Clinical evaluation of cefteram pivoxil in the oral infections

Abstract

To evaluate the clinical efficacy, safety and utility of Cefteram pivoxil (CFTM-PI) in treating odontogenic infections such as periodontal infection, pericoronitis and osteitis of jaw, we carried out clinical study with 11 institutes. CFTM-PI was administered to 208 patients for odontogenic infections and the dosage was 300 mg/day or 600 mg/day divided into three doses. The following results were obtained.
1) Committee evaluation of the clinical efficacy gave efficacy rate of 88.1% for all cases. The committee's efficacy rates by diagnosis were 90.2%, 91.1% and 85.1% for periodontal infection, pericoronitis and osteitis of jaw, respectively. The efficacy rate of the 300mg group and 600mg group, as judged by committee were 84.0% and 89.4%, respectively.
2) The attending physicians gave efficacy rate of 83.3% for all cases.
3) By needle aspiration to avoid contaminating from the oral floras, 161 strains were isolated from closed abscesses of 91 patients. The isolation rates of aerobic gram-positive bacteria, aerobic gramnegative bacteria, anaerobic gram-positive bacteria and anaerobic gram-negative bacteria were 43.5% (70/161 strains), 2.5% (4/161), 45.3% (73/161) and 8.7% (14/161), respectively. The bacteriological response was“eradication of bacteria”in 52 cases, “unchange of bacteria”in one, “unknown of bacteria”in 16 and unknown in 22. The eradication rate judged by committee was 75.4%.
4) Side effects were noted in 2 (1.0%) out of 207 cases and the symptom was diarrhea for one and abdominal pain for another. These symptoms were not serious in degree. Abnormal changes in laboratory findings were found in 8 patients and main symptom of them was elevation of transaminase.