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西洛多辛预防输尿管鞘置入致输尿管损伤:一项随机对照试验。

Silodosin for Prevention of Ureteral Injuries Resulting from Insertion of a Ureteral Access Sheath: A Randomized Controlled Trial.

机构信息

Department of Urology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.

Department of Pediatrics, AjouUniversity Hospital, Ajou University School of Medicine, Suwon, Republic of Korea.

出版信息

Eur Urol Focus. 2022 Mar;8(2):572-579. doi: 10.1016/j.euf.2021.03.009. Epub 2021 Mar 23.

DOI:10.1016/j.euf.2021.03.009
PMID:33741297
Abstract

BACKGROUND

The ureteral access sheath (UAS) is an ancillary device widely used by urologists, but acute ureter injury may occur following its insertion. Preoperative selective oral α1-blockers can reduce intraureteral pressure, and prevent ureteral wall injury during UAS insertion.

OBJECTIVE

To compare perioperative data of patients who underwent flexible ureterorenoscopy (fURS) with UAS with and without premedication with silodosin.

DESIGN, SETTING, AND PARTICIPANTS: Single-blind, 100 patients from a single institution who underwent retrograde intrarenal surgery for kidney and upper ureter stone removal were prospectively allocated from May 2018 to March 2019.

INTERVENTION

The experimental groups received silodosin for 3 d preoperatively.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary endpoint included ureteral injuries after UAS insertion that were assessed according to endoscopic classification. The secondary endpoint was an evaluation of whether premedication with silodosin had any effect on postoperative outcomes.

RESULTS AND LIMITATIONS

A total of 44 and 43 patients were randomly assigned to the control and experimental groups, respectively. Silodosin prevented significant postoperative ureteral injury involving the smooth muscle layer more successfully than in the control group (9.3% vs 27.3%; p = 0.031). There was no significant difference in the overall complication rate as determined by the modified Clavien-Dindo classification system and the computed tomography scan stone-free rate postoperatively. Patients who received silodosin before fURS reported lower pain scores than those in the control group using a visual analog scale (p = 0.009). Limitation included a lack of placebo comparison.

CONCLUSIONS

Our data suggest that preoperative silodosin protects against significant ureteral injury related to UAS insertion during fURS and decreases postoperative pain level. Silodosin premedication might be an effective and safe technique to replace prestenting.

PATIENT SUMMARY

We investigated the preventive effect of an α-blocker against perioperative complication caused by ureteral access sheath inserted during flexible ureterorenoscopy. Taking silodosin before surgery prevented ureter wall injury during surgery and immediately improved postoperative pain.

摘要

背景

输尿管通道鞘(UAS)是泌尿科医生广泛使用的辅助设备,但在插入 UAS 后可能会发生急性输尿管损伤。术前选择性口服α1-阻滞剂可降低输尿管内压,防止 UAS 插入过程中输尿管壁损伤。

目的

比较接受输尿管软镜检查(fURS)联合 UAS 治疗的患者,以及在术前使用西洛多辛预给药的患者围手术期数据。

设计、地点和参与者:单盲,2018 年 5 月至 2019 年 3 月,100 例来自单家机构的患者前瞻性分配,他们因肾结石和上段输尿管结石接受逆行肾内手术。

干预措施

实验组术前接受西洛多辛治疗 3 天。

观察指标和统计分析

主要终点包括根据内镜分类评估 UAS 插入后输尿管损伤情况。次要终点是评估西洛多辛预给药对术后结果的影响。

结果和局限性

共有 44 例和 43 例患者分别随机分配到对照组和实验组。与对照组相比,西洛多辛更成功地预防了涉及平滑肌层的显著术后输尿管损伤(9.3% vs 27.3%;p = 0.031)。改良 Clavien-Dindo 分类系统和术后 CT 扫描结石清除率评估的总体并发症发生率无显著差异。接受 fURS 前使用西洛多辛的患者与对照组相比,使用视觉模拟量表(VAS)报告的疼痛评分较低(p = 0.009)。局限性包括缺乏安慰剂对照。

结论

我们的数据表明,术前西洛多辛可预防 fURS 期间 UAS 插入引起的显著输尿管损伤,并降低术后疼痛水平。西洛多辛预给药可能是一种有效且安全的技术,可以替代预扩张。

患者总结

我们研究了α阻断剂对输尿管软镜检查时插入输尿管通道鞘引起的围手术期并发症的预防作用。术前服用西洛多辛可防止手术期间输尿管壁损伤,并立即改善术后疼痛。

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