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一项比较改良 HM3 与 MODULITH® SLX-F2 碎石机的前瞻性随机试验。

A prospective randomised trial comparing the modified HM3 with the MODULITH® SLX-F2 lithotripter.

机构信息

Department of Urology, University of Bern, Bern, Switzerland.

出版信息

Eur Urol. 2011 Apr;59(4):637-44. doi: 10.1016/j.eururo.2011.01.026. Epub 2011 Jan 25.

DOI:10.1016/j.eururo.2011.01.026
PMID:21296481
Abstract

BACKGROUND

The relative efficacy of first- versus last-generation lithotripters is unknown.

OBJECTIVES

To compare the clinical effectiveness and complications of the modified Dornier HM3 lithotripter (Dornier MedTech, Wessling, Germany) to the MODULITH(®) SLX-F2 lithotripter (Storz Medical AG, Tägerwilen, Switzerland) for extracorporeal shock wave lithotripsy (ESWL).

DESIGN, SETTING AND PARTICIPANTS: We conducted a prospective, randomised, single-institution trial that included elective and emergency patients.

INTERVENTIONS

Shock wave treatments were performed under anaesthesia.

MEASUREMENTS

Stone disintegration, residual fragments, collecting system dilatation, colic pain, and possible kidney haematoma were evaluated 1 d and 3 mo after ESWL. Complications, ESWL retreatments, and adjuvant procedures were documented.

RESULTS AND LIMITATIONS

Patients treated with the HM3 lithotripter (n=405) required fewer shock waves and shorter fluoroscopy times than patients treated with the MODULITH(®) SLX-F2 lithotripter (n=415). For solitary kidney stones, the HM3 lithotripter produced a slightly higher stone-free rate (p=0.06) on day 1; stone-free rates were not significantly different at 3 mo (HM3: 74% vs MODULITH(®) SLX-F2: 67%; p=0.36). For solitary ureteral stones, the stone-free rate was higher at 3 mo with the HM3 lithotripter (HM3: 90% vs MODULITH(®) SLX-F2: 81%; p=0.05). For solitary lower calyx stones, stone-free rates were equal at 3 mo (63%). In patients with multiple stones, the HM3 lithotripter's stone-free rate was higher at 3 mo (HM3: 64% vs MODULITH(®) SLX-F2: 44%; p=0.003). Overall, HM3 lithotripter led to fewer secondary treatments (HM3: 11% vs MODULITH(®) SLX-F2: 19%; p=0.001) and fewer kidney haematomas (HM3: 1% vs. MODULITH(®) SLX-F2: 3%; p=0.02).

CONCLUSIONS

The modified HM3 lithotripter required fewer shock waves and shorter fluoroscopy times, showed higher stone-free rates for solitary ureteral stones and multiple stones, and led to fewer kidney haematomas and fewer secondary treatments than the MODULITH(®) SLX-F2 lithotripter. In patients with a solitary kidney and solitary lower calyx stones, results were comparable for both lithotripters.

摘要

背景

目前尚不清楚第一代和最后一代碎石机的相对疗效。

目的

比较改良的多尼尔 HM3 碎石机(多尼尔医疗技术公司,德国韦斯林)与 MODULITH(®) SLX-F2 碎石机(STORZ 医疗公司,瑞士泰格伦)在体外冲击波碎石术(ESWL)中的临床效果和并发症。

设计、地点和参与者:我们进行了一项前瞻性、随机、单机构试验,纳入了选择性和急诊患者。

干预措施

在麻醉下进行冲击波治疗。

测量

在 ESWL 后 1 天和 3 个月评估结石碎裂、残留碎片、收集系统扩张、绞痛和可能的肾血肿。记录并发症、ESWL 再治疗和辅助治疗。

结果和局限性

接受 HM3 碎石机治疗的患者(n=405)需要的冲击波次数和透视时间比接受 MODULITH(®) SLX-F2 碎石机治疗的患者(n=415)少。对于单个肾结石,HM3 碎石机在第 1 天的结石清除率略高(p=0.06);3 个月时结石清除率无显著差异(HM3:74% vs MODULITH(®) SLX-F2:67%;p=0.36)。对于单个输尿管结石,HM3 碎石机的 3 个月结石清除率较高(HM3:90% vs MODULITH(®) SLX-F2:81%;p=0.05)。对于单个下盏结石,3 个月时结石清除率相等(63%)。对于多发性结石患者,HM3 碎石机的 3 个月结石清除率较高(HM3:64% vs MODULITH(®) SLX-F2:44%;p=0.003)。总体而言,HM3 碎石机导致的二次治疗较少(HM3:11% vs MODULITH(®) SLX-F2:19%;p=0.001),肾血肿也较少(HM3:1% vs. MODULITH(®) SLX-F2:3%;p=0.02)。

结论

改良的 HM3 碎石机需要的冲击波次数和透视时间更少,对单个输尿管结石和多发性结石的结石清除率更高,导致肾血肿和二次治疗的发生率也更低。对于单个肾结石和单个下盏结石患者,两种碎石机的结果相当。

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