Oral tissue distribution, efficacy, and safety of sitafloxacin in patients with dentistry and oral surgery infection

• Published in: Japanese Journal of Chemotherapy Vol. 56; no. Supplement1; pp. 121 - 129
• Main Authors: Hori, Seiji, Sasaki, Jiro
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society of Chemotherapy 2008; 公益社団法人 日本化学療法学会
• Subjects: clinical trial; fluoroquinolone; odontogenic infection; sitafloxacin; tissue penetration
• ISSN: 1340-7007; 1884-5886
• DOI: 10.11250/chemotherapy1995.56.Supplement1_121

To assess the fluoroquinolone antibacterial agent sitafloxacin (STFX) for transferability to oral tissue, efficacy, and safety in patients with dentistry and oral surgery infection, we conducted a clinical pharmacology study using STFX at 50mg per single dose and a phase III clinical study using STFX at 50mg or 100mg b. i. d. for 3 to 7 days. 1. Oral tissue concentration 2.7 to 3.7 hours after a single treatment of STFX at 50 mg in 10 cases for data analysis was 0.57±0.17μg/g in gingiva and 0.32±0.17μg/g in extraction wound fluid, making the transfer rate 1.3±0.4 in gingiva and 0.8±0.5 in extraction wound fluid. 2. Clinical efficacy was 97.6%(41/42) rated by doctors in charge, and 85.0%(34/40) by rating ratio based on the Japanese Society of Oral Therapeutics and Pharmacology on day 3 of treatment. 3. Bacteriological elimination was 100%(37/37) at the end of treatment and 94.3%(33/35) on day 3 of treatment. 4. No adverse reactions were seen in the clinical pharmacology study, but occurred in 22 (44.9%, 33 events) of 49 cases for data analysis in the clinical study; none were severe. These results suggest that STFX is well transferred to oral tissues and useful in the treatment of odontogenic infections at a dose of 50 mg b. i. d.