Savoca G, Raber M, Lissiani A, Plaino F, Ciampalini S, Buttazzi L, Belgrano E
Department of Urology, University of Trieste, Italy.
Arch Ital Urol Androl. 2000 Apr;72(1):15-20.
The aim of this prospective clinical trial was to compare the efficacy of rufloxacin, a once-daily fluoroquinolone administered as a single pre-operative dose versus the perioperative prophylaxis with ciprofloxacin in transurethral surgery. Two hundred and two patients undergoing transurethral resection of bladder tumors (132) or transurethral resection of the prostate (70) were selected for the study between January 1997 and June 1998. Patients were randomized to two treatment groups. Group A received a single oral 200 mg dose of rufloxacin three hours before surgery and group B was administered oral ciprofloxacin 250 mg bid until catheter removal. The two treatment groups were homogeneous with respect to patient characteristics. One hundred and seventy-three patients (89 rufloxacin and 84 ciprofloxacin) were assessed and 29 were excluded from the statistical analysis. The incidence of postoperative infection was similar in both treatment groups (5.7% rufloxacin, 4.7% ciprofloxacin). On the other hand, single-dose pre-operative prophylaxis with rufloxacin significantly reduced the cost of antibiotic prophylaxis. Results of the present study show that single dose oral rufloxacin may be used in routine clinical practice as a preoperative prophylactic antibiotic due to its low cost, its documented efficacy and its simple once daily dosage regimen.
这项前瞻性临床试验的目的是比较芦氟沙星(一种每日一次的氟喹诺酮类药物,术前单次给药)与环丙沙星在经尿道手术中的围手术期预防效果。1997年1月至1998年6月期间,选择了202例接受膀胱肿瘤经尿道切除术(132例)或前列腺经尿道切除术(70例)的患者进行研究。患者被随机分为两个治疗组。A组在手术前3小时口服200mg芦氟沙星单次剂量,B组口服环丙沙星250mg,每日两次,直至拔除导尿管。两个治疗组在患者特征方面具有同质性。对173例患者(89例芦氟沙星组和84例环丙沙星组)进行了评估,29例被排除在统计分析之外。两个治疗组术后感染发生率相似(芦氟沙星组为5.7%,环丙沙星组为4.7%)。另一方面,术前单次剂量使用芦氟沙星预防可显著降低抗生素预防成本。本研究结果表明,由于其成本低、疗效有记录且每日给药方案简单,口服单剂量芦氟沙星可在常规临床实践中用作术前预防性抗生素。