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≤2厘米肾结石的软性输尿管肾镜检查与冲击波碎石术:一项随机对照试验

Flexible Ureterorenoscopy Versus Shockwave Lithotripsy for Kidney Stones ≤2 cm: A Randomized Controlled Trial.

作者信息

Bosio Andrea, Alessandria Eugenio, Dalmasso Ettore, Agosti Simone, Vitiello Federico, Vercelli Eugenia, Bisconti Alessandro, Gontero Paolo

机构信息

Department of Urology, Città della Salute e della Scienza, Molinette University Hospital, Turin, Italy.

Department of Urology, Città della Salute e della Scienza, Molinette University Hospital, Turin, Italy.

出版信息

Eur Urol Focus. 2022 Nov;8(6):1816-1822. doi: 10.1016/j.euf.2022.04.004. Epub 2022 Apr 22.

DOI:10.1016/j.euf.2022.04.004
PMID:35466071
Abstract

BACKGROUND

No clear recommendations are available on whether retrograde intrarenal surgery (RIRS) via flexible ureterorenoscopy or shockwave lithotripsy (SWL) should be preferred for kidney stones ≤2 cm, except for lower-pole stones.

OBJECTIVE

To compare outcomes between RIRS and SWL.

DESIGN, SETTING, AND PARTICIPANTS: This was a single-center randomized controlled trial from March 2015 to May 2018. Patients with a single 6-20-mm kidney stone were enrolled (NCT02645058).

INTERVENTION

Patients were randomized to RIRS or SWL.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary endpoint was the single-procedure stone-free rate (SFR) at 1 mo. Two levels of success were set: fragments ≤4 mm (SFR-4) and no residual fragments (SFR-0). Secondary endpoints were the SFR at 6 mo and 1 yr and rates of complications and further treatments.

RESULTS AND LIMITATIONS

A total of 138 patients underwent treatment (70 RIRS vs 68 SWL). In comparison to SWL, RIRS SFR results were higher at 1 mo (SFR-4 70.0% vs 45.6%; p = 0.004; SFR-0 50.0% vs 26.5%; p = 0.004) and 6 mo (SFR-4 79.7% vs 63.6%; p = 0.038; SFR-0 59.4% vs 40.9%; p = 0.032). There was no difference in SFR measures between the groups at 1 yr (SFR-4 p = 0.322; SFR-0 p = 0.392). Overall complications were comparable (p = 0.207), but the complication rate for stones >10 mm was higher for the SWL group (p = 0.021). The need for further treatment was comparable (p = 0.368). In terms of patient satisfaction, 86.8% and 77.1% of patients would choose SWL and RIRS again, respectively (p = 0.24).

CONCLUSIONS

RIRS achieved better SFRs in comparison to SWL at 1 and 6 mo, but not at 1 yr. The RIRS complication rate was lower for stones >10 mm. SWL remains a viable alternative, especially for 6-10-mm stones, providing comparable results to RIRS in the long term.

PATIENT SUMMARY

We compared outcomes for the treatment of kidney stones ≤2 cm with two techniques: flexible ureteroscopy, in which a flexible telescope is passed through the urethra and bladder to reach the ureter between the bladder and kidney; and shockwave lithotripsy, in which shockwaves are applied to the skin over the location of the kidney stone. Ureteroscopy achieved better stone-free results at 1 and 6 months, but not at 1 year.

摘要

背景

除了下极结石外,对于直径≤2cm的肾结石,采用软性输尿管肾镜逆行肾内手术(RIRS)还是冲击波碎石术(SWL)更优,目前尚无明确的推荐意见。

目的

比较RIRS和SWL的治疗效果。

设计、地点和参与者:这是一项于2015年3月至2018年5月开展的单中心随机对照试验。纳入了患有单个6-20mm肾结石的患者(NCT02645058)。

干预措施

患者被随机分为RIRS组或SWL组。

结局测量和统计分析

主要终点是1个月时的单次手术无石率(SFR)。设定了两个成功水平:结石碎片≤4mm(SFR-4)和无残留碎片(SFR-0)。次要终点是6个月和1年时的SFR以及并发症和进一步治疗的发生率。

结果与局限性

共有138例患者接受了治疗(70例接受RIRS,68例接受SWL)。与SWL相比,RIRS在1个月时的SFR结果更高(SFR-4为70.0%对45.6%;p = 0.004;SFR-0为50.0%对26.5%;p = 0.004)以及6个月时(SFR-4为79.7%对63.6%;p = 0.038;SFR-0为59.4%对40.9%;p = 0.032)。两组在1年时的SFR测量结果无差异(SFR-4,p = 0.322;SFR-0,p = 0.392)。总体并发症发生率相当(p = 0.207),但SWL组中结石>10mm的并发症发生率更高(p = 0.021)。进一步治疗的需求相当(p = 0.368)。在患者满意度方面,分别有86.8%和77.1%的患者会再次选择SWL和RIRS(p = 0.24)。

结论

与SWL相比,RIRS在1个月和6个月时的SFR更高,但在1年时并非如此。对于结石>10mm,RIRS的并发症发生率更低。SWL仍然是一种可行的选择,特别是对于6-10mm的结石,从长期来看与RIRS的效果相当。

患者总结

我们比较了两种治疗直径≤2cm肾结石的技术的效果:软性输尿管镜检查,即通过尿道和膀胱插入软性望远镜以到达膀胱和肾脏之间的输尿管;以及冲击波碎石术,即将冲击波作用于肾结石所在位置的皮肤。输尿管镜检查在1个月和6个月时取得了更好的无石效果,但在1年时并非如此。

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