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目的 :评价国产加替沙星注射液治疗急性细菌性呼吸道和泌尿道感染的有效性与安全性。方法 :采用区组随机、平行对照、多中心研究设计 ,加替沙星注射液与左氧氟沙星注射液均为 2 0 0mg ,ivd ,q12h ,疗程 5～ 14d。 结果 :本项试验实际入组 4 9例 ,其中加替沙星组 2 7例 ,左氧氟沙星组 2 2例 ,治疗结果加替沙星与左氧氟沙星组临床有效率分别为 96 .30 %与95 .4 5 % ,细菌清除率分别为 95 .2 4 %与 10 0 % ,不良反应发生率分别为 7.4 1%与 4 .5 5 % ,上述结果均无统计学差异。结论 :加替沙星与左氧氟沙星在治疗临床常见的敏感细菌引起的呼吸道、泌尿道感染均是安全、有效的抗菌药物。
Objective: To evaluate the efficacy and safety of domestic gatifloxacin injection in the treatment of acute bacterial respiratory and urinary tract infections. Methods: Randomized, parallel controlled and multi-center study design was adopted. Gatifloxacin injection and levofloxacin injection were 200 mg, ivd and q12h respectively, and the course of treatment was 5 to 14 days. Results: In this trial, 49 patients were actually enrolled. Among them, 27 patients in gatifloxacin group and 22 patients in levofloxacin group had clinical efficacy rates of 96.3% and 95.4% for gatifloxacin and levofloxacin, respectively 5%, bacterial clearance rate was 95.24% and 100%, the incidence of adverse reactions were 7.41% and 4.55%, the above results were no significant difference. Conclusion: Gatifloxacin and levofloxacin are safe and effective antibacterial agents in the treatment of respiratory and urinary tract infections caused by common sensitive bacteria in clinic.