Effectiveness of Prolonged Antibiotic Prophylaxis in Radical Cystectomy: Preliminary Analysis of the MACS Randomized Clinical Trial

IF 1 4区医学 Q4 ONCOLOGY

Bladder Cancer Pub Date : 2024-07-16 DOI:10.3233/blc-240012

Mariya Vladimirovna Berkut, Alexey Michaylovich Belyaev, Tatyana Yurievna Galunova, Nikolay Ivanovich Tyapkin, Sergey Aleksandrovich Reva, Alexander Konstantinovich Nosov

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引用次数: 0

Abstract

BACKGROUND:

Standard 24-hour antibiotic prophylaxis is widely employed to minimize the risk of infection complications within 30 days following radical cystectomy. However, a considerable variety of protocols and drug combinations don’t prevent a high complication rate, ranging from 37 to 67%. This paper presents the interim analysis of the MACS clinical trial, comparing antibiotic prophylaxis regimens by duration.

OBJECTIVE:

To evaluate the rate of infection complications within 30 days following radical cystectomy by comparing standard 24-hour antibiotic prophylaxis (Group A) with a prolonged 120-hour regimen (Group B).

METHODS:

Patients were randomized in a 1 : 1 ratio. The primary endpoint was the evaluation of the frequency of infection complications. The secondary endpoints were the rate of re-administrating antibiotics and the dynamics of the inflammation biomarker.

RESULTS:

A total of 78 patients (85.0% of the sample size) were enrolled (Group A: 40 and Group B: 38). The baseline and perioperative features were balanced between groups. The overall complication rate was higher in Group A (65.0% vs. 41.1%, p = 0.043). The infection complication rate was 2.7 times higher in the standard antibiotic prophylaxis group: 37.5% compared to 18.4% cases in Group B (p = 0.041), and upper urinary tract infection was more frequent in Group A (22.5% vs. 2.6%). The prolonged antibiotic prophylaxis reduced the overall frequency of infection complications compared with standard 24-hour prophylaxis (RR = 0.12; 95% CI 0.02–0.88; p = 0.037).

CONCLUSIONS:

In this interim analysis, the administration of prolonged antibiotic prophylaxis over 120 hours appears to be safe and feasible, demonstrating a reduction in the total number of complications, particularly infection complications.

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根治性膀胱切除术中长期抗生素预防的有效性：MACS随机临床试验的初步分析

摘要背景：为了最大限度地降低根治性膀胱切除术后 30 天内出现感染并发症的风险，广泛采用了标准的 24 小时抗生素预防措施。然而，大量不同的方案和药物组合并不能防止较高的并发症发生率，从37%到67%不等。本文介绍了 MACS 临床试验的中期分析，比较了不同时间段的抗生素预防方案。目的：通过比较标准的 24 小时抗生素预防方案（A 组）和延长的 120 小时方案（B 组），评估根治性膀胱切除术后 30 天内的感染并发症发生率：方法：患者按 1 : 1 的比例随机分组。主要终点是评估感染并发症的发生率。结果：共有 78 名患者（占样本量的 85.0%）入组（A 组 40 人，B 组 38 人）。两组患者的基线和围手术期特征均衡。A 组的总体并发症发生率更高（65.0% 对 41.1%，P = 0.043）。标准抗生素预防组的感染并发症发生率高出 2.7 倍：A组的上尿路感染发生率更高（22.5% 对 2.6%）。与标准的24小时预防相比，延长抗生素预防可降低感染并发症的总发生率（RR = 0.12；95% CI 0.02-0.88；p = 0.037）。结论：在这项中期分析中，使用超过120小时的延长抗生素预防似乎是安全可行的，可减少并发症总数，尤其是感染并发症。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bladder Cancer Medicine-Urology

CiteScore

1.60

自引率

0.00%

发文量

期刊介绍： Bladder Cancer is an international multidisciplinary journal to facilitate progress in understanding the epidemiology/etiology, genetics, molecular correlates, pathogenesis, pharmacology, ethics, patient advocacy and survivorship, diagnosis and treatment of tumors of the bladder and upper urinary tract. The journal publishes research reports, reviews, short communications, and letters-to-the-editor. The journal is dedicated to providing an open forum for original research in basic science, translational research and clinical medicine that expedites our fundamental understanding and improves treatment of tumors of the bladder and upper urinary tract.