Clinical evaluation of Cefditoren pivoxil (ME 1207) in the treatment of oral infections

Abstract

The clinical efficacy and safety of ME1207 as a treatment for odontogenic infections such as periodontitis, pericoronitis and osteitis was evaluated in 9 institutions.
The results were as follows :
1) Clinical efficacy :
The overall clinical efficacy rate determined according to the standards established by the Committee was 84.0 %. By disease, the efficacy rates were 76.5 %, 76.9 % and 97.1 % for periodontitis, pericoronitis and osteitis, respectively. The overall efficacy rate assessed by the doctors in charge was 83.0 % and the efficacy rates by diagnosis were 76.5 %, 88.5 % and 85.3 % for periodontitis, pericoronitis and osteitis, respectively.
2) Bacteriological response :
The MIC₅₀ and MIC₉₀ of ME1207 against 100 clinically isolated strains were 0.10 and 0.78 μg/ml, respectively. For 53 aerobes strains, the MIC₅₀ and MIC₉₀ were 0.10 and 0.20 μg/ml. Against 36 strains of oral streptococci, the range of MIC were from ≤0.025 to 0.20 μg/ml.
The MIC₅₀ and MIC₉₀ against 47 strains of anaerobes were 0.10 and 0.78 μg/ml, respectively. The eradication rate against infecting organisms from 46 patients were 73.9 % as judged by old criteria.
3) Safety :
Mild side effects occurred in 6 (6.3%) of the 96 patients treated and slightly abnormal laboratory findings were found in 2 (3.1%) of 64 patients examined.