甲磺酸加替沙星片治疗急性细菌性感染多中心临床研究

A randomized comparative study on the effect of gatifloxacin andciprofloxacin in the treatment of acute bacterial infections

目的 :评价国产甲磺酸加替沙星片的疗效及安全性。方法 :试验组 115例患者接受甲磺酸加替沙星片 2 0 0mg口服 ,每日 2次 ;对照组 10 8例接受盐酸环丙沙星片 2 5 0mg ,每日 3次 ,疗程 7d～ 14d。结果 :试验组与对照组总痊愈率分别为 90 .4 %与77.8% ,有显著性差异 (χ2 =6 .74 ,P <0 .0 1) ;总有效率分别为 95 .7%与 89.8% ,无显著性差异 (χ2 =2 .85 ,P >0 .0 5 )。在呼吸系统、泌尿系统与皮肤软组织轻、中度细菌感染中 ,试验组与对照组的痊愈率、有效率比较均无显著性差异 (P >0 .0 5 ) ;在生殖道感染中 ,试验组痊愈率显著高于对照组 (χ2 =6 .72 ,P <0 .0 1) ,有效率相似 (χ2 =3.0 5 ,P >0 .0 5 )。试验组与对照组各种致病菌感染的痊愈率分别为 90 .3%与 79.6 % ,有显著性差异 (χ2 =4 .4 6 ,P <0 .0 5 ) ;有效率分别为 95 .1%与 90 .3% ,两者相似(χ2 =1.71,P >0 .0 5 ) ;细菌清除率分别为 97.1%与 89.2 % ,有显著性差异 (χ2 =4 .85 ,P <0 .0 5 )。两组不良反应发生率分别为 13.8%和 13.9% (P >0 .0 5 )。结论 :国产甲磺酸加替沙星片治疗轻、中度急性细菌感染安全、高效。

Objective:To evaluate the clinical efficacy and safety of gatifloxacin in the treatment of mild and moderate bacterial infections of respiratory tract,urinary tract,genital tract,skin and soft tissues.Methods:115 patients in study group were treated with gatifloxacin 200mg taken orally q12h,and 108 patients in control group were treated with ciprofloxacin 250mg taken orally q8h for 7days to 14 days.Results:The total cure rates of study group and control group were 90.4% and 77.8%( P <0.01),respectively.The bacterial positive of study group and control group were 89.6%(103/115) and 86.1%(93/108)( P >0.05),respectively.The bacterial eradication rates of the two groups were 97.1% and 89.2%( P <0.05),respectively.Sensitivity rates of 196 bacterial strains to gatifloxacin,ciprofloxacin,levofloxacin,sipafloxacin,cefataxime and penicillin(for gonococcus) were 100%,94.9%,96.9%,89.8%,87.8%,100%,respectively.The differences in bacterial sensitivity rates between gatifloxacin and ciprofloxacin,levofloxacin,sipafloxacin,cefataxime were significant ( P <0.05).Adverse events were generally mild,and adverse events rates of the two groups were 13.8% and 13.9%( P >0.05),respectively.Conclusion:Gatifloxacin is a highly effective and well tolerated antibacterial agent for treatment of acute bacterial infections of respiratory tract,urinary tract,genital tract,skin and soft tissues.