Mirone V, Fusco F, Taglialatela D, Verze P, Di Vito C, Lotti T, Imbimbo C
Department of Urology, University Federico II, Naples, Italy.
J Chemother. 2009 Dec;21(6):651-60. doi: 10.1179/joc.2009.21.6.651.
The aim of this trial was to compare the efficacy and safety of extended-release ciprofloxacin (CIPRO XR) versus the immediate-release formulation (CIPRO IR) in the treatment of complicated urinary tract infections (UTIs). 212 patients were randomized to CIPRO XR 1,000 mg tablet once daily or CIPROXIN IR 500 mg tablet twice daily. Treatment efficacy was evaluated by bacteriological outcome. Safety was measured by recording adverse events. The rate of bacteriological eradication was 83% in the CIPRO XR group and 75% in the CIPRO IR. the overall incidence of adverse events reported was higher in the CIPRO IR group. The authors conclude that CIPRO XR is a safe and effective treatment for complicated UTIs. Although the limited data available do not consent to support a statistically superior efficacy or safety compared to CIPRO IR, a trend in favor of CIPRO XR is clearly evident in all efficacy and safety variables. CIPRO XR is associated with reduced frequencies of drug-related adverse events compared to CIPRO IR.
本试验的目的是比较缓释环丙沙星(CIPRO XR)与速释制剂(CIPRO IR)治疗复杂性尿路感染(UTIs)的疗效和安全性。212名患者被随机分为每日一次服用1000毫克CIPRO XR片或每日两次服用500毫克CIPROXIN IR片。通过细菌学结果评估治疗效果。通过记录不良事件来衡量安全性。CIPRO XR组的细菌根除率为83%,CIPRO IR组为75%。报告的不良事件总发生率在CIPRO IR组更高。作者得出结论,CIPRO XR是治疗复杂性UTIs的一种安全有效的方法。尽管现有有限的数据不支持其在疗效或安全性上在统计学上优于CIPRO IR,但在所有疗效和安全性变量中,明显有利于CIPRO XR的趋势是显而易见的。与CIPRO IR相比,CIPRO XR与药物相关不良事件的发生频率降低有关。