteral fish-oil-based fat emulsions are safe and may be effective in the treatment of parenteral nutrition-associated liver disease.</description><identifier>ISSN: 0031-4005</identifier><identifier>EISSN: 1098-4275</identifier><identifier>DOI: 10.1542/peds.2007-2248</identifier><identifier>PMID: 18310188</identifier><identifier>CODEN: PEDIAU</identifier><language>eng</language><publisher>United States: Am Acad Pediatrics</publisher><subject>Babies ; Case-Control Studies ; Cholestasis - etiology ; Cholestasis - mortality ; Cholestasis - therapy ; Cohort Studies ; Comparative analysis ; Fat Emulsions, Intravenous - therapeutic use ; Female ; Fish oils ; Follow-Up Studies ; Gallbladder diseases ; Hospitals, Pediatric ; Humans ; Infant ; Infant, Newborn ; Kaplan-Meier Estimate ; Liver diseases ; Liver Failure - prevention & control ; Liver Function Tests ; Male ; Medical treatment ; Parenteral nutrition ; Parenteral Nutrition, Total - adverse effects ; Parenteral Nutrition, Total - methods ; Pediatrics ; Probability ; Reference Values ; Retrospective Studies ; Risk Assessment ; Severity of Illness Index ; Short Bowel Syndrome - diagnosis ; Short Bowel Syndrome - mortality ; Short Bowel Syndrome - therapy ; Soybean Oil - therapeutic use ; Statistics, Nonparametric ; Survival Analysis ; Treatment Outcome</subject><ispartof>Pediatrics (Evanston), 2008-03, Vol.121 (3), p.e678-e686</ispartof><rights>Copyright American Academy of Pediatrics Mar 2008</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c457t-4b3fa2125fe715c6e8c4657f1ea2a1aa385e9674b792c5ba994e1318e99559583</citedby><cites>FETCH-LOGICAL-c457t-4b3fa2125fe715c6e8c4657f1ea2a1aa385e9674b792c5ba994e1318e99559583</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18310188$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gura, Kathleen M</creatorcontrib><creatorcontrib>Lee, Sang</creatorcontrib><creatorcontrib>Valim, Clarissa</creatorcontrib><creatorcontrib>Zhou, Jing</creatorcontrib><creatorcontrib>Kim, Sendia</creatorcontrib><creatorcontrib>Modi, Biren P</creatorcontrib><creatorcontrib>Arsenault, Danielle A</creatorcontrib><creatorcontrib>Strijbosch, Robbert A. M</creatorcontrib><creatorcontrib>Lopes, Suzanne</creatorcontrib><creatorcontrib>Duggan, Christopher</creatorcontrib><creatorcontrib>Puder, Mark</creatorcontrib><title>Safety and Efficacy of a Fish-Oil-Based Fat Emulsion in the Treatment of Parenteral Nutrition-Associated Liver Disease</title><title>Pediatrics (Evanston)</title><addtitle>Pediatrics</addtitle><description>Parenteral nutrition-associated liver disease can be a progressive and fatal entity in children with short-bowel syndrome. Soybean-fat emulsions provided as part of standard parenteral nutrition may contribute to its pathophysiology.
We compared safety and efficacy outcomes of a fish-oil-based fat emulsion in 18 infants with short-bowel syndrome who developed cholestasis (serum direct bilirubin level of > 2 mg/dL) while receiving soybean emulsions with those from a historical cohort of 21 infants with short-bowel syndrome who also developed cholestasis while receiving soybean emulsions. The primary end point was time to reversal of cholestasis (3 consecutive measurements of serum direct bilirubin level of < or = 2 mg/dL).
Among survivors, the median time to reversal of cholestasis was 9.4 and 44.1 weeks in the fish-oil and historical cohorts, respectively. Subjects who received fish-oil-based emulsion experienced reversal of cholestasis 4.8 times faster than those who received soybean emulsions and 6.8 times faster in analysis adjusted for baseline bilirubin concentration, gestational age, and the diagnosis of necrotizing enterocolitis. A total of 2 deaths and 0 liver transplantations were recorded in the fish-oil cohort and 7 deaths and 2 transplantations in the historical cohort. The provision of fish-oil-based fat emulsion was not associated with essential fatty acid deficiency, hypertriglyceridemia, coagulopathy, infections, or growth delay.
Parenteral fish-oil-based fat emulsions are safe and may be effective in the treatment of parenteral nutrition-associated liver disease.</description><subject>Babies</subject><subject>Case-Control Studies</subject><subject>Cholestasis - etiology</subject><subject>Cholestasis - mortality</subject><subject>Cholestasis - therapy</subject><subject>Cohort Studies</subject><subject>Comparative analysis</subject><subject>Fat Emulsions, Intravenous - therapeutic use</subject><subject>Female</subject><subject>Fish oils</subject><subject>Follow-Up Studies</subject><subject>Gallbladder diseases</subject><subject>Hospitals, Pediatric</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Kaplan-Meier Estimate</subject><subject>Liver diseases</subject><subject>Liver Failure - prevention & control</subject><subject>Liver Function Tests</subject><subject>Male</subject><subject>Medical treatment</subject><subject>Parenteral nutrition</subject><subject>Parenteral Nutrition, Total - adverse effects</subject><subject>Parenteral Nutrition, Total - methods</subject><subject>Pediatrics</subject><subject>Probability</subject><subject>Reference Values</subject><subject>Retrospective Studies</subject><subject>Risk Assessment</subject><subject>Severity of Illness Index</subject><subject>Short Bowel Syndrome - diagnosis</subject><subject>Short Bowel Syndrome - mortality</subject><subject>Short Bowel Syndrome - therapy</subject><subject>Soybean Oil - therapeutic use</subject><subject>Statistics, Nonparametric</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><issn>0031-4005</issn><issn>1098-4275</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU1vEzEQhi0EomnhyhFZHLht6s-191hKUpAiikQ5WxNnlrjaj2B7i_Lv8SqRQFw4zRyeeTUzDyFvOFtyrcT1AXdpKRgzlRDKPiMLzhpbKWH0c7JgTPJKMaYvyGVKj4wxpY14SS64lZxxaxfk6Ru0mI8Uhh1dtW3w4I90bCnQdUj76j501QdIuKNryHTVT10K40DDQPMe6UNEyD0OeZ74CrF0GKGjX6YcQy5gdZPS6APkErAJTxjpx5Cw5L0iL1roEr4-1yvyfb16uP1Ube7vPt_ebCpfNs2V2soWBBe6RcO1r9F6VWvTcgQBHEBajU1t1NY0wustNI1CLrnFptG60VZekfen3EMcf06YsutD8th1MOA4JWeYrJlh5r-gYHWtuGUFfPcP-DhOcShHOCFsWUgqUaDlCfJxTCli6w4x9BCPjjM3e3OzNzd7c7O3MvD2nDpte9z9wc-iCnB9Avbhx_5XiDgnlMfG4NNfLRfcSYe1sfI344yjjw</recordid><startdate>20080301</startdate><enddate>20080301</enddate><creator>Gura, Kathleen M</creator><creator>Lee, Sang</creator><creator>Valim, Clarissa</creator><creator>Zhou, Jing</creator><creator>Kim, Sendia</creator><creator>Modi, Biren P</creator><creator>Arsenault, Danielle A</creator><creator>Strijbosch, Robbert A. 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M</au><au>Lopes, Suzanne</au><au>Duggan, Christopher</au><au>Puder, Mark</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and Efficacy of a Fish-Oil-Based Fat Emulsion in the Treatment of Parenteral Nutrition-Associated Liver Disease</atitle><jtitle>Pediatrics (Evanston)</jtitle><addtitle>Pediatrics</addtitle><date>2008-03-01</date><risdate>2008</risdate><volume>121</volume><issue>3</issue><spage>e678</spage><epage>e686</epage><pages>e678-e686</pages><issn>0031-4005</issn><eissn>1098-4275</eissn><coden>PEDIAU</coden><abstract>Parenteral nutrition-associated liver disease can be a progressive and fatal entity in children with short-bowel syndrome. Soybean-fat emulsions provided as part of standard parenteral nutrition may contribute to its pathophysiology.
We compared safety and efficacy outcomes of a fish-oil-based fat emulsion in 18 infants with short-bowel syndrome who developed cholestasis (serum direct bilirubin level of > 2 mg/dL) while receiving soybean emulsions with those from a historical cohort of 21 infants with short-bowel syndrome who also developed cholestasis while receiving soybean emulsions. The primary end point was time to reversal of cholestasis (3 consecutive measurements of serum direct bilirubin level of < or = 2 mg/dL).
Among survivors, the median time to reversal of cholestasis was 9.4 and 44.1 weeks in the fish-oil and historical cohorts, respectively. Subjects who received fish-oil-based emulsion experienced reversal of cholestasis 4.8 times faster than those who received soybean emulsions and 6.8 times faster in analysis adjusted for baseline bilirubin concentration, gestational age, and the diagnosis of necrotizing enterocolitis. A total of 2 deaths and 0 liver transplantations were recorded in the fish-oil cohort and 7 deaths and 2 transplantations in the historical cohort. The provision of fish-oil-based fat emulsion was not associated with essential fatty acid deficiency, hypertriglyceridemia, coagulopathy, infections, or growth delay.
Parenteral fish-oil-based fat emulsions are safe and may be effective in the treatment of parenteral nutrition-associated liver disease.</abstract><cop>United States</cop><pub>Am Acad Pediatrics</pub><pmid>18310188</pmid><doi>10.1542/peds.2007-2248</doi></addata></record> |
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subjects | Babies Case-Control Studies Cholestasis - etiology Cholestasis - mortality Cholestasis - therapy Cohort Studies Comparative analysis Fat Emulsions, Intravenous - therapeutic use Female Fish oils Follow-Up Studies Gallbladder diseases Hospitals, Pediatric Humans Infant Infant, Newborn Kaplan-Meier Estimate Liver diseases Liver Failure - prevention & control Liver Function Tests Male Medical treatment Parenteral nutrition Parenteral Nutrition, Total - adverse effects Parenteral Nutrition, Total - methods Pediatrics Probability Reference Values Retrospective Studies Risk Assessment Severity of Illness Index Short Bowel Syndrome - diagnosis Short Bowel Syndrome - mortality Short Bowel Syndrome - therapy Soybean Oil - therapeutic use Statistics, Nonparametric Survival Analysis Treatment Outcome |
title | Safety and Efficacy of a Fish-Oil-Based Fat Emulsion in the Treatment of Parenteral Nutrition-Associated Liver Disease |
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