Source:http://linkedlifedata.com/resource/pubmed/id/17261503
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
1
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pubmed:dateCreated |
2007-1-30
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pubmed:abstractText |
To investigate the efficacy of using recombinant human interleukin 11 (rhIL-11) to reduce the need for platelet transfusions, we performed a randomized, double-blind phase II/III study with 110 acute myelogenous leukemia (AML) patients in the first complete remission. Following chemotherapy patients were subcutaneously administered either placebo (n=37) or rhIL-11 at a dose of 25 microg/kg (n=37) or 50 microg/kg (n=36). rhIL-11 administration was well tolerated. There was no difference between the rhIL-11 and placebo groups in the frequency and volume of platelet transfusions. In a perprotocol analysis set (101 patients), the platelet transfusion frequency in the 50-microg/kg group (3.0 +/- 1.76 times) was significantly lower than in the placebo group (3.9 +/-2.35 times; multiplicity-adjusted P= .049). We analyzed infection-related events retrospectively. The frequency of fever was significantly decreased in the 50-microg/kg, 25-microg/kg, and placebo groups (66.7%, 70.3%, and 89.2%, respectively; P= .018, Cochran-Armitage test). Stomatitis was less frequent in the 50-microg/kg and 25-microg/kg groups (2.8% and 0%, respectively) than in the placebo group (21.6%, P= .0012). These results show that rhIL-11 does not reduce the platelet transfusion requirement in AML patients, but the retrospective analysis confirms the previous finding that rhIL-11 reduces infection in patients undergoing chemotherapy.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Jan
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pubmed:issn |
0925-5710
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
85
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
59-69
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pubmed:dateRevised |
2007-11-15
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pubmed:meshHeading |
pubmed-meshheading:17261503-Adolescent,
pubmed-meshheading:17261503-Adult,
pubmed-meshheading:17261503-Double-Blind Method,
pubmed-meshheading:17261503-Female,
pubmed-meshheading:17261503-Humans,
pubmed-meshheading:17261503-Infection,
pubmed-meshheading:17261503-Interleukin-11,
pubmed-meshheading:17261503-Leukemia, Myeloid, Acute,
pubmed-meshheading:17261503-Male,
pubmed-meshheading:17261503-Middle Aged,
pubmed-meshheading:17261503-Placebos,
pubmed-meshheading:17261503-Platelet Transfusion,
pubmed-meshheading:17261503-Recombinant Proteins,
pubmed-meshheading:17261503-Retrospective Studies,
pubmed-meshheading:17261503-Stomatitis
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pubmed:year |
2007
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pubmed:articleTitle |
A multicenter randomized, double-blind, placebo-controlled late-phase II/III study of recombinant human interleukin 11 in acute myelogenous leukemia.
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pubmed:affiliation |
Division of Hematology, NTT Kanto Medical Center, Tokyo, Japan. usuki@kmc.mhc.east.ntt.co.jp
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pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Multicenter Study,
Clinical Trial, Phase II,
Clinical Trial, Phase III
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