A comparative double-blind study to determine the dosage of NY-198 (Lomefloxacin) in oral and maxillofacial infections

Abstract

In an attempt to define objectively the optimal dosage schedule of NY-198 for infections in the oral surgical field we evaluated the efficacy, safety and usefulness of the compound by a double-blind method in two different dosage groups, 600 mg/day (in 3 divided doses) and 400 mg/day (in 2 divided doses) . These doses had produced the most appropriate results in open clinical trials. The study involved patients with periodontal infections, pericoronitis or osteitis of the jaw. The following results were obtained.
1) Clinical efficacy (Physician's judgement) : There were 58 patients in the 400 mg group and 61 patients in the 600 mg group. The efficacy rates were 75.9% and 86.9%, respectively. When classified by diagnosis, the efficacy rates were 75.9% for the 400 mg group and 96.0% for the 600 mg group for periodontal infections, 66.7% for the 400 mg group and 83.3% for the 600 mg group for pericoronitis, and 82.4% for the 400 mg group and 79.2% for the 600 mg group for osteitis of the jaw. Although there was no significant differences between the two dosage groups, the efficacy rates in the groups with periodontal infection and pericoronitis tended to be higher in the 600 mg group than in the 400 mg group.
2) Clinical efficacy (Judgement based on points) : The efficacy rates for both the 400 mg group (58 patients) and the 600 mg group (61 patients) were similar at 81.0% and 80.3%, respectively. When classified by the diagnosis, the efficacy rates were 86.2% for the 400 mg group and 92.0% for the 600 mg group for periodontal infections, 66.7% for both the 400 mg and 600 mg group with pericoronitis, and 82.4% for the 400 mg group and 75.0% for the 600 mg group for osteitis of the jaw. There were no significant differences between the two dosage groups. Stratified analysis for individual background factors and infection type did not demonstrate any significant difference between the two dosage groups.
3) Safety : Side effects occurred in 3 patients from each of the two dosage groups, while abnormal changes in laboratory data were observed in 1 patient from each of the two dosage groups. There was no significant differences between the two dosage groups.
4) Usefulness: NY-198 was rated as useful in 70.7% for the 400 mg group (58 patients) and 85.5% for the 600 mg group (62 patients) : the compound tended to be more useful in the 600 mg group than in the 400 mg group. It was thus confirmed from these results that NY-198 was more useful for infections in the oral surgical field of the dosage schedule of 200 mg 3 times a day.