Comparative Clinical Study of Ofloxacin and Cefaclor in Bacterial Bronchitis

Abstract

The clinical efficacy and safety of ofloxacin (OFLX; DL-8280) and cefaclor (CCL) were compared bya double-blind study using 250 patients with bacterial bronchitis. Patients were orally administered witheither 200 mg of OFLX or 250 mg of CCL three times a day for 14 days, and the following results wereobtained.1) Clinical efficacy judged by committee:The efficacy rate of acute bronchitis was 86.7% in OFLX group and 85.7% in CCL group. On theother hand, 78.4% of the patients in OFLX group and 50.0% of those in CCL group were effective inchronic bronchitis group. Statistically significant difference was observed between OFLX group andCCL group in chronic bronchitis group (p°0.001).2) Clinical efficacy judged by the doctors in charge:The results of the clinical efficacy judged by the doctors in charge was similar to the efficacy judgedby committee.3) Bacteriological efficacy judged by committee:Eradication rate of OFLX group was 90.2%(55 of 61 strains) and that of CCL group was 50%(35 of70 strains) (p°0.001). Furthermore, H influenzae and K pneumoniae were eliminated in a higher rate inOFLX group than in CCL group (p°0.001, p°0.05, respectively).4) Side effects and abnormal laboratory findings:Side effects were observed in 10 cases (8.1%) in OFLX group and in 10 cases (8.4%) in CCL group.Both OFLX and CCL did not show serious side effects or abnormal laboratory findings. There was nosignificant difference bwtween the two drug groups in the incidence of side effects and abnormallaboratory findings.5) Clinical utility:When the clinical utility was expressed by the satisfaction rate (very satisfied and satisfied), it was75.7% in OFLX group (107 patients) and 52.7% in CCL group (110 patients) (judged by committee).When the utility was judged by doctors in charge, it was 68.9% in OFLX group and 43.0% in CCL group.Both results revealed that OFLX was significantly superior to CCL (p°0.001).From these results, it was confirmed that OFLX was a more useful drug than CCL for the treatmentof bacterial bronchitis.