化膿性中耳炎に対する Fosfomycin (FOM) の薬効評価試験成績

Pipemidic acid(PPA)との二重盲検比較試験

抄録

A multi-clinical, double blind controlled study was carried out to evaluate objectively the efficacy of fosfomycincalcium (FOM) against suppurative otitis media using pipemidic acid (PPA) as a reference drug. Patients received 2g daily of either FOM or PPA in four divided doses by oral administration. Following results were obtained. 1) The efficacy rate of FOM group assessed by physicians in charge was 60.3%, while that of PPA group was 46.2%. When patients were classified into 3 groups (acute otitis media, chronic otitis media and acute exacerbation of chronic otitis media) with respect to diagnosis, statistically significant difference in efficacy was observed in the case of acute exacerbation of chronic suppurative otitis media. The efficacy rate of FOM group assessed by the com-mittee was 56.0%, while that of PPA group was 44.6%. 2) The global utility rate of FOM group assessed by physicians in charge was 58.1%, while that of PPA group was 44.4%, statistically significant difference was observed. 3) When the efficacy for acute exacerbation of chronic suppurative otitis media was analysed bacteriologically, eradication rate of FOM group was significantly superior to that of PPA group. 4) In the case of infections due to aerobic gram negative bacteria, no significant difference in the clinical and bacteriological efficacy was observed between FOM group and PPA group. 5) In acute exacerbation of chronic suppurative otitis media, the improvement of discharge from auris media (8 th day) in FOM group was significantly bettor than that of PPA group. 6) No significant difference in the frequency of side effects was observed between the both groups. And the incidence of side effects was transitory changes and no abnormal laboratory findings were observed. 7) Antibacterial activity of FOM against clinical isolates was several times higher than that of PPA. These results suggest that FOM is a new antibiotic which is highly valuable in the treatment of suppurative otitis media.