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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

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【作者】 苗佳梁德荣文崇林杨斌江南林建梅

【Author】 MIAO Jia,LIANG De-rong,WEN Cong-lin,et al. (1.Institute of Clinical Pharmacology, West China Hospital, Sichuan University, Chengdu 610041; 2.The Third People’s Hospital of Chengdu City, Chengdu 610030; 3.Sichuan Provincial People’s Hospital,Chengdu 610072)

【机构】 四川大学华西医院国家药品临床研究基地成都市第三人民医院四川省人民医院四川省人民医院 四川成都610041四川成都610041四川成都610030四川成都610072四川成都610072

【摘要】 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。

【Abstract】 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.

  • 【文献出处】 华西医学 ,West China Medical Journal , 编辑部邮箱 ,2004年02期
  • 【分类号】R691.3
  • 【被引频次】8
  • 【下载频次】55
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