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输尿管软镜与体外冲击波碎石术治疗5-15毫米肾结石的疗效比较:一项随机对照试验的结果

Effectiveness of Flexible Ureterorenoscopy Versus Extracorporeal Shock Wave Lithotripsy for Renal Calculi of 5-15 mm: Results of a Randomized Controlled Trial.

作者信息

Fankhauser Christian Daniel, Weber Damian, Müntener Michael, Poyet Cedric, Sulser Tullio, Hermanns Thomas

机构信息

Department of Urology, University Hospital, University of Zurich, Zurich, Switzerland.

出版信息

Eur Urol Open Sci. 2021 Feb 2;25:5-10. doi: 10.1016/j.euros.2021.01.001. eCollection 2021 Mar.

Abstract

BACKGROUND

Primary flexible ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (SWL) are treatment options in patients with renal calculi of 5-15 mm.

OBJECTIVE

To compare effectiveness, complication rates, and pain scores between primary URS and SWL.

DESIGN SETTING AND PARTICIPANTS

Between 2011 and 2016, patients with renal calculi between 5 and 15 mm were randomized to undergo either primary URS or SWL.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Stone-free rate and size of residual fragments assessed by computed tomography after 3 mo, complications, and pain scores were evaluated.

RESULTS AND LIMITATIONS

The study was prematurely closed after randomizing 44 patients due to poor accrual. The 3-mo stone-free rate and mean residual stone size were, respectively, 61% and 1.8 mm after URS and 48% and 2.4 mm after SWL. Early post-treatment pain scores were significantly higher after URS than after SWL on day 1 (3.3 vs 1.6,  =  0.02) and day 7 (5.2 vs 3.4,  =  0.04), but were no longer detectable after 3 wk and 3 mo, respectively. One Clavien-Dindo grade II complication was observed after URS (5%) and SWL (4%), while one (4%) grade IIIb complication was observed after SWL.

CONCLUSIONS

URS appears to be associated with higher early post-treatment discomfort, which could be associated with routine postoperative stenting. Owing to premature closure of this trial, the power was insufficient to formally compare URS and SWL; however, the present data might be informative to counsel patients about treatment outcomes and allow future meta-analyses.

PATIENT SUMMARY

This study was ended prematurely, but it contributes data about efficacy and side effects of different treatment options in patients with renal calculi.

摘要

背景

对于直径5 - 15毫米的肾结石患者,初次软性输尿管肾镜检查(URS)和体外冲击波碎石术(SWL)均为治疗选择。

目的

比较初次URS和SWL的有效性、并发症发生率及疼痛评分。

设计、地点与参与者:2011年至2016年期间,将直径5至15毫米的肾结石患者随机分为两组,分别接受初次URS或SWL治疗。

结果测量与统计分析

评估3个月后通过计算机断层扫描测定的结石清除率、残余碎片大小、并发症及疼痛评分。

结果与局限性

由于入组情况不佳,在随机分配44例患者后该研究提前终止。URS治疗后3个月的结石清除率和平均残余结石大小分别为61%和1.8毫米,SWL治疗后分别为48%和2.4毫米。治疗后早期疼痛评分在第1天(3.3对1.6,P = 0.02)和第7天(5.2对3.4,P = 0.04)时,URS组显著高于SWL组,但在3周和3个月后分别不再可检测到。URS组(5%)和SWL组(4%)各观察到1例Clavien-Dindo II级并发症,SWL组观察到1例(4%)IIIb级并发症。

结论

URS似乎与治疗后早期更高的不适相关,这可能与常规术后支架置入有关。由于该试验提前终止,检验效能不足以正式比较URS和SWL;然而,目前的数据可能有助于为患者提供有关治疗结果的信息,并为未来的荟萃分析提供参考。

患者总结

本研究提前结束,但提供了不同治疗方案对肾结石患者疗效和副作用的数据。

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