XYS.SUI-6X电磁式体外冲击波碎石机治疗上尿路结石的试验研究  

The Study of Electromagnetic Extracorporeal Shock Wave Lithotripsy (XYS.SUI-6X) in Treating Upper Urinary Calculi

作　　者：杨庆涛[1] 郑俊鸿[1] 周德荣[1] 杨镜秋[1] 黎明[1] 李林芬[1] 陈琳玲[1] 

机构地区：[1]汕头大学医学院第二附属医院,汕头515041

出　　处：《中国医疗器械信息》2012年第8期47-51,62,共6页China Medical Device Information

摘　　要：目的:验证XYS.SUI-6X电磁式体外冲击波碎石机治疗上尿路结石的安全性和有效性。方法:60例肾结石或输尿管结石患者,采用随机、对照的原则,分为验证组和对照组(各30例)。验证组采用深圳市新元素医疗技术开发有限公司生产的XYS.SUI-6X电磁式体外冲击波碎石机进行治疗,对照组采用深圳惠康医疗器械有限公司出品的MZ-ESWL-VI体外冲击波碎石机进行治疗,验证组试验前后进行安全性评价和疗效评价,并与对照组进行疗效对照评价。结果:①验证组治愈率为50%,有效率为40%,无效率10%;对照组治愈率为20%,有效率为70%,无效率10%,验证组疗效优于对照组。②验证组试验前后未引起受试者心电图、肝肾功能、血常规和尿常规的变化。③碎石机的操作性能、稳定性以及显示和控制系统均良好。④在安全性和总体评价方面,验证组出现1例较差的情况,但与对照组相比不具有统计学意义。结论:XYS.SUI-6X电磁式体外冲击波碎石机治疗上尿路结石是安全、有效的,可用于上尿路结石的治疗,但需要进一步改进和完善。Objective： To investigate the safety and efficiency of electromagnetic extracorporeal shock wave lithotripsy （XYS.SUI-6X） treating upper urinary calculi. Methods： 60 patients with renal or ureteral calculi were randomly divided into two groups equally： the experimental group and control group. The experimental group were treated with the electromagnetic extracorporeal shock wave lithotripsy （XYS.SUI-6X）, produced by Shenzhen New Element Medical Ltd.,Co., while the control group were treated with extracorporeal shock wave lithotripsy （MZ-ESWL-VI） produced by Shenzhen Huikang Medical Apparatus Co., Ltd. The Safety and efficacy were evaluated in the experimental group before and after testing, and the efficacy were compared between the experimental group and control group. Results： The cure rate, effective rate and ineffective rate for the experimental group is 50%, 40% and 10% respectively, and for control group, 20%, 70% and 10%, suggesting that efficacy of experimental group was superior to those of control group. There were no changes in Electrocardiogram, hepatic and renal functions, blood routine and urine routine between before and after testing. Manipulability, stability, and display and control system of lithotripsy were all well. Although there was one case being not good in the safety and total evaluation, there was no statistical difference compared with the control group. Conclusion： Electromagnetic extracorporeal shock wave lithotripsy （XYS.SUI-6X） is safe and efficient in treating upper urinary calculi, and can be used to treat upper urinary calculi in clinical practice, but it still needs to be improved.

关 键 词：体外冲击波碎石机 上尿路结石 试验研究 

分 类 号：R312[医药卫生—基础医学]