双波源与单波源体外碎石机治疗肾及输尿管上段结石疗效的前瞻性双中心随机对照研究

Dual shock wave lithotripter versus single shock wave mode for treatment of kidney and upper ureteral calculus:a double-center prospective randomized study

目的:探讨双波源体外碎石机治疗肾和输尿管上段结石的安全性、有效性及其与单波源碎石模式对比的优势。方法:本研究采用前瞻性、双中心、随机对照的方法,于2019年1月~2020年2月,按1∶1的比例将符合入组条件的肾和输尿管上段结石患者通过分层区组随机方法分为试验组和对照组。试验组采用双波源碎石模式,对照组采用单波源碎石模式。比较两组患者的碎石次数、碎石时间、曝光时间、碎石能级、术中疼痛情况、碎石成功率、部分粉碎率、无粉碎率及术后并发症情况,包括肾周血肿、血尿、感染发热、皮肤瘀伤等。结果:本研究共纳入600例患者,其中554例患者完成试验。试验组与对照组在性别、年龄、身高、体重、结石部位、结石最大径、合并肾积水程度、结石CT值及合并症等方面比较差异无统计学意义(P>0.05)。两组在碎石效能方面,碎石时间[(26.7±4.8)min vs.(36.9±6.5)min,P<0.05]、曝光时间[(3.9±0.8)min vs.(4.1±0.7)min,P>0.05]、碎石次数[(1372±179)次vs.(1814±236)次,P<0.05]、碎石能级[(10.2±2.1)kV vs.(13.4±3.0)kV,P<0.05]、碎石成功率为(83.1%vs.70.2%,P<0.05),上述两组结果的比较,除曝光时间外,其余各项差异均有统计学意义(P<0.05)。试验组患者的疼痛评分低于对照组[(5.3±0.9)vs.(7.2±0.7),P<0.05]。并发症方面,血尿、肾周血肿、感染发热、皮肤瘀伤的发生率试验组分别为[9例(3.3%)、2例(0.7%)、5例(1.8%)、11例(4.0%)]。对照组分别为28例(9.9%)、6例(2.1%)、4例(1.4%)、36例(12.8%),两组并发症的总体发生率比较差异有统计学意义[27例(9.9%)vs.75例(26.6%),P<0.05]。结论:双波源碎石机治疗肾和输尿管上段结石安全、有效,双波源碎石机较单波源碎石模式具备更高的碎石效率、更少的并发症。

Objective:To evaluate the clinical safety and efficacy of dual shock wave lithotripter in treating kidney or upper ureteral calculi,and compare its advantages to single shock wave mode.Method:A prospective,multicenter,randomized controlled study was performed from Jan.2019 to Feb.2020.Eligible patients were randomized in a ratio of 1∶1,to either experimental group or control group.Patients in experimental group received dual shock wave lithotripter,while patients in control group received single shock wave mode.Patients were followed by CT at 2 weeks after procedure.Comparative items included shock frequency,treating time,time of exposure,treating energy,pain scale,stone clearance rate and complication.Result:Six hundred patients were recruited,and 554 of them were finally completed the study(272 in experimental group,282 in control group).The demographic and preoperative parameters were comparable between the two groups(P>0.05).The dual shock wave subgroup achieved higher success rate(83.1%vs.70.2%,P<0.05)with less treating time[(26.7±4.8)min vs.(36.9±6.5)min,P<0.05],lower energy[(10.2±2.1)kV vs.(13.4±3.0)kV,P<0.05]and fewer shocks[(1372±179)times vs.(1814±236)times,P<0.05],lower complication rate[9.9%vs.26.6%,P<0.05],compared with those of the single shock wave subgroup.Also,pain scale was less than that of single shock wave subgroup[(5.3±0.9)vs.(7.2±0.7),P<0.05].Conclusion:Our study shows the dual shock wave lithotripter is safe and effective for both kidney and upper ureteral calculi.Dual mode has higher success rate and fewer complications.