Associatie Urologie Hageland, Kapellekensweg 10, Kessel-Lo, Belgium.
U Hasselt, Martelarenlaan 45, 3050, Hasselt, Belgium.
World J Urol. 2021 Oct;39(10):3839-3844. doi: 10.1007/s00345-021-03694-6. Epub 2021 Apr 11.
To determine whether omitting antimicrobial prophylaxis (AMP) in TURB is safe in patients undergoing TURB without an indwelling pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture.
A multi-centered randomized controlled trial (RCT) from 17-09-2017 to 31-12-2019 in 5 hospitals. Patients with a pre-operative indwelling catheter/DJ-stent or nephrostomy and a positive pre-operative urinary culture (> 10 uropathogens/mL) were excluded. Post-operative fever was defined as body temperature ≥ 38.3 °C. A non-inferiority design with a 6% noninferiority margin and null hypothesis (H0) that the infection risk is at least 6% higher in the experimental (E) than in the control (C) group; H0: C (AMP-group) - E (no AMP-group) ≥ Δ (6% noninferiority margin). A multivariable, logistic regression was performed for AMP and post-TURB fever with covariates: tumor size and (clot-) retention. The R Project for statistical computing was used for statistical analysis and a p value of 0.05 was considered as statistically significant.
459 Patients were included and 202/459 (44.1%) received AMP vs 257/459 (55.9%) without AMP. Fever occurred in 6/202 [2.9%; 95% CI (1.2-6.6%)] patients with AMP vs 8/257 [3.1%; 95% CI (1.5%-6.1%)] without AMP (p = 0.44). Multivariable, logistic regression showed no significant harm in omitting AMP when controlled for (clot-)retention and tumor size (p = 0.85) and an adjusted risk difference in developing post-TURB fever of 0.0016; 95% CI [- 0.029; 0.032].
Our data suggest the safety of omitting AMP in patients undergoing TURB without an indwelling, pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture.
确定在没有术前留置导尿管/肾造瘘管/双 J 管和术前尿培养阴性的 TURB 患者中，省略抗菌预防（AMP）是否安全。
这是一项多中心随机对照试验（RCT），于 2017 年 9 月 17 日至 2019 年 12 月 31 日在 5 家医院进行。排除术前留置导尿管/支架管/肾造瘘管和术前尿培养阳性（>10 个尿路病原体/ml）的患者。术后发热定义为体温≥38.3°C。采用非劣效性设计，非劣效性边界为 6%，零假设（H0）为试验组（E）的感染风险至少比对照组（C）高 6%；H0：C（AMP 组）-E（无 AMP 组）≥Δ（6%非劣效性边界）。采用多变量逻辑回归分析 AMP 和 TURB 后发热的影响因素：肿瘤大小和（血块）残留。使用 R 项目进行统计分析，p 值<0.05 认为具有统计学意义。
共纳入 459 例患者，其中 202/459（44.1%）例患者接受 AMP 治疗，257/459（55.9%）例患者未接受 AMP 治疗。AMP 组有 6/202（2.9%）例患者发生发热，95%CI（1.2%-6.6%）；无 AMP 组有 8/257（3.1%）例患者发生发热，95%CI（1.5%-6.1%）；两组之间无统计学差异（p=0.44）。多变量逻辑回归显示，控制（血块）残留和肿瘤大小后，省略 AMP 无显著危害（p=0.85），TURB 后发热的调整风险差异为 0.0016；95%CI（-0.029；0.032）。
本研究数据表明，在没有术前留置导尿管/肾造瘘管/双 J 管和术前尿培养阴性的 TURB 患者中，省略 AMP 是安全的。
