Carmignani G, De Rose A F, Olivieri L, Salvatori E, Rosignoli M T, Dionisio P
Luciano Giuliani Urology Department, University of Genoa, Genoa, Italy.
Urol Int. 2005;74(4):326-31. doi: 10.1159/000084432.
The present study was performed to evaluate the efficacy and safety of a 10-day regimen of prulifloxacin 600 mg once daily as compared to ciprofloxacin 500 mg twice daily in the treatment of patients with complicated urinary tract infections (UTIs).
257 patients (mean age +/- SD 62.3 +/- 16.5) were enrolled and orally treated with prulifloxacin (127 patients) or ciprofloxacin (130 patients). The study was designed as a randomized, double-blind, double-dummy, controlled clinical trial. The primary efficacy parameter was the eradication of infecting strains (<10(3) cfu/ml). The clinical outcome and tolerability were also assessed.
At baseline, the most common infecting strains were Escherichia coli (62.8%), Proteus mirabilis (7.1%) and Klebsiella pneumoniae (4.1%). At the early follow-up, the rate of patients showing successful treatment was 90.8% in the prulifloxacin group, and 77.8% in the ciprofloxacin group (p = 0.008). A positive clinical outcome was observed in 94.8 and 93.3% of prulifloxacin- and ciprofloxacin-treated patients. Both drugs were well tolerated. Two patients dropped out for treatment-related adverse events.
The high urinary concentrations of prulifloxacin, combined with a broad-spectrum antimicrobial activity, allow its use in the empiric therapy of UTIs.
本研究旨在评估每日一次口服600毫克普卢利沙星治疗10天方案与每日两次口服500毫克环丙沙星相比，治疗复杂性尿路感染（UTI）患者的疗效和安全性。
纳入257例患者（平均年龄±标准差62.3±16.5岁），分别接受普卢利沙星（127例患者）或环丙沙星（130例患者）口服治疗。该研究设计为随机、双盲、双模拟、对照临床试验。主要疗效参数为感染菌株清除（<10³cfu/ml）。同时评估临床结局和耐受性。
基线时，最常见的感染菌株为大肠埃希菌（62.8%）、奇异变形杆菌（7.1%）和肺炎克雷伯菌（4.1%）。早期随访时，普卢利沙星组治疗成功的患者比例为90.8%，环丙沙星组为77.8%（p = 0.008）。普卢利沙星和环丙沙星治疗的患者中，临床结局阳性的比例分别为94.8%和93.3%。两种药物耐受性均良好。两名患者因治疗相关不良事件退出研究。
普卢利沙星高尿药浓度与广谱抗菌活性相结合，使其可用于UTI的经验性治疗。
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