A comparative clinical study on pazufloxacin (PZFX), a new quinolone antibacterial agent, was conducted to determine the optimal dose of PZFX using tosufloxacin (TFLX) as the active control for treatment of chronic respiratory tract infections. Patients with chronic bronchitis or bronchiectasis received orally either a dose of 300mg of PZFX (PZFX-300 group), 600mg of PZFX (PZFX-600 group) or 450mg of TFLX (TFLX group) for 14 days as a rule. All dosages were divided into three administrations per day.
1) Of a total number of 104 patients (36 in PZFX-300 group, 34 in PZFX-600 group and 34 in TFLX group), 94 patients (33, 32 and 29, respectively) were evaluated for clinical efficacy, 100 patients (34, 33 and 33, respectively) for side effects, 89 patients (31, 29 and 29, respectively) for abnormal changes in laboratory parameters, and 95 patients (33, 32 and 30, respectively) for utility. There were no significant differences between the three groups with respect to the numbers of patients for those evaluation and in the distribution of background factors.
2) The clinical efficacy rates were 76% in PZFX-300 group, 91% in PZFX-600 group and 83% in TFLX group with no significant difference among the three groups. In the presence of underlying diseases and/or complications, the efficacy rates were determined to be 95%(20/21) in the PZFX-600 group, 79%(15/19) in the TFLX group, 74%(17/23) in the PZFX-300 group, with a significant difference between the two groups of PZFX (p=0.035).
3) As for the bacteriological effects, the elimination rates were 53%(10/19) in the PZFX-300 group, 81%(13/16) in the PZFX-600 group and 78%(14/18) in the TFLX group, with no significant difference between the three groups.
4) The incidence of side effects was 6% in the PZFX-300 group, 3% for the PZFX-600 group and 6% in the TFLX group. There was no serious adverse reaction. The incidence of abnormal changes in laboratory parameters was 6% in the PZFX-300 group, 7% in the PZFX-600 group and 7% in the TFLX group. All changes were mild in degree. The safety rates were 88%(30/34) in the PZFX-300 group, 91%(30/33) in the PZFX-600 group, 88%(28/32) in the TFLX group with no significant difference between the three groups.
5) The usefulness rates were 70%(23/33) in the PZFX-300 group, 88%(28/32) in the PZFX-600 group and 79%(23/29) in the TFLX group, with no significant difference between the three groups.
The results suggest that a daily dose of 600mg (t. i. d.) is the optimal dose of PZFX of the treatment for the patients with chronic respiratory tract infections.
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