经尿道前列腺切除术的抗菌预防：一项随机试验的结果。

Antimicrobial Prophylaxis in Transurethral Resection of the Prostate: Results of a Randomized Trial.

机构信息

Associatie Urologie Hageland, Tielt-Winge, Belgium.

U Hasselt, Hasselt, Belgium.

出版信息

J Urol. 2021 Jun;205(6):1748-1754. doi: 10.1097/JU.0000000000001638. Epub 2021 Feb 9.

DOI:10.1097/JU.0000000000001638

PMID:33560163

Abstract

PURPOSE

We sought to determine whether omitting antimicrobial prophylaxis is safe in patients undergoing transurethral resection of the prostate without preoperative pyuria and a preoperative catheter.

MATERIALS AND METHODS

We conducted a multicenter randomized controlled trial from September 17, 2017 until December 31, 2019 in 5 hospitals. Patients with pyuria (>100 white blood cells/ml) and a preoperative indwelling catheter were excluded. Postoperative fever was defined as a body temperature ≥38.3C. A noninferiority design was used 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 (antimicrobial prophylaxis group) - E (no antimicrobial prophylaxis group) ≥ Δ (6% noninferiority margin). A multivariable, logistic regression was performed regarding posttransurethral resection of the prostate fever and antimicrobial prophylaxis with co-variates: (clot-)retention and operating time. The R Project® for statistical computing was used and a p value of 0.05 was considered as statistically significant.

RESULTS

Of the patients 474 were included for multivariable analysis and 211/474 (44.5%) received antimicrobial prophylaxis vs 263/474 (55.5%) patients without antimicrobial prophylaxis. Antibiotics were fluoroquinolones in 140/211 (66.4%), cephazolin in 58/211 (27.5%) and amikacin in 13/211 (6.2%) patients. Fever occurred in 9/211 (4.4%) patients with antimicrobial prophylaxis vs 13/263 (4.9%) without antimicrobial prophylaxis (p=0.8, risk difference 0.006 [95% CI -0.003-0.06, relative risk 1.16]). We were able to exclude a meaningful increase in harm associated with omitting antimicrobial prophylaxis (p=0.4; adjusted risk difference 0.016 [95% CI -0.02-0.05]).

CONCLUSIONS

Our data demonstrate the safety of omitting antimicrobial prophylaxis in patients undergoing transurethral resection of the prostate without preoperative pyuria and a preoperative indwelling catheter.

摘要

目的

我们旨在确定在没有术前脓尿和术前留置导尿管的情况下，接受经尿道前列腺切除术的患者中，是否可以安全地省略抗菌预防。

材料和方法

我们于 2017 年 9 月 17 日至 2019 年 12 月 31 日在 5 家医院进行了一项多中心随机对照试验。排除有脓尿（>100 个白细胞/ml）和术前留置导尿管的患者。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）为实验组（E）的感染风险至少比对照组（C）高 6%；H0：C（抗菌预防组）-E（无抗菌预防组）≥Δ（6%非劣效性边界）。使用多变量逻辑回归分析经尿道前列腺切除术发热与抗菌预防的相关性，并对混杂因素（凝块保留和手术时间）进行了调整。使用 R 项目®进行统计计算，p 值<0.05 被认为具有统计学意义。

结果

在纳入多变量分析的 474 例患者中，211 例（44.5%）接受了抗菌预防，而 263 例（55.5%）患者未接受抗菌预防。211 例患者中，抗生素分别为氟喹诺酮类 140 例（66.4%）、头孢唑林 58 例（27.5%）和阿米卡星 13 例（6.2%）。抗菌预防组有 9/211（4.4%）例患者出现发热，而未抗菌预防组有 13/263（4.9%）例患者出现发热（p=0.8，风险差异 0.006[95%CI-0.003-0.06，相对风险 1.16]）。我们能够排除与省略抗菌预防相关的显著危害增加（p=0.4；调整后的风险差异 0.016[95%CI-0.02-0.05]）。