抄録
We evaluated whether an outcome could be predicted using a scoring system 3 days after initiating drug administration in the treatment of acute otitis media (AOM). On the post-marketing clinical research of tebipenem pivoxil, we evaluated the associations among the scores at the initiation of drug administration, the variation of the scores from the baseline to 2-4 days afterward, and the judgment of the attending physician (cure/failure) within 3 days after completion or cancellation of the dosage. Compared to patients in whom simple AOM was cured (cure group), the redness scores of the eardrum were significantly higher (P=0.003) at the first visit, a smaller change of the severity scores (P=0.049) and a larger increase of the otorrhea scores were noted (P=0.049) in patients in whom simple AOM was not cured (failure group). In patients with recurrent/persistent otitis media, a tendency similar to that found in simple AOM was observed. According to the variations of the scores for severity or for the tympanic membrane, the patients were classified as having Effectiveness Index (EI) A (decrease of scores >50%) and EI-B (decrease of scores <50%); thus, all patients in the failure group were classified as EI-B. These results suggest that the clinical response to antibiotic therapy for AOM can be predicted to some extent based on whether the patient is EI-A or EI-B at 2-4 days after initiating drug administration. Specifically, the results allowed a change in the treatment method: after measuring the score at 2-4 days after initiating drug administration, patients classified as EI-A would continue to receive the same treatment, whereas in those classified as EI-B a change in the antimicrobial agent should be considered. In other words, the decision of effectiveness based on the variations of the scores was useful to determine the treatment strategy for patients with AOM.
