Clinical Efficacy of Tosufloxacin Tosilate Hydrate for the Treatment of Acute Otitis Media in Children

Abstract

Special attention has been focused on the recent problem of pediatric acute otitis media. The increase in the number of pediatric patients with intractable acute otitis media has been a serious problem in the clinical setting of ENT clinics and hospitals. Such a change in the clinical figures of otitis media may be due to the social environment, including the tendency for more very young children to be looked after at nurseries, and the increase in drug-resistant bacteria. In the clinical guidelines for the treatment of pediatric acute otitis media, published in 2006 and revised in 2009, a classification of severity according to scoring of symptoms and tympanic membrane findings was proposed and a severity-oriented treatment algorithm was recommended. In response to the proliferation of drug-resistant bacteria, we have also emphasized the importance of the proper use of antimicrobials and have promoted a correct assessment of the clinical efficacy of various antimicrobial agents according to the scoring system recommended by the guidelines. In this study, we employed this severity classification by the scoring system to examine the usefulness and bacteriological efficacy of tosufloxacin (TFLX) fine granules (6 mg/kg bid), a novel pediatric quinolone antimicrobial, in 106 children aged 15 or under diagnosed with moderate or severe acute pediatric otitis media. We obtained the following results. The clinical response rate to TFLX was 98.1% (104/106) according to the score-oriented evaluation and 97.2% (103/106) as conventionally judged by the treating physicians. Bacterial pathogens detected in this study were Haemophilus influenzae 37.7% (40/106), Streptococcus pneumoniae 32.1% (34/106) and Moraxella catarrhalis 6.6% (7/106). At the time of completion of TFLX administration, the rate of bacterial elimination was 95.8% (69/72). Only one patient experienced mild diarrhea as an adverse drug reaction.