De Sio Marco, Autorino Riccardo, Quarto Giuseppe, Mordente Salvatore, Giugliano Francesco, Di Giacomo Ferdinando, Neri Fabio, Quattrone Carmelo, Sorrentino Domenico, De Domenico Renato, D'Armiento Massimo
Clinica Urologica, AOU Policlinico, Seconda Università degli Studi, Napoli, Italy.
BJU Int. 2007 Nov;100(5):1137-41. doi: 10.1111/j.1464-410X.2007.07039.x. Epub 2007 Jun 5.
To assess the efficacy and safety of a transportable extracorporeal shock wave lithotripsy (ESWL) machine, the Modulith SLX-F2(TM) (Storz Medical Italia, Rome, Italy), in the management of solitary urinary calculi.
The study included 233 patients (mean age 51 years; 172 male, 61 female) with symptomatic solitary renal (group A, 170, mean diameter 15.5 mm) or ureteric stones (group B, 63, mean diameter 9.5 mm) treated in a tertiary care institution. Exclusion criteria for the analysis were: pelvi-ureteric junction obstruction, multiple stones, stone diameter >2 cm, stones in a lower calyx with unfavourable anatomy, active infection, or impacted ureteric stones. Selected patients had ureteric stenting before treatment, and all patients were treated with no anaesthesia. Hospitalization, complications and subsequent auxiliary procedures were evaluated. Patients were assessed after a single ESWL session and after 3 months by a plain abdominal film and renal ultrasonography. Stone-free status was defined as no evidence of calculi, and clinical success as the presence of stone fragments of <4 mm. An efficiency quotient (EQ) was calculated for the ESWL treatment. Pain was assessed using a visual analogue scale.
The mean number of shocks used was 3779 and the mean (range) treatment time was 35 (5-55) min. The overall clinical success rate after one ESWL session was 83.7% and 82.5% for renal and ureteric stones, respectively, and the overall 3-month stone-free rate was 77% and 74.6%, respectively; the overall EQ was 0.64. When risk factors for persistent calculi were analysed simultaneously in a logistic regression model, only stones of >1 cm were statistically significant (P < 0.05). Most patients reported that pain during ESWL was mild to moderate and easily tolerated. Only minor complications occurred, with an overall complication rate of 3.8%.
This transportable lithotripter is a safe and effective device for managing solitary stones throughout the urinary tract. Its main advantage is represented by the dual-focus system. Moreover, it shares with other contemporary machines several important features such as outpatient setting, no need for anaesthesia, easy patient positioning, and the capability of ancillary procedures.
评估可移动体外冲击波碎石机(ESWL)Modulith SLX-F2(意大利罗马斯托兹医疗器械公司)治疗孤立性尿路结石的有效性和安全性。
本研究纳入了在一家三级医疗机构接受治疗的233例患者(平均年龄51岁;男性172例,女性61例),这些患者患有有症状的孤立性肾结石(A组,170例,平均直径15.5 mm)或输尿管结石(B组,63例,平均直径9.5 mm)。分析的排除标准为:肾盂输尿管连接处梗阻、多发结石、结石直径>2 cm、下盏结石且解剖结构不利、活动性感染或嵌顿性输尿管结石。入选患者在治疗前进行输尿管支架置入,所有患者均在无麻醉的情况下接受治疗。评估住院情况、并发症及后续辅助程序。单次ESWL治疗后以及3个月后通过腹部平片和肾脏超声对患者进行评估。结石清除状态定义为无结石证据,临床成功定义为存在<4 mm的结石碎片。计算ESWL治疗的效率商(EQ)。使用视觉模拟量表评估疼痛程度。
平均冲击波使用次数为3779次,平均(范围)治疗时间为35(5 - 55)分钟。单次ESWL治疗后,肾结石和输尿管结石的总体临床成功率分别为83.7%和82.5%,总体3个月结石清除率分别为77%和74.6%;总体EQ为0.64。在逻辑回归模型中同时分析持续性结石的危险因素时,仅结石>1 cm具有统计学意义(P < 0.05)。大多数患者报告ESWL治疗期间的疼痛为轻度至中度,易于耐受。仅发生了轻微并发症,总体并发症发生率为3.8%。
这种可移动碎石机是治疗尿路各处孤立性结石的安全有效设备。其主要优势在于双焦点系统。此外,它与其他当代设备具有一些共同的重要特征,如门诊治疗、无需麻醉、患者体位摆放容易以及具备辅助程序的能力。