Pimentel F L, Dolgner A, Guimarães J, Quintas M, Mário-Reis J
Serviços de Medicina, Hospital São João-Porto, Portugal.
J Chemother. 1998 Apr;10(2):122-7. doi: 10.1179/joc.1998.10.2.122.
Norfloxacin 400 mg twice-a-day has proven to be effective and safe in the treatment of uncomplicated urinary tract infections (UTI). Since previous pharmacokinetic studies demonstrate the feasibility of using norfloxacin 800 mg once-daily, and this scheme is assumed to improve patient compliance, a double-blind randomized clinical trial was performed to compare the efficacy and safety of norfloxacin 800 mg once-daily (Group A) versus norfloxacin 400 mg twice-daily (Group B) in the treatment of adult female UTI for a 7-10 day period. Eighty-six adult women with clinical symptoms and urinary sediment signs suggestive of UTI were enrolled. In Group A, treatment was clinically assessed as effective in 95.3% and bacteriologically effective in 92.0% of the patients. In Group B, clinical and bacteriological efficacy was 100% and 95.5%, respectively. Differences between groups are not statistically significant. Adverse events were reported by 14.0% of patients in Group A and 9.6% in Group B (difference not statistically significant). There was one withdrawal due to dizziness. In this study, norfloxacin 800 mg once-a-day was as effective and safe as norfloxacin 400 mg twice-a-day in the treatment of uncomplicated urinary tract infections in women.
已证实，诺氟沙星400毫克每日两次治疗单纯性尿路感染（UTI）有效且安全。鉴于先前的药代动力学研究表明，每日一次服用800毫克诺氟沙星是可行的，且该方案有望提高患者的依从性，因此开展了一项双盲随机临床试验，比较每日一次服用800毫克诺氟沙星（A组）与每日两次服用400毫克诺氟沙星（B组）治疗成年女性UTI 7至10天的疗效和安全性。86名有临床症状及尿沉渣迹象提示UTI的成年女性参与了研究。A组中，95.3%的患者临床评估有效，92.0%的患者细菌学评估有效。B组的临床和细菌学有效率分别为100%和95.5%。两组间差异无统计学意义。A组14.0%的患者和B组9.6%的患者报告了不良事件（差异无统计学意义）。有1例因头晕退出研究。在本研究中，每日一次服用800毫克诺氟沙星与每日两次服用400毫克诺氟沙星治疗女性单纯性尿路感染的疗效和安全性相当。
