Vol.52 No.8 August 2004

Clinical study on cefcapene pivoxil in adults with acute odontogenic infection

Akihiro Kaneko and Jiro Sasaki

Department of Oral Surgery, School of Medicine, Tokai University, Boseidai, Isehara, Kanagawa, Japan

Abstract

We studied the efficacy of cefcapene pivoxil (CFPN-PI, trade name: Flomox) against adult infection in dentistry and oral surgery for which oral antibiotics we are used.
1) At 3 primary facilities and 9 secondary medical practice facilities nationwide, CFPN-PI was administered in 146 cases: 84 of periodontitis, 10 of pericoronitis, and 52 of jaw osteitis. The daily dose was 300 mg in 139 and 450 mg in 7 cases.
2) CFPN-PI was effective (judged by the primary physician) in 76 of 84 cases of periodontitis (90.5%), 8 of 10 of pericoronitis (80.0%), and 49 of 52 of jaw osteitis (94.2%), i.e., 133 overall (91.1%). Efficacy was higher at secondary than primary medical facilities at, 93.3% versus 87.7%.
3) Efficacy, by age, was 84.8% in young adults (age: 17 to 45), 92.1% in middle-aged adults (age: 46 to 65), and 97.3% in older adults (age: 66 to 83). Eefficacy by daily dose was 91.4% in the 300 mg/day group and 85.7% in the 450 mg/day group.
4) Efficacy judged on day 3 based on the Evaluation Standards of Antibiotic Efficacy in the Areas of Dentistry and Oral Surgery was 54 of 59 in periodontitis (91.5%), 5 of 7 in pericoronitis (85.7%), and 35 of 38 in jaw osteitis (92.1%), i.e., 95 of 104 overall (91.3%). It was higher at secondary than at primary medical facilities at, 92.9% versus 88.2%.
5) When efficacy was compared to that at the new drug symposium, it was similar at 89.8% compared to 91.1% by the physician's judgment and 91.2% to 91.3% for day 3 judgment.
6) Mild adverse reactions were observed in 2 of 153 cases (1.4%).
Based on these results, we concluded that cefcapene pivoxil is a useful agent for treating odontogenic infection in doses of 300 mg/day.

Key word

oral infection, cefcapene pivoxil, postmarketing clinical study

Received

May 21, 2004

Accepted

June 17, 2004

Jpn. J. Chemother. 52 (8): 416-425, 2004