Prospective, randomized, multicentric, open, comparative study on the efficacy of a prophylactic single dose of 500 mg levofloxacin versus 1920 mg trimethoprim/sulfamethoxazole versus a control group in patients undergoing TUR of the prostate
Prospective, randomized, multicentric, open, comparative study on the efficacy of a prophylactic single dose of 500 mg levofloxacin versus 1920 mg trimethoprim/sulfamethoxazole versus a control group in patients undergoing TUR of the prostate
复制标题
DOI：
10.1016/j.eururo.2005.01.004
复制
发表时间：
2005-04-01
期刊：
影响因子：
23.4
通讯作者：
Naber, KG
中科院分区：
文献类型：
--
作者：
Wagenlehner, FME;Wagenlehner, C;Naber, KG
目的：经尿道前列腺电切术（TUR-P）是最常见的泌尿外科手术之一。在一项多中心研究中，研究了接受TUR-P的患者中预防性单剂量左氧氟沙星与甲氧苄啶/磺胺甲恶唑（TMP/SMZ）与对照组（未接受抗生素预防）的疗效。目的是评估TUR-P术后5 ~ 7天和3 ~ 5周菌尿（cfu ≥ 10（4）/ml）的发生率以及术后并发症。入选患者中无菌尿（cfu < 10（4）/ml），拟行TUR-P，4天内未接受抗生素治疗。患者按照2：2：1随机化接受500 mg左氧氟沙星或320/1600 mg TMP/SMZ口服单次剂量预防性治疗或不接受预防性治疗。术前、术后5 ~ 7天和术后3 ~ 5周进行患者临床检查和尿培养。结果：德国14个泌尿外科中心共招募了400例患者。376例患者在第5 - 7天可评价，339例患者在第3 - 5周可评价。第5 - 7天的总体菌尿率为22%（左氧氟沙星21%; TMP/SMZ 20%;对照组30%）。第3 ~ 5周菌尿率为28%（左氧氟沙星26%; TMP/SMZ 26%;对照组36%）。3 ~ 5周并发症发生率为10%（左氧氟沙星8%; TMP/SMZ 10%;对照组16%）。各中心的术后菌尿发生率差异很大（0%-75%）。统计学显著性（p < 0.05）菌尿（范围）的风险因素为外科医生的资质（19%-37%）、耻骨上导管的存在（22%-34%）、闭合引流系统的断开（25%-52%）、手术时间（12%-31%）和手术中心（0%-75%）。对照组的抗生素总消耗量（用于预防和治疗）高于抗生素预防组（6.9 vs. 5.0剂量/患者; 24.9欧元vs. 19.7欧元/患者）（p < 0.0001）。菌尿患者术后并发症（CFN ≥ 10（4）/ml）的发生率高于非菌尿性（cfu < 10（4）/ml）患者（17% vs. 8%）（p < 0.01）。术后菌尿是否是确定TUR-P患者抗菌预防有效性的关键参数尚有争议。然而，与术后并发症的总体发生率密切相关。因此，通过预防措施降低菌尿发生率似乎是合理的。由于未接受抗生素预防的患者最终接受的抗生素剂量甚至比接受预防的患者更多，因此抗生素使用的总体选择压力显然不能通过放弃预防来降低。因此，我们得出结论，至少有风险的患者应该接受抗生素预防TUR-P之前。（c）2005爱思唯尔B. V.保留所有权利。
Objectives: Transurethral resection of the prostate (TUR-P) is one of the most frequent urological procedures. The efficacy of a prophylactic single dose of levofloxacin vs. trimethoprim/sulfamethoxazole (TMP/SMZ) vs. a control group, receiving no antibiotic prophylaxis, in patients undergoing TUR-P was investigated in a multicentre study. The aims were to assess the rate of bacteriuria (cfu >= 10(4)/ml) 5 to 7 days, and 3 to 5 weeks after TUR-P, as well as postoperative complications.Methods: The study was prospective, randomized, multicentric, open and comparative. Patients without bacteriuria (cfu < 10(4)/ml) scheduled for TUR-P and not having received antibiotics prior within four days were enclosed. Patients received an oral single dose prophylaxis with either 500 mg levofloxacin, or 320/1600 mg TMP/SMZ, or no prophylaxis according to a 2:2:1 randomization. Clinical examination of the patients and urine culture were performed prior to, 5 to 7 days and 3 to 5 weeks after TUR-P.Results: 14 urological centres throughout Germany recruited 400 patients. 376 patients were evaluable until day 5 to 7, 339 until week 3 to 5. Overall bacteriuria rate at day 5 to 7 was 22% (levofloxacin 21%; TMP/SMZ 20%; control group 30%). Bacteriuria rate at week 3 to 5 was 28% (levofloxacin 26%; TMP/SMZ 26%; control group 36%). Complication rate at week 3 to 5 was 10% (levofloxacin 8%; TMP/SMZ 10%; control group 16%). The rates of postoperative bacteriuria ranged widely between centers (0%-75%). Statistically significant (p < 0.05) risk factors for bacteriuria (range) were qualification of surgeon (19%-37%), presence of a suprapubic catheter (22%-34%), disconnection of the closed drainage system (25%-52%), operating time (12%-31%) and operative centre (0%-75%). Total antibiotic consumption (for prophylaxis and treatment) in the control group was higher and more expensive than in groups with antibiotic prophylaxis (6.9 vs. 5.0 doses/patient; 24.9 Euro vs. 19.7 Euro/patient) (p < 0.0001). Postoperative complications in patients with bacteriuria (cfn >= 10(4)/ml) were more frequent than in non bacteriuric (cfu < 10(4)/ml) patients (17% vs. 8%) (p < 0.01).Conclusions: It is debatable whether postoperative bacteriuria is the key parameter to define efficacy of antimicrobial prophylaxis in patients undergoing TUR-P. The rate of bacteriuria, however, correlated well with the overall rate of postoperative complications. Therefore, it seems reasonable to lower the rate of bacteriuria by prophylaxis. Since patients without antibiotic prophylaxis received at the end even more antibiotic doses than patients with prophylaxis, the overall selection pressure by antibiotic usage can obviously not be lowered by resigning prophylaxis. Therefore we conclude that at least patients at risk should receive antibiotic prophylaxis prior to TUR-P. (c) 2005 Elsevier B.V. All rights reserved.