[Efficacy of cefditoren pivoxil in the treatment of acute otitis media due to benzylpenicillin-insensitive Streptococcus pneumoniae].

Clinical and bacteriological studies were carried out on cefditoren pivoxil (CDTR-PI) granule in infantile purulent acute otitis media treated at general practice settings and the following findings were obtained: 1. Two hundred forty eight strains were isolated from 210 patients, almost all of which (81.1%) harbored the following two strains: Streptococcus pneumoniae (42.3%) and Haemophilus influenzae (38.8%). Among S. pneumoniae, benzylpenicillin (PCG)-insensitive S. pneumoniae, (PISP) or PCG-resistant S. pneumoniae (PRSP) was 36.2%, corresponding to 15.3% of all the isolates and found in 18% of all patients. 2. The bacteria in the middle ear discharge and the nasopharyngeal swabs were correlated with conformity rate of more than 80% with regard to Streptococcus pyogenes, S. pneumoniae and H. influenzae but no Staphylococcus aureus was detected simultaneously from the two sources in any of the patients. S. aureus and coagulase-negative staphylococci (CNS) were considered to be contaminants that were originated from the external auditory meatus at the time of sampling. 3. Frequencies of isolation of S. pneumoniae from different age groups were higher in a lower age group between 0 and 4 years and those of PISP or PRSP had the similar tendency. 4. Antibacterial activities were determined for CDTR and related oral antibiotics against the strains of S. pneumoniae and H. influenzae as representative isolates. CDTR had stronger antibacterial activities against both bacteria than the reference antibiotics. CDTR was found to be transferred into the otorrhea at a mean concentration of 0.58 micrograms/ml after single administration of CDTR-PI granule formulation at 3 mg(potency)/kg. 5. As for bacterial eradication efficacies in the middle ear cavity and the nasopharynx, eradication rates were higher than 80% in the middle ear cavity in all cases without large differences among bacterial species but eradication rate of PISP was 30% in the nasopharynx, and it was significantly lower than those of PSSP and other bacteria. 6. In view of clinical effectiveness, the efficacy rate was 89.4% and bacteriological effects was 92.2%; in view of safety, adverse reactions were; observed in 9.5% and the rate of usefulness was 89.4%. 7. From above-stated results, CDTR-PI was considered as a useful oral antibiotic for infantile acute otitis media including PISP infections.