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SWL、PCNL 和 RIRS 治疗 2cm 以下下盏结石的前瞻性随机对照研究:多中心经验:对下极结石治疗选择的更好理解。

A prospective randomized comparison among SWL, PCNL and RIRS for lower calyceal stones less than 2 cm: a multicenter experience : A better understanding on the treatment options for lower pole stones.

机构信息

Department of Urology, Humanitas Mater Domini, Via Gerenzano 2, 21053, Castellanza, Varese, Italy.

ESUT European Section for UroTechnology, Arnhem, Netherlands.

出版信息

World J Urol. 2017 Dec;35(12):1967-1975. doi: 10.1007/s00345-017-2084-7. Epub 2017 Sep 5.

Abstract

PURPOSE

To prospectively evaluate the efficacy and safety of RIRS, SWL and PCNL for lower calyceal stones sized 1-2 cm.

MATERIALS AND METHODS

Patients with a single lower calyceal stone with an evidence of a CT diameter between 1 and 2 cm were enrolled in this multicenter, randomized, unblinded, clinical trial study. Patients were randomized into three groups: group A: SWL (194 pts); group B: RIRS (207 pts); group C: PCNL (181 pts). Patients were evaluated with KUB radiography (US for uric acid stones) at day 10 and a CT scan after 3 months. The CONSORT 2010 statement was adhered to where possible. The collected data were analyzed.

RESULTS

The mean stone size was 13.78 mm in group A, 14.82 mm in group B and 15.23 mm in group C (p = 0.34). Group C compared to group B showed longer operative time [72.3 vs. 55.8 min (p = 0.082)], fluoroscopic time [175.6 vs. 31.8 min (p = 0.004)] and hospital stay [3.7 vs. 1.3 days (p = 0.039)]. The overall stone-free rate (SFR) was 61.8% for group A, 82.1% for group B and 87.3% for group C. The re-treatment rate was significantly higher in group A compared to the other two groups, 61.3% (p < 0.05). The auxiliary procedure rate was comparable for groups A and B and lower for group C (p < 0.05). The complication rate was 6.7, 14.5 and 19.3% for groups A, B and C, respectively.

CONCLUSIONS

RIRS and PCNL were more effective than SWL to obtain a better SFR and less auxiliary and re-treatment rate in single lower calyceal stone with a CT diameter between 1 and 2 cm. RIRS compared to PCNL offers the best outcome in terms of procedure length, radiation exposure and hospital stay. ISRCTN 55546280.

摘要

目的

前瞻性评估 RIRS、SWL 和 PCNL 治疗 CT 直径 1-2cm 下盏结石的疗效和安全性。

材料和方法

本多中心、随机、非盲、临床试验研究纳入了单枚下盏结石且 CT 直径为 1-2cm 的患者。患者被随机分为三组:A 组:SWL(194 例);B 组:RIRS(207 例);C 组:PCNL(181 例)。患者在第 10 天接受 KUB 射线检查(尿酸结石行 US 检查),3 个月后进行 CT 扫描。尽可能遵循 CONSORT 2010 声明。分析收集的数据。

结果

A 组的平均结石大小为 13.78mm,B 组为 14.82mm,C 组为 15.23mm(p=0.34)。与 B 组相比,C 组的手术时间更长[72.3 比 55.8 分钟(p=0.082)],透视时间更长[175.6 比 31.8 分钟(p=0.004)],住院时间更长[3.7 比 1.3 天(p=0.039)]。A 组的总体结石清除率(SFR)为 61.8%,B 组为 82.1%,C 组为 87.3%。A 组的再次治疗率明显高于其他两组,为 61.3%(p<0.05)。A 组和 B 组的辅助手术率相当,而 C 组较低(p<0.05)。A、B 和 C 组的并发症发生率分别为 6.7%、14.5%和 19.3%。

结论

在 CT 直径 1-2cm 的单枚下盏结石中,RIRS 和 PCNL 比 SWL 更有效,能获得更好的 SFR 和更低的辅助和再次治疗率。与 PCNL 相比,RIRS 在手术时间、辐射暴露和住院时间方面提供了最佳结果。ISRCTN55546280。

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