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辅助性单次上尿路灌注丝裂霉素 C 治疗在上尿路尿路上皮癌腔内治疗后的前瞻性单中心非随机试验

Adjuvant Single-Dose Upper Urinary Tract Instillation of Mitomycin C After Therapeutic Ureteroscopy for Upper Tract Urothelial Carcinoma: A Single-Centre Prospective Non-Randomized Trial.

机构信息

Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.

Department of Clinical Sciences and Community Health, Urology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.

出版信息

J Endourol. 2020 May;34(5):573-580. doi: 10.1089/end.2019.0750. Epub 2020 Apr 16.

Abstract

To address the safety and feasibility of adjuvant single-dose upper urinary tract instillation of mitomycin (ASDM) immediately after therapeutic ureteroscopy for upper tract urothelial carcinoma (UTUC) and to compare urothelial (ipsilateral or bladder) recurrence rates in the ASDM group and controls. Between April 2015 and August 2018, 52 patients affected by UTUC were treated by endoscopic ablation, of whom 26 were selected for ASDM. Clinical and perioperative data and 30-day complications were recorded. Urothelial recurrence-free survival (URFS) was evaluated with second-look ureteroscopy (URS) and CT scan/URS every 6 months. ASDM was administered through a Single-J (19/25, 76%) or a Double-J (6/25, 24%) in 25/26 (96%) patients. Median follow-up was 18 months (IQR 10-29). The urothelial recurrence rate was 23.5% and 55.5% in the ASDM group and controls, respectively ( = 0.086). Mean URFS was 28.8 months in the ASDM group 18.8 months in controls (log-rank  = 0.067). On multivariate Cox regression, ASDM was associated with a 7.7-fold lower risk of urothelial recurrence (HR = 0.13; 95% CI 0.03-0.65;  = 0.01). Clavien grade ≤II complications occurred in 32% (8/25) and 30.7% (8/26) of the ASDM and control group, respectively ( = 0.9). Two Clavien III complications occurred in the ASDM group: bladder hematuria after concomitant transurethral resection of bladder and obstructive kidney failure in a single-kidney patient. ASDM was well tolerated after therapeutic URS. It appears to reduce the risk of urothelial recurrence in patients affected by low-grade UTUC without bladder tumor. Therefore, its use should be evaluated.

摘要

为了评估在上尿路尿路上皮癌(UTUC)治疗性输尿管镜检查后即刻辅助单次剂量上尿路灌注丝裂霉素(ASDM)的安全性和可行性,并比较 ASDM 组和对照组的尿路上皮(同侧或膀胱)复发率。在 2015 年 4 月至 2018 年 8 月期间,对 52 例 UTUC 患者进行了内镜消融治疗,其中 26 例患者选择进行 ASDM。记录临床和围手术期数据及 30 天并发症。采用二次输尿管镜检查(URS)和 CT 扫描/URS 每 6 个月评估尿路上皮无复发生存率(URFS)。26 例患者中有 25 例(96%)采用单 J 管(19/25,76%)或双 J 管(6/25,24%)进行 ASDM。中位随访时间为 18 个月(IQR 10-29)。ASDM 组和对照组的尿路上皮复发率分别为 23.5%和 55.5%(=0.086)。ASDM 组的平均 URFS 为 28.8 个月,对照组为 18.8 个月(对数秩检验=0.067)。多变量 Cox 回归分析显示,ASDM 与尿路上皮复发风险降低 7.7 倍相关(HR=0.13;95%CI 0.03-0.65;=0.01)。ASDM 组和对照组分别有 32%(8/25)和 30.7%(8/26)的患者发生 Clavien 分级≤Ⅱ级并发症(=0.9)。ASDM 组有 2 例 Clavien Ⅲ级并发症:1 例合并膀胱肿瘤经尿道切除术和 1 例单肾患者发生阻塞性肾衰竭的膀胱血尿。治疗性 URS 后,ASDM 耐受良好。它似乎可以降低低级别 UTUC 且无膀胱肿瘤患者的尿路上皮复发风险。因此,应该对其进行评估。

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