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Irsogladine maleate reduces the incidence of fluorouracil-based chemotherapy-induced oral mucositis.
MedLine Citation:
PMID:  23152361     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BackgroundOral mucositis is one of the most common side-effects of 5-fluorouracil (5-FU)-based chemotherapy. The objective of this study was to evaluate the effects of irsogladine maleate (IM) on fluorouracil-induced oral mucositis through a double-blind, placebo controlled trial.Patients and methodsPatients (N = 66) were randomly assigned to receive either placebo or IM (4 mg/day for 14 consecutive days). The incidence and maximum severity of fluorouracil-induced oral mucositis and safety of the irsogladine dosing regimen were evaluated.ResultsA cohort of 33 patients received placebo and 33 patients received IM. The incidence of oral mucositis was significantly lower for IM than for placebo (27% versus 73%; P < 0.001 by chi-square test). Specific adverse events considered related to IM were not found.ConclusionIM significantly reduced the incidence and maximum severity of oral mucositis in patients treated with 5-FU-chemotherapy.
Authors:
M Nomura; M Kamata; H Kojima; K Hayashi; S Sawada
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-11-14
Journal Detail:
Title:  Annals of oncology : official journal of the European Society for Medical Oncology / ESMO     Volume:  -     ISSN:  1569-8041     ISO Abbreviation:  Ann. Oncol.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9007735     Medline TA:  Ann Oncol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Radiology, Kansai Medical University, Hirakata, Japan.
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