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KMID : 0378020070500030047
New Medical Journal
2007 Volume.50 No. 3 p.47 ~ p.52
The Comparison of Efficacy and Safety between Talniflumate (Somalgen¢ç) and Ibuprofen (Carol-F¢ç) in Patients of Chronic Otitis Media with Otorrhea
Park Se-Jin

Kim Yang-Soo
Jung Hak-Hyun
Im Gi-Jung
Kim Woo-Joo
Hwang Ho-Yeon
Abstract
Background and Objectives : Chronic otitis media is a chronic infectious disease in middle ear and mastoid cavity accompanied with dehiscence of tympanic membrane, and mostly accompanies otorrhea. Treatment of otorrhea in chronic otitis media is a significant process to achieve the treatment objectives, which is elimination of inflammation and prevention of its recurrence, improvement in audition, and prevention of complication. The most important medication in treatment is antibiotics by sensitivity to strain, however subsidiary administration of NSAID for anti-inflammatory and analgesic effect is commonly practiced. Thus the objective of this study is to assess the analgesic and anti-inflammatory
effect, and relative efficacy of Talniflumate (Somalgen¢ç) and Ibuprofen (Carol-F¢ç), which are typical NSAIDs, by comparing their anti-inflammatory and analgesic effect, therapeutic effect in otitis, and side effects.

Material and Methods : Adult outpatients over 18 years old with chronic otitis media who visited Korea University Anam Hospital Department of Otorhinolaryngology, and who has had perforation in tympanic membrane for more than at least 3 months and history of otorrhea for at least 3 months before, were randomized and administered 1 tablet of Somalgen or Carol-F twice a day. Elimination of otorrhea was observed by autoscope and was classified into phases from 0 (without otorrhea) to 3 (with otorrhea flowed out from auris). Analgesic effect was recorded by VAS(visual analogue scale) at each visit from the initiation of treatment. Anti-inflammatory effect was assessed by WBC, neutrophile percent
and ESR at the baseline and endpoint. Besides, test on CBC, differential count AST/ALT, BUN/Cr. was conducted at the baseline and endpoint in order to assess side effects, and existence of nausea, vomiting and brash was also recorded.

Results: There was no difference in duration of treatment for otorrhea and analgesic effect between the two arms. There was no significant difference in stabilization of WBC and neutrophil level between the two arms. However, ESR level decreased more rapidly in the arm administered with Somalgen than in the arm administered with Carol-F. There were no side effects in all two arms.

Conclusion: Talniflumate is a medicine for chronic otitis media with excellent antiinflammatory and analgesic effect, and is considered to be useful in reducing treatment period and especially in normalization of inflammatory level. In this study, there was no brash which is a common side effect of antibiotics and NSAID.
KEYWORD
Talniflumate, Ibuprofen, Otorrhea, Efficacy
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