Department of Urology, Strong Memorial Hospital, University of Rochester, Medical Center, Rochester, NY.
Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY.
Urol Oncol. 2019 Mar;37(3):181.e7-181.e14. doi: 10.1016/j.urolonc.2018.10.029. Epub 2018 Dec 14.
To evaluate the role of antibiotic prophylaxis with oral ciprofloxacin prior to urinary catheter removal after radical prostatectomy in preventing urinary tract infection (UTI).
Patients undergoing radical prostatectomy were prospectively enrolled and randomized to either the antibiotic prophylaxis group (2 doses of oral ciprofloxacin prior to urinary catheter removal) or the control group (no antibiotics given prior to urinary catheter removal). Neither patients nor study providers were blinded to the group. The primary objective was to assess for development of UTI. The secondary objective was to assess for development of Clostridium difficile (C diff) enterocolitis. Continuous variables were compared using a 2-sample t test. Categorical variables were compared using Pearson's chi-squared test or Fisher's exact test.
One hundred seventy-five patients were enrolled and randomized (90 control and 85 antibiotic prophylaxis). After randomization, 4 patients were excluded and 4 patients withdrew voluntarily. One hundred sixty-seven patients (84 control and 83 antibiotic prophylaxis) completed the study and were available for analysis. There were no significant differences in baseline characteristics, perioperative data, or complications. There was no significant difference in the rate of UTI between the control group and antibiotic prophylaxis group (5.95% vs. 6.02%, P = 1). There was also no significant difference in the rates of C diff infection between the control and the antibiotic prophylaxis groups (3.57% vs. 0%, P = 0.21).
In this prospective, randomized, controlled trial, the use of antibiotic prophylaxis with oral ciprofloxacin prior to urinary catheter removal after radical prostatectomy did not decrease the rate of UTI, and was not associated with an increased incidence of C diff enterocolitis.
评估在根治性前列腺切除术后拔除导尿管前口服环丙沙星预防尿路感染(UTI)的作用。
前瞻性纳入接受根治性前列腺切除术的患者,并随机分为抗生素预防组(拔除导尿管前口服环丙沙星 2 剂)或对照组(拔除导尿管前不给抗生素)。患者和研究提供者均未对组进行盲法。主要目的是评估 UTI 的发生情况。次要目的是评估艰难梭菌(C diff)结肠炎的发生情况。连续变量采用两样本 t 检验进行比较。分类变量采用 Pearson 卡方检验或 Fisher 确切检验进行比较。
共纳入 175 例患者并进行随机分组(90 例对照组和 85 例抗生素预防组)。随机分组后,4 例患者被排除,4 例患者自愿退出。167 例患者(84 例对照组和 83 例抗生素预防组)完成了研究并可进行分析。两组患者的基线特征、围手术期数据或并发症均无显著差异。对照组和抗生素预防组的 UTI 发生率无显著差异(5.95% vs. 6.02%,P=1)。对照组和抗生素预防组的 C diff 感染率也无显著差异(3.57% vs. 0%,P=0.21)。
在这项前瞻性、随机、对照试验中,在根治性前列腺切除术后拔除导尿管前使用口服环丙沙星进行抗生素预防并不能降低 UTI 的发生率,也不会增加 C diff 结肠炎的发生率。