| Objective: To evaluate the clinical safety and efficacy of gatifloxacin tablets in the treatment of acute bacterial infections.Method: By the randomized, double blind and active parallel controlled means, 220 patients with mild to moderate acute infections of the respiratory and urinary systems were divided into two groups. 110 patients were treated ;with gatifloxacin tablets, 0.2 g, po, bid ; 7 14 days, the other 110 patients were treated with ofloxacin tablets, 0.2 g, po, bid for 7 14 days.Result: 203 patients have completed the trial, 103 in the gatifloxacin group and 100 in the ofloxacin group. In the per protocol analysis, the clinical cure rates of the gatifloxacin group and the ofloxacin group were 76.7% and 71.0% ; the total effective rates being 93.2% ; and 85.0% . The bacterial clearance rates were 96.7% and 93.8% respectively. In the intent to treat analysis, the adverse reaction rates were 16.4% and 18.2% , respectively. There were respectively 5 ( 4.55% ) and 9 ( 8.18% ) abnormality of laboratory examinations of the ALT or AST associated with gatifloxacin group and ofloxacin group. All of these adverse reactions were mild, and they were recovered 10 days after stopping the drugs.Conclusion: Gatifloxacin is a potent antibiotic agent and can be recommended to treat the mild to moderate a cute infections of the respiratory and urinary systems. |
