Berkut Mariya Vladimirovna, Belyaev Alexey Michaylovich, Galunova Tatyana Yurievna, Tyapkin Nikolay Ivanovich, Reva Sergey Aleksandrovich, Nosov Alexander Konstantinovich
FSBI "N.N. Petrov National Medical Research Centre of Oncology" MH of RF, Saint Petersburg, Russia.
Leningrad Regional Clinical Hospital, Saint Petersburg, Russia.
Bladder Cancer. 2024 Oct 23;10(3):221-232. doi: 10.3233/BLC-240012. eCollection 2024.
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.
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).
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.
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%, = 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 ( = 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; = 0.037).
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.
标准的24小时抗生素预防措施被广泛应用，以降低根治性膀胱切除术后30天内感染并发症的风险。然而，相当多的方案和药物组合并不能预防高达37%至67%的高并发症发生率。本文介绍了MACS临床试验的中期分析，比较了不同持续时间的抗生素预防方案。
通过比较标准的24小时抗生素预防（A组）和延长至120小时的方案（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。
患者按1∶1比例随机分组。主要终点是评估感染并发症的发生频率。次要终点是抗生素重新给药率和炎症生物标志物的动态变化。
共纳入78例患者（占样本量 的85.0%）（A组40例，B组38例）。两组间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%， =0.043）。标准抗生素预防组的感染并发症发生率高2.7倍：A组为37.5%，B组为18.4%（ =0.041），且A组上尿路感染更常见（22.5%对2.6%）。与标准的24小时预防相比，延长抗生素预防时间降低了感染并发症的总体发生率（RR=0.12；95%CI 0.02-0.88； =0.037）。
在本次中期分析中，超过120小时的延长抗生素预防给药似乎是安全可行的，并发症总数有所减少，尤其是感染并发症。
