新喹诺酮类抗菌药加替沙星随机对照治疗呼吸系统感染临床研究

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

目的 :评价国产加替沙星氯化钠注射液治疗呼吸系统感染的有效性与安全性。方法 :采用多中心随机双盲对照试验设计 ,以盐酸左氧氟沙星注射液为对照药 ,试验组和对照组剂量均为每次 2 0 0mg ,每日 2次 ,静脉滴注 ,疗程 7～ 14天。 结果 :试验组 4 0例 ,对照组 39例。试验组与对照组的临床有效率与痊愈率分别为 95 %、6 5 %与 94 .87%、6 4 .1% ,细菌清除率分别为 86 .8%和 81.1% ,不良事件发生率分别为 7.5 %和 10 .2 % ,以上结果统计学均无显著性差异 (P >0 .0 5 )。加替沙星对革兰阳性菌的抗菌活性优于其他几种抗生素 ,对革兰阴性菌的抗菌活性与其他几种抗生素相近或略优。结论 :国产加替沙星抗菌谱广、抗菌活性强 ,是一个高效、安全的抗菌药物 ,治疗呼吸系统感染疗效肯定。

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.