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电液压与电磁体外冲击波碎石机有效性及安全性的前瞻性随机对照研究

Prospective randomized comparative study of the effectiveness and safety of electrohydraulic and electromagnetic extracorporeal shock wave lithotriptors.

作者信息

Sheir Khaled Z, Madbouly Khaled, Elsobky Emad

机构信息

Urology and Nephrology Center, Mansoura University, Egypt.

出版信息

J Urol. 2003 Aug;170(2 Pt 1):389-92. doi: 10.1097/01.ju.0000075080.58359.46.

Abstract

PURPOSE

We compared the efficacy of 2 shock wave energy sources, electrohydraulic (Dornier MFL 5000, Dornier MedTech, Wessling, Germany) and electromagnetic (DLS, Dornier Lithotriptor S, Dornier MedTech), for the treatment of urinary calculi.

MATERIALS AND METHODS

A prospective randomized study of 694 patients with urinary stones was conducted during 12 months to compare the efficacy of the 2 machines. Entrance criteria were radiopaque single or multiple stones at any location within the kidney or the ureter, 25 mm or smaller that had not previously been treated by any means. Patients with congenital anomalies were excluded from this study with all other contraindications for extracorporeal shock wave lithotripsy. Following lithotripsy a plain abdominal film and tomograms were done 1 week after each session to determine if there were residual stones and assess the need for re-treatment. Patients were evaluated 4 weeks after lithotripsy by plane abdominal x-ray and spiral computerized tomography. Success was defined as no residual stones. Univariate and multivariate statistical analyses were performed for different variables that may have an impact on the success rate, including the type of lithotriptor. Comparisons of treatment parameters, complications and success rate for both lithotriptors were done.

RESULTS

Of 9 variables examined with univariate analysis 6 had a significant impact on the success rate. Of these 4 maintained their statistical impact on multivariate analysis. These were side, site of the stones, renal morphology and type of lithotriptor. Treatment time was significantly shortened for DLS (54 +/- 32.9 minutes compared to 65.7 +/- 44.7 for MFL, p <0.001). The re-treatment rate was lower for DLS at 34% versus 51.6% for the MFL (p <0.001). The overall success rate was 85.4%. It was 88.5% for DLS compared to 82.4% for MFL (p = 0.03). No statistically significant difference between the lithotriptors was noted for ureteral calculi (p >0.05). The success rate was higher in the DLS group for renal stones especially lower caliceal and pyelic stones (p <0.05). The success rate was higher in DLS group for stones 10 mm or smaller, 92.8% versus 85.3% for MFL (p = 0.03). The success rate was comparable in both groups for stones larger than 10 mm (81.8% for DLS versus 77.9% for MFL, p >0.05). No statistically significant difference was found in the complication rate for the groups. Steinstrasse were noted in 4% of patients treated with MFL and 3% of those treated with DLS. Subcapsular hematomas were noted in 2 patients in each group. No procedures after extracorporeal shock wave lithotripsy were needed in either group.

CONCLUSIONS

The electromagnetic lithotriptor (Dornier lithotriptor S) has significant clinical advantages over the electrohydraulic lithotriptor (Dornier MFL 5000) in terms of treatment time, re-treatment rate and success rate, although there is no difference in the complication rate.

摘要

目的

我们比较了两种冲击波能量源,即液电式(德国韦斯林多尼尔医疗技术公司的多尼尔MFL 5000)和电磁式(德国多尼尔医疗技术公司的多尼尔碎石机S型DLS)治疗尿路结石的疗效。

材料与方法

在12个月期间对694例尿路结石患者进行了一项前瞻性随机研究,以比较这两种仪器的疗效。入选标准为肾或输尿管内任何位置的不透X线的单个或多个结石,直径25 mm或更小,且此前未接受过任何治疗。患有先天性异常的患者以及所有其他体外冲击波碎石术的禁忌症患者被排除在本研究之外。碎石术后,每次治疗1周后进行腹部平片和断层扫描,以确定是否有残留结石并评估再次治疗的必要性。碎石术后4周通过腹部X线平片和螺旋计算机断层扫描对患者进行评估。成功定义为无残留结石。对可能影响成功率的不同变量进行单因素和多因素统计分析,包括碎石机类型。对两种碎石机的治疗参数、并发症和成功率进行了比较。

结果

单因素分析检测的9个变量中有6个对成功率有显著影响。其中4个在多因素分析中保持其统计学影响。这些因素是侧别、结石部位、肾脏形态和碎石机类型。DLS的治疗时间显著缩短(54±32.9分钟,而MFL为65.7±44.7分钟,p<0.001)。DLS的再次治疗率较低,为34%,而MFL为51.6%(p<0.001)。总体成功率为85.4%。DLS为88.5%,而MFL为82.4%(p = 0.03)。两种碎石机治疗输尿管结石的差异无统计学意义(p>0.05)。DLS组肾结石尤其是下盏和肾盂结石的成功率较高(p<0.05)。DLS组10 mm或更小结石的成功率较高,为92.8%,而MFL为85.3%(p = 0.03)。两组中大于10 mm结石的成功率相当(DLS为81.8%,MFL为77.9%,p>0.05)。两组的并发症发生率差异无统计学意义。接受MFL治疗的患者中有4%出现石街,接受DLS治疗的患者中有3%出现石街。每组各有2例患者出现肾包膜下血肿。两组患者体外冲击波碎石术后均无需进一步处理。

结论

电磁式碎石机(多尼尔碎石机S型)在治疗时间、再次治疗率和成功率方面比液电式碎石机(多尼尔MFL 5000)具有显著的临床优势,尽管并发症发生率无差异。

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