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多中心、随机、对照临床试验:经尿道输尿管镜碎石术与体外冲击波碎石术,哪种是治疗儿童远端输尿管结石的最佳微创方式?

A multicenter, randomized, controlled trial of transureteral and shock wave lithotripsy--which is the best minimally invasive modality to treat distal ureteral calculi in children?

机构信息

Urology and Nephrology Research Center (UNRC), Shahid Labbafinejad Medical Center, Shahid Beheshti University, M. C. (SBMU), Tehran, I. R. Iran.

出版信息

J Urol. 2010 Sep;184(3):1106-9. doi: 10.1016/j.juro.2010.05.021. Epub 2010 Jul 21.

Abstract

PURPOSE

Since there is insufficient evidence to determine the best treatment modality in children with distal ureteral calculi, we designed a multicenter, randomized, controlled trial to evaluate the efficacy and complications of transureteral and shock wave lithotripsy in these patients.

MATERIALS AND METHODS

A total of 100 children with distal ureteral calculi were included in the study. Of the patients 50 were randomized consecutively to undergo shock wave lithotripsy using a Compact Delta II lithotriptor (Dornier MedTech, Kennesaw, Georgia), and 50 were randomized to undergo transureteral lithotripsy with holmium laser and pneumatic lithotriptor between February 2007 and October 2009. Stone-free, complication and efficiency quotient rates were assessed in each group.

RESULTS

Mean +/- SD patient age was 6.5 +/- 3.7 years (range 1 to 13). Mean stone surface was 35 mm(2) in the transureteral group and 37 mm(2) in the shock wave lithotripsy group. Stone-free rates at 2 weeks after transureteral lithotripsy and single session shock wave lithotripsy differed significantly, at 78% and 56%, respectively (p = 0.004). With 2 sessions of shock wave lithotripsy the stone-free rate increased to 72%. Efficiency quotient was significantly higher for transureteral vs shock wave lithotripsy (81% vs 62%, p = 0.001). Minor complications were comparable and negligible between the groups. Two patients (4%) who underwent transureteral lithotripsy sustained a ureteral perforation.

CONCLUSIONS

In the short term it seems that transureteral and shock wave lithotripsy are acceptable modalities for the treatment of distal ureteral calculi in children. However, transureteral lithotripsy has a higher efficacy rate when performed meticulously by experienced hands using appropriate instruments.

摘要

目的

由于目前尚无充分证据来确定治疗儿童远端输尿管结石的最佳方法,我们设计了一项多中心、随机、对照试验,旨在评估体外冲击波碎石术和经尿道输尿管镜碎石术治疗这些患者的疗效和并发症。

材料和方法

本研究共纳入 100 例远端输尿管结石患儿。其中 50 例患者连续随机分组接受 Compact Delta II 碎石机(Dornier MedTech,佐治亚州肯尼索)体外冲击波碎石治疗,50 例患者随机分组接受钬激光联合气压弹道碎石机行经尿道输尿管镜碎石治疗。评估两组的无石率、并发症发生率和效率商数。

结果

患者的平均年龄为 6.5 ± 3.7 岁(1~13 岁)。经尿道组结石表面积的平均值为 35mm²,体外冲击波碎石组为 37mm²。经尿道碎石术后 2 周和单次体外冲击波碎石术的无石率分别为 78%和 56%(p=0.004),行 2 次体外冲击波碎石术的无石率增加至 72%。经尿道碎石术的效率商数明显高于体外冲击波碎石术(81%比 62%,p=0.001)。两组的轻微并发症发生率相似,且差异无统计学意义。行经尿道碎石术的 2 例患者(4%)发生输尿管穿孔。

结论

短期内,经尿道碎石术和体外冲击波碎石术似乎都是治疗儿童远端输尿管结石的可行方法。但是,在经验丰富的医生使用适当的器械仔细操作下,经尿道碎石术的疗效更高。

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