加替沙星和左氧氟沙星治疗急性细菌感染临床研究

目的　本研究以左氧氟沙星为对照药 ,对国产一类新药加替沙星静脉制剂进行临床研究 ,以评价后者的临床疗效与安全性。方法　采用前瞻性、双盲双模拟、随机对照试验设计 ,试验组 40例 ,对照组 3 8例。结果　试验组、对照组的临床有效率分别为 87 5 0 %与 81 5 8% ,细菌学有效率分别为 85 2 9%与 77 42 % ,细菌清除率分别为 88 2 4%与93 5 5 %。试验组与对照组各对应指标差异无统计学意义 (P >0 0 5 )。体外抗菌活性研究结果表明 ,加替沙星的抗菌活性与左氧氟沙星、司帕沙星、氧氟沙星、环丙沙星一致。两组病例的不良反应发生率分别为 13 95 %与 16 67% ,差异无统计学意义 (P >0 0 5 )。不良反应轻微 ,未见严重不良反应。结论　国产一类新药加替沙星静脉制剂作为一种广谱抗菌药 ,抗菌活性较强 ,可安全有效地治疗由敏感菌引起的中、重度细菌感染

Clincial study on gatifloxacin versus levofloxacin

Objective To evaluate the efficacy and safety of gatifloxacin versus levofloxacin. Method A double-blind,double-simulated,block randomized,parallel controlled clinical trials on patients with acute bacterial infections were conducted. 40 patients enrolled in gatifloxacin group,38 patients enrolled in levofloxacin group.Results The efficacy rate in trial and control group were 87.50% and 81.58%,respectively(P>0.05);the bactercial efficacy rate in trial and control group were 85.29% and 77.42%,respectively (P>0.05);the bactercial eradication rate in trial and control group were 88.24% and 93.55%,respectively(P>0.05). The results of vitro susceptibility test showed that gatifloxacin is equal to levofloxacin,sparflocin,ofloxacin and ciprofloxacin. The rate of adverse reactions of gatifloxacin and levofloxacin were 13.95% and 16.67%,respectively(P>0.05). The side effects were mild. Conclusion:The result suggested that gatifloxacin with antibacterial spectrum,satifactory activity,is an effective and safe antibacterial agent in treatment of moderate to severe acute bacterial infections.