Source:http://linkedlifedata.com/resource/pubmed/id/11597376
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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
16
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| pubmed:dateCreated |
2001-10-12
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| pubmed:abstractText |
We have conducted a prospective controlled randomised clinical study testing for the efficacy of topical GM-CSF (molgramostim), as compared to the combined topical use of an antiseptic agent (povidone-iodine) and amphotericin B (AA) in patients with chemotherapy-induced mucositis World Health Organization (WHO) grades I-III. 31 patients (17 females, 14 males) developing oral mucositis following the administration of 5-fluorouracil (5-FU)-based chemotherapy were entered into the present trial. 15 patients were randomised to receive GM-CSF mouthwashes, whereas 16 patients were randomised into the control arm to receive AA. Reported history (P=0.6109) and grading of oral mucositis (2.1+/-0.7, respectively; P=0.9867) were balanced and equally distributed between the two groups. The mean size of lesions of oral mucositis was 1.5+/-0.6 cm (range: 0.7-2.5 cm) in the GM-CSF group and 1.2+/-0.5 cm (range: 0.5-2.5 cm) in the AA group (P=0.08), respectively. The mean number of oral mucositis lesions was 1.9+/-1.1 (range: 1-4) in the GM-CSF group and 2.1+/-1.2 (range: 1-4) in the AA group (P=0.63), respectively. None of the patients had previously received colony stimulating factors either topically or systemically. Treatment for oral mucositis was initiated on day 2.7+/-1.2 (range: day 1-8) after onset of symptoms in the GM-CSF group and on day 1.8+/-1.4 (range: day 1-3; P=0.11) in the AA group. The topical application of GM-CSF resulted in a significantly shorter duration and quicker resolution of oral mucositis, as compared to AA including both, pretreatment plus treatment periods (5.3+/-2.5 versus 8.1+/-1.5 days; P=0.0008) as well as the necessary duration of treatment needed until complete remission of lesions (2.8+/-0.7 versus 6.3+/-1.1 days; P<0.0001). A systemic effect of topical GM-CSF upon the number of peripheral blood leukocytes or granulocytes was excluded. We conclude that the topical application of GM-CSF by mouthwash significantly abbreviated the duration and relieved patients from symptoms of chemotherapy-induced mucositis and was superior to the topical application of AA.
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| pubmed:commentsCorrections | |
| pubmed:language |
eng
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| pubmed:journal | |
| pubmed:citationSubset |
IM
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| pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Amphotericin B,
http://linkedlifedata.com/resource/pubmed/chemical/Antimetabolites, Antineoplastic,
http://linkedlifedata.com/resource/pubmed/chemical/Fluorouracil,
http://linkedlifedata.com/resource/pubmed/chemical/Granulocyte-Macrophage...,
http://linkedlifedata.com/resource/pubmed/chemical/Mouthwashes,
http://linkedlifedata.com/resource/pubmed/chemical/Povidone-Iodine,
http://linkedlifedata.com/resource/pubmed/chemical/Protective Agents,
http://linkedlifedata.com/resource/pubmed/chemical/Recombinant Proteins,
http://linkedlifedata.com/resource/pubmed/chemical/molgramostim
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| pubmed:status |
MEDLINE
|
| pubmed:month |
Nov
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| pubmed:issn |
0959-8049
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| pubmed:author | |
| pubmed:issnType |
Print
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| pubmed:volume |
37
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| pubmed:owner |
NLM
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| pubmed:authorsComplete |
Y
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| pubmed:pagination |
1994-2002
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| pubmed:dateRevised |
2004-11-17
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| pubmed:meshHeading |
pubmed-meshheading:11597376-Adult,
pubmed-meshheading:11597376-Aged,
pubmed-meshheading:11597376-Aged, 80 and over,
pubmed-meshheading:11597376-Amphotericin B,
pubmed-meshheading:11597376-Antimetabolites, Antineoplastic,
pubmed-meshheading:11597376-Drug Administration Schedule,
pubmed-meshheading:11597376-Female,
pubmed-meshheading:11597376-Fluorouracil,
pubmed-meshheading:11597376-Granulocyte-Macrophage Colony-Stimulating Factor,
pubmed-meshheading:11597376-Humans,
pubmed-meshheading:11597376-Leukocyte Count,
pubmed-meshheading:11597376-Male,
pubmed-meshheading:11597376-Middle Aged,
pubmed-meshheading:11597376-Mouth Mucosa,
pubmed-meshheading:11597376-Mouthwashes,
pubmed-meshheading:11597376-Povidone-Iodine,
pubmed-meshheading:11597376-Prospective Studies,
pubmed-meshheading:11597376-Protective Agents,
pubmed-meshheading:11597376-Recombinant Proteins,
pubmed-meshheading:11597376-Severity of Illness Index,
pubmed-meshheading:11597376-Single-Blind Method,
pubmed-meshheading:11597376-Stomatitis,
pubmed-meshheading:11597376-Time Factors,
pubmed-meshheading:11597376-Treatment Outcome
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| pubmed:year |
2001
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| pubmed:articleTitle |
Decrease of duration and symptoms in chemotherapy-induced oral mucositis by topical GM-CSF: results of a prospective randomised trial.
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| pubmed:affiliation |
Department of Medicine I, Division of Oncology, University Hospital, 18-20 Waehringer Guertel, A-1090, Vienna, Austria.
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| pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial
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