AustralieFrV1, Main, Exploration, bibRecord, 004F39

Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid) - A double-blind, randomised, multicentre study in adults

Identifieur interne : 004F39 ( Main/Exploration ); précédent : 004F38; suivant : 004F40

Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid) - A double-blind, randomised, multicentre study in adults

Auteurs : Stanislaw Klek [Pologne] ; Cecile Chambrier [France] ; Pierre Singer [Israël] ; Moshe Rubin [Israël] ; Tim Bowling [Royaume-Uni] ; Michael Staun [Danemark] ; Francisca Joly [France] ; Henrik Rasmussen [Danemark] ; Boyd J. Strauss [Australie] ; Geert Wanten [Pays-Bas] ; Ross Smith [Australie] ; Arun Abraham [Royaume-Uni] ; Kinga Szczepanek [Pologne] ; Jon Shaffer [Royaume-Uni]

Source :

Clinical nutrition : (Edinburgh) [ 0261-5614 ] ; 2013.

RBID : Pascal:13-0129128

Descripteurs français

Pascal (Inist)
- Voie parentérale, Lipide, Emulsion, Etude double insu, Randomisation, Adulte, Maladie métabolique, Nutrition parentérale.
Wicri :
- topic : Adulte.

English descriptors

KwdEn :
- Adult, Double blind study, Emulsion, Lipids, Metabolic diseases, Parenteral administration, Parenteral nutrition, Randomization.

Abstract

Precis: The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion containing four different types of oils is safe and well tolerated in long-term PN. Background & aim: Long-term safety and efficacy of a lipid emulsion containing soybean oil, medium-chain triglycerides (MCT), olive oil and fish oil and enriched in vitamin E have not yet been evaluated in adult patients requiring long-term parenteral nutrition (PN). Methods: Randomised, controlled, double-blind, multicentre study in 73 patients with stable intestinal failure, requiring PN with either soybean/MCT/olive/fish emulsion (SMOFlipid, n = 34) or soybean emulsion (Intralipid, control n ₌ 39) for 4 weeks. Safety and tolerance were monitored with standard clinical laboratory parameters, adverse events (AEs, according to the Common Terminology Criteria for Adverse Events (CTCAE) classification v 3.0) and vital signs. Fatty acid pattern in red blood cell phospholipids and plasma lipoproteins, serum Vitamin E, Interleukin (IL)-6, and soluble tumour necrosis (s-TNF)-receptor(R)II were also evaluated. Results: Mean concentrations of alanine transaminase (ALT), aspartate transaminase (AST) and total bilirubin, whilst remaining within the reference range, were significantly lower with soybean/MCT/olive/ fish (SMOF) oil emulsion after the treatment period compared to control. Eicosapentaenoic acid, docosahexaenoic acid and n-3/n-6 fatty acid ratio increased in the SMOF group, while they remained unchanged in the control in plasma and RBC. Serum α-tocopherol concentrations significantly increased in the study group compared to control (p = 0.0004). IL-6 and sTNF-RII levels did not change during the study period. Grade 4 (serious) adverse events occurred in 2 SMOF patients and in 8 control patients (p = 0.03). Conclusions: Soybean/MCT/olive/fish emulsion was safe and well tolerated over 4 weeks and leads to positive change in fatty acids profile.

Affiliations:

Australie, Danemark, France, Israël, Pays-Bas, Pologne, Royaume-Uni
Auvergne-Rhône-Alpes, Hovedstaden, Rhône-Alpes, Victoria (État)
Copenhague, Lyon, Melbourne

Links toward previous steps (curation, corpus...)

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Le document en format XML

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<author><name sortKey="Smith, Ross" sort="Smith, Ross" uniqKey="Smith R" first="Ross" last="Smith">Ross Smith</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid) - A double-blind, randomised, multicentre study in adults</title>
<author><name sortKey="Klek, Stanislaw" sort="Klek, Stanislaw" uniqKey="Klek S" first="Stanislaw" last="Klek">Stanislaw Klek</name>
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<s2>Krakow</s2>
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<author><name sortKey="Chambrier, Cecile" sort="Chambrier, Cecile" uniqKey="Chambrier C" first="Cecile" last="Chambrier">Cecile Chambrier</name>
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<author><name sortKey="Bowling, Tim" sort="Bowling, Tim" uniqKey="Bowling T" first="Tim" last="Bowling">Tim Bowling</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>University Hospital</s1>
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<wicri:noRegion>University Hospital</wicri:noRegion>
</affiliation>
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<author><name sortKey="Staun, Michael" sort="Staun, Michael" uniqKey="Staun M" first="Michael" last="Staun">Michael Staun</name>
<affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Rigshospitalet</s1>
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<s3>DNK</s3>
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<region type="région" nuts="2">Hovedstaden</region>
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</affiliation>
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<author><name sortKey="Joly, Francisca" sort="Joly, Francisca" uniqKey="Joly F" first="Francisca" last="Joly">Francisca Joly</name>
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<s3>FRA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Clichy la Garenne</wicri:noRegion>
<wicri:noRegion>Hopital Beaujon, Clichy la Garenne</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rasmussen, Henrik" sort="Rasmussen, Henrik" uniqKey="Rasmussen H" first="Henrik" last="Rasmussen">Henrik Rasmussen</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Aalborg University Hospital</s1>
<s2>Aalborg</s2>
<s3>DNK</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Danemark</country>
<wicri:noRegion>Aalborg University Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Strauss, Boyd J" sort="Strauss, Boyd J" uniqKey="Strauss B" first="Boyd J." last="Strauss">Boyd J. Strauss</name>
<affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Monash Medical Centre, Monash University</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wanten, Geert" sort="Wanten, Geert" uniqKey="Wanten G" first="Geert" last="Wanten">Geert Wanten</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>University Medical Center Nijmegen</s1>
<s3>NLD</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<wicri:noRegion>University Medical Center Nijmegen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Smith, Ross" sort="Smith, Ross" uniqKey="Smith R" first="Ross" last="Smith">Ross Smith</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>North Shore Private Hospital</s1>
<s2>Saint Leonards</s2>
<s3>AUS</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>North Shore Private Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Abraham, Arun" sort="Abraham, Arun" uniqKey="Abraham A" first="Arun" last="Abraham">Arun Abraham</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Salford Royal NHS Foundation Trust, Intestinal Failure Unit</s1>
<s2>Salford M68HD</s2>
<s3>GBR</s3>
<sZ>12 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Salford M68HD</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Szczepanek, Kinga" sort="Szczepanek, Kinga" uniqKey="Szczepanek K" first="Kinga" last="Szczepanek">Kinga Szczepanek</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Jagiellonian University Medical College</s1>
<s2>Krakow</s2>
<s3>POL</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Pologne</country>
<wicri:noRegion>Jagiellonian University Medical College</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Shaffer, Jon" sort="Shaffer, Jon" uniqKey="Shaffer J" first="Jon" last="Shaffer">Jon Shaffer</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Salford Royal NHS Foundation Trust, Intestinal Failure Unit</s1>
<s2>Salford M68HD</s2>
<s3>GBR</s3>
<sZ>12 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Salford M68HD</wicri:noRegion>
</affiliation>
</author>
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<series><title level="j" type="main">Clinical nutrition : (Edinburgh)</title>
<title level="j" type="abbreviated">Clin. nutr. : (Edinb.)</title>
<idno type="ISSN">0261-5614</idno>
<imprint><date when="2013">2013</date>
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<title level="j" type="abbreviated">Clin. nutr. : (Edinb.)</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Double blind study</term>
<term>Emulsion</term>
<term>Lipids</term>
<term>Metabolic diseases</term>
<term>Parenteral administration</term>
<term>Parenteral nutrition</term>
<term>Randomization</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Voie parentérale</term>
<term>Lipide</term>
<term>Emulsion</term>
<term>Etude double insu</term>
<term>Randomisation</term>
<term>Adulte</term>
<term>Maladie métabolique</term>
<term>Nutrition parentérale</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Adulte</term>
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<front><div type="abstract" xml:lang="en">Precis: The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion containing four different types of oils is safe and well tolerated in long-term PN. Background & aim: Long-term safety and efficacy of a lipid emulsion containing soybean oil, medium-chain triglycerides (MCT), olive oil and fish oil and enriched in vitamin E have not yet been evaluated in adult patients requiring long-term parenteral nutrition (PN). Methods: Randomised, controlled, double-blind, multicentre study in 73 patients with stable intestinal failure, requiring PN with either soybean/MCT/olive/fish emulsion (SMOFlipid, n = 34) or soybean emulsion (Intralipid, control n <sub>=</sub>
 39) for 4 weeks. Safety and tolerance were monitored with standard clinical laboratory parameters, adverse events (AEs, according to the Common Terminology Criteria for Adverse Events (CTCAE) classification v 3.0) and vital signs. Fatty acid pattern in red blood cell phospholipids and plasma lipoproteins, serum Vitamin E, Interleukin (IL)-6, and soluble tumour necrosis (s-TNF)-receptor(R)II were also evaluated. Results: Mean concentrations of alanine transaminase (ALT), aspartate transaminase (AST) and total bilirubin, whilst remaining within the reference range, were significantly lower with soybean/MCT/olive/ fish (SMOF) oil emulsion after the treatment period compared to control. Eicosapentaenoic acid, docosahexaenoic acid and n-3/n-6 fatty acid ratio increased in the SMOF group, while they remained unchanged in the control in plasma and RBC. Serum α-tocopherol concentrations significantly increased in the study group compared to control (p = 0.0004). IL-6 and sTNF-RII levels did not change during the study period. Grade 4 (serious) adverse events occurred in 2 SMOF patients and in 8 control patients (p = 0.03). Conclusions: Soybean/MCT/olive/fish emulsion was safe and well tolerated over 4 weeks and leads to positive change in fatty acids profile.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Danemark</li>
<li>France</li>
<li>Israël</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
</country>
<region><li>Auvergne-Rhône-Alpes</li>
<li>Hovedstaden</li>
<li>Rhône-Alpes</li>
<li>Victoria (État)</li>
</region>
<settlement><li>Copenhague</li>
<li>Lyon</li>
<li>Melbourne</li>
</settlement>
</list>
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   |texte=   Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid) - A double-blind, randomised, multicentre study in adults
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	Serveur d'exploration sur les relations entre la France et l'Australie
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Serveur d'exploration sur les relations entre la France et l'Australie

Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid) - A double-blind, randomised, multicentre study in adults

Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid) - A double-blind, randomised, multicentre study in adults

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