Clinical evaluation of roxithromycin in odontogenic orofacial infections

An open multicentre clinical trial was conducted in Japan to study the efficacy and safety of roxithromycin in the treatment of acute odontogenic infections. Specimens were collected by needle aspiration only from closed abscesses. The MICs were determined for the pathogens isolated by an agar dilution method. Before and after administration of roxithromycin, whenever possible, a biological safety evaluation was performed. The drug was orally administered in a dosage of 200-400 mg daily, in two divided doses, before the morning and evening meals. Evaluation was objectively performed in accordance with the 'Evaluation Criteria for the Efficacy of Antibiotics by the Japan Society of Oral Surgeons'. A total of 144 bacterial strains were isolated from 73 of the 193 analysed subjects. The proportion of the strains sensitive to roxithromycin (MIC less than or equal to 3.13 mg/l) was 85.4%. One hundred and ninety three of a total of 216 subjects were included in the final analysis. The efficacy of the drug was assessed to be 85.5%. No dose-dependent difference in the clinical effect was observed. Adverse reactions were mainly gastrointestinal disorder, seen in five of 211 subjects (2.4%), while increased hepatic transaminases were observed in two of 92 subjects (2.2%).