A randomized controlled clinical study on a new quinolone,gatifloxacin, in the treatment of respiratory tract infections

Objective:To evaluate the safety and efficacy of domestic intravenous gatifloxacin in the treatment of respiratory tract infections.Methods:A multicenter,double-blind,randomized controlled clinical trials of intravenous gatifloxacin and levofloxacin on patients with respiratory tract infections were conducted.The regimen of the two groups were 0.2g,twice daily,7～14days.Both drugs were given intravenously.Results:In this trial,40 patients were enrolled in gatifloxacin group,39 patients were enrolled in levofloxacin group.The overall efficacy rates and cure rate in trial and control group were 95%,65% and 94.87%,64.1% respectively.The bacterial clearance rates were 86.8% and 81.1% respectively in two groups.The adverse drug reaction rates were 7.5% and 10.2% in trial and control group respectively.There were no statistically significant differences in the above results between the two groups.The activity of gatifloxacin against gram-positive organisms was generally higher than that of the other 4 antibacterial agents.Antibacterial activity of gatifloxacin against gram-negtive bacterium was similar or stronger than the other antibacterial agents.Conclusion:The results suggest that domestic gatifloxacin injection with powerful antibacterial activity and wide spectrum is a highly effective and safe broad-spectrum new quinolone in treating respiratory tract infections.