加替沙星注射液治疗急性尿路感染的多中心随机对照临床研究

A Multicenter Randomized Controlled Clinical Study of Gatifloxacin Injection in the Treatment of Acute Urinary Tract Infections

目的 :评价国产加替沙星注射液治疗急性尿路感染的临床疗效与安全性。方法 :以左氟沙星注射液为对照 ,采用多中心随机对照试验设计 ,两药均为 2 0 0mg静脉滴注 ,Q12h,疗程 7～ 10日。结果 :加替沙星组与左氟沙星组的痊愈率和总有效率分别为 6 5 79%与 83 33%和 94 74 %与 97 6 2 % ,细菌清除率分别为 87 88%和96 77% ,不良反应发生率分别为 9 30 %和 8 89% ,以上结果两组间比较差异均无统计学意义。两组不良反应均主要为轻度恶心、呕吐、失眠、局部刺激及肝功转氨酶增高。结论 :国产加替沙星注射液治疗急性尿路感染疗效确切 ,安全性较好。

Objective:To evaluate the clinical efficacy and safety of domestic gatifloxacin injection in the treatment of acute urinary tract infections. Methods: A multicenter randomized controlled clinical study was conducted comparing with levofloxacin injection. The dosage of of the two drugs was 200mg, ivgtt, twice daily. The duration of treatment was 7 to 10 days in both groups. Results: The cure rates and total effective rates were 65.79% and 94.74% in the gatifloxacin group, and 83.33% and 97.62% in the lexofloxacin group respectively. The bacterial eradication rates of the two groups were 87.88% and 96.77% respectively. The adverse reaction rates were 9.30% and 8.89% respectively, including mild nausea, vomiting, agrypnia, local stimulation and transaminase increasing. No significant differences in the above figures between the two groups. Conclusion: Domestic gatifloxacin injection is effective and safe in the treatment of acute urinary tract infections.