[Usefulness of fenspiride in the treatment of acute otitis media in children].
Acute otitis media is very general disease and concerns every child practically. The shortening the time of treatment as well as quick decrease of symptoms, and mainly the pain have large meaning in treatment of this disease. Combined treatment of fenspiride and typical treatment of otitis media permits as our investigations show on quicker and observed at children's larger number decrease of symptoms in children with acute otitis media. The aim of the study was to observe effectiveness of combined treatment with antibiotic and fenspiride in children with acute otitis media.


METHODS
The study comprised 40 children (mean age 8.2 years). The diagnosis of acute otitis media based on medical history data, otolaryngological examination and audiometry (tone and impedance). Children with GERD, hypersensitivity to amoxicillin and fenspiride as well as hypertrophy of adenoid were excluded from the study. Children were divided in two equal groups randomly. All children received amoxicillin in dose 80 mg/kg/day in three partite doses (Amotaks, Polfa Tarchomin Poland) as well as oxymethazolin 0.05% nasal drops 3 x day 1-2 drops (0.05% Nasivin, Merck Germany). In children from second group fenspiride was applied in dose 2 ml/kg/day in three divided doses (Eurespal, Servier Francja) additionally. Treatment was provided by 10 days. During the treatment parents made record of recession in 10 point scale, estimating following parameters: the pain of ear, bother, raised the temperature of body, loss of appetite, vomiting, diarrhea, otorrhea and crying. After end of treatment control otolaryngological and audiological examinations were performed.


RESULTS
In studied children symptoms were similar, and the pain of ear was in both groups main suffering. Vomiting and diarrhea the most seldom were observed. In children with acute otitis media treated additionally with fenspiride statistically significant (p<0.01) quicker recession of clinical symptoms was observed. Statistically significant (p<0.01) reduction was observed of such symptoms as the pain of ear, bother, raised of body temperature as well as crying in children treated additionally with fenspiride in comparison to children treated only with antibiotic. Earlier return of hearing and state of middle ear was observed in children from group II than in children from group I (p<0.01). We observed also statistically significant (p<0.01) improvement of hearing estimated in tonal audiometry and impedance in this group. The undesirable symptoms during the treatment were not mentioned.


CONCLUSIONS
Our study show that combined treatment with fenspiride and antibiotic in the treatment of acute otitis media in children causes quicker reduction of symptoms as well as improvement in audiological parameters (tone and impedance).
Zielnik-Jurkiewicz
Beata
B
Oddział Otolaryngologiczny SZPZOZ w Warszawie. bzielnik@lekarz.net
Jurkiewicz
Dariusz
D
D000208:Acute Disease; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D002648:Child; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D010109:Oxymetazoline / Q000008:administration & dosage*; D013141:Spiro Compounds / Q000008:administration & dosage*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D013141:Spiro Compounds; D000658:Amoxicillin; D010109:Oxymetazoline; C084775:fenspiride