加替沙星与左氧氟沙星随机双盲对照治疗泌尿系统感染98例

A double-blind, randomized controlled clinical study: gatifloxacin vs levofloxacin in treatment of 98 patients with urinary tract infections

目的 :评价国产加替沙星治疗泌尿道感染的有效性和安全性。方法 :采用多中心随机对照双盲试验。左氧氟沙星为对照药 ,试验组和对照组剂量均为 2 0 0mg ,静脉滴注 ,bid ,疗程 7～ 14d。结果 :试验组与对照组可进行安全性评价者分别有 4 8,5 0例 ;可进行疗效评价者分别有 4 7,5 0例。试验组痊愈率 89%、临床有效率 10 0 %、细菌清除率 89% ;对照组分别为 90 % ,96 % ,85 %。加替沙星对革兰阳性菌体外抗菌活性优于其他几种抗菌药。不良事件的发生率分别为 10 %和 12 % ,2组比较差异均无显著意义 (P >0 .0 5 )。结论 :国产加替沙星对敏感菌引起的泌尿道感染疗效确切 ,安全性好。

AIM:To evaluate the safety and efficacy of domestic gatifloxacin in the treatment of urinary tract infections. METHODS:A multicenter,double-blind,randomized control clinical trial of gatifloxacin and levofloxacin was conducted. Both two groups were treated with gatifloxacin or levofloxacin 200 mg,iv, gtt,bid,for 7-14 d. RESULTS: The patients enrolled into gatifloxacin group and levofloxacin group in the double-blind study were 48,50 respectively. The patients for the efficacy analysis were 47,50 respectively. The overall cured rate,efficacy rate and bacterial clearance rate in trial group were 89 %,100 %,89 % respectively and those in control group were 90 %,96 %,85 % respectively. The activities of gatifloxacin against gram-positive organisms in vitro were generally higher than those of the other antibacterial agents. The adverse reaction rate was 10 %and 12 % in trial and control group respectively. There were no statistical significant differences in the above results between the two groups(P>0.05). CONCLUSION: The results suggest that demostic gatifloxacin is highly effective and safe in the treatment of urinary tract infections.