Cefmenoxime (CMX) 耳用液の慢性化膿性中耳炎および慢性化膿性中耳炎急性増悪症に対する二重盲検比較試験成績

抄録

In order to evaluate the clinical of and safety of Cefmenoxime (CMX) otic solution on purulent otitis media, a double blind clinical test was carried out by means of topical administration of CMX otic solution and placebo respectively to the patients with chronic purulent otitis media and its acute exacerbatins. Cefalexin was orally administered as basic treatment. Both 90 patients treated with CMX otic solution and 90 patients with placebo were subjected to the clinical evaluation. The effectiveness rate including “remarkably effective” and “effective” observed in CMX group by the judgement of chief physicians was 75.6%, while placebo group showed 41.1% of effectiveness rate (p≤0.001). By the judgement of the committee member, however, 75.6% effectiveness rate was obtained in CMX group and 37.8% in placebo group respectively (p≤0.01), and thus, the clinical efficacy of CMX otic solution was confirmed statistically. With respect to the bacteriological efficacy judged by the committee member, CMX otic solution exerted an antibacterial effect on S. aureus and P. aeruginosa and the total bacteria eradication rate was 71.4% with CMX and 38.0% with placebo, the significant difference being observed between the two groups (p≤0.001). As to the safety of CMX otic solution, side effects were observed in 3 cases among 100 patients treated with CMX otic solution (3.0%) and also in 3 cases among 97 placebo treated patients (3.1%). All the side effects observed were transient and not severe at all. CMX otic solution was confirmed, therefore, to be a highly tolerable and safe preparation. It is concluded that, based on the above clinical test results, 1% CMX otic solution which possessed an excellent antibacterial activity, is quite an efficacious and safe topical preparation for the treatment of purulent otitis media.