Cefdinirの歯科・口腔外科領域感染症に対する基礎的・臨床的検討

抄録

Clinical studies of Cefdinir (CFDN : FK 482) in the treatment of infections in the oral surgery were evaluated, and the antibacterial activities of CFDN against oral streptococci were determined. These results were obtained as follows :
1. Against 125 strains of oral streptococci MIC₅₀ and MIC₉₀ of CFDN were 0.05μg/ml and 0.2μg/ml, respectively. The antibacterial activity of CFDN was equal to that of Cefpodoxime and Cefroxime.
2. CFDN was orally adiministered to a total of 177 patients in a dose of 100 mg or 200 mg t, i. d.. The subjects consisted of the patients with periodontitis (Group I), pericoronitis (Group II), and osteitis of the jaw (Group III) . 174 patients were evaluated for efficacy, and 175 patients were evaluated for safety and usefulness.
The clinical efficacy rate judged by the comparative score evaluated on Day 3 was 90.8 %. While, rate by the investigators was 86.8 %. When these rates were evaluated for each disease group, the efficacy rates by the comparative score evaluated on Day 3 and by the investigators were 91.5 % and 88.1 % in Group I (59 cases), respectively, 87.5 % and 85.0 % in Group II (40 cases) and 92.0 % and 86.7 % in Group III (75 cases), respectively. In clinical efficacy rate based on comparative score evaluated on Day 3 for each dose level, the efficacy rates were high in both the 300 mg group (90.4 %) and 600 mg group (92.1 %) . In patients with high score on the starting day of the treatment, however, efficacy rate in the 600 mg group was somewhat lower than that in the 300 mg group.
3. On the bacteriological effect, eradication rate was 94.3 %.
4. A total of 174 strains of organisms were isolated from patients. (Streptococcus spp.: 87, Peptostreptococcus spp.: 46, Bacteroides spp.: 14 and others : 27)
The MIC₅₀ and MIC₉₀ of CFDN for all the isolates were 0.05 and 0.39 μg/ml, respectively.
5. Adverse events were observed in 7 of the 175 patienst : gastrointestinal tract disorders in 6 and eruption in 1. Abnormal findings in laboratory tests were noted in 7 of the 175 patients. They were an increase in eosinophl (4) and GOT and GPT (1), and GPT (2) . No serious events were seen in any of the patients.
6. Usefulness rate (“useful”or better response) that evaluated by investigators was 86.9 %. From the above results, CFDN was considered to be useful in the treatment of infections in Dentistry and Oral Surgery. As for the standard dose, 100 mg t, i, d, proved to exert the expected effects.