CQS-01与EMS-Ⅲ超声气压弹道碎石清石系统的临床有效性和安全性对照试验研究  

Clinical safety and efficacy of a novel intracorporeal combined pneumatic and ultrasonic lithotriptor(CQS-01) compared with Swiss LithoClast Master(EMS-Ⅲ)

作　　者：熊六林[1] 黄晓波[1] 李建兴[1] 许清泉[1] 叶雄俊[1] 杨波[1] 马凯[1] 陈亮[1] 胡卫国[1] 王晓峰[1] 

机构地区：[1]北京大学人民医院泌尿外科,北京100034

出　　处：《北京大学学报（医学版）》2011年第4期548-555,共8页Journal of Peking University:Health Sciences

摘　　要：目的:评价CQS-01超声气压弹道碎石清石系统的有效性和安全性。方法:以CQS-01超声气压弹道碎石清石系统作为试验组,EMS-Ⅲ超声气压弹道碎石清石系统作为对照组,选取宜采用经皮肾镜碎石取石(percutaneous nephrolithotomy,PNL)治疗的肾结石或上段输尿管结石患者86例,随机分至试验组和对照组,每组各43例,观察时间为术后7±3天,主要疗效观察指标包括结石完全清除率、大部分清除率、手术时间、碎石清石时间、清石量,主要安全性指标包括血红细胞和血红蛋白变化、肾功能(BUN、Cr)变化、血清电解质变化、术后患者体温和血白细胞变化以及不良反应发生率等。结果:试验组和对照组术前在人口学、肾脏及结石特征方面差异均无统计学意义(P>0.05),术后两组的结石完全清除率分别为76.74%和79.07%(P=0.796),结石大部分清除率为23.26%和20.93%(P=0.796),手术时间分别为(92.49±76.59)min和(87.28±50.01)min(P=0.485),碎石清石时间分别为(50.16±57.11)min和(40.59±31.01)min(P=0.976),清石量分别为(10.85±20.08)mL和(5.05±6.00)mL(P=0.041)。试验组和对照组在术后24 h和术后7±3天,血红细胞和血红蛋白下降程度、下降例数、输血例数、BUN和Cr变化、电解质变化、术后炎症反应、不良反应发生率等方面均无明显差异(P>0.05)。结论:CQS-01超声气压弹道碎石清石系统在临床碎石清石效果、碎石清石能力和安全性等方面达到EMS-Ⅲ超声气压弹道碎石清石系统相似的水平。Objective： To evaluate the safety and efficacy of a new intracorporeal pneumatic and ultrasonic lithotriptor（CQS-01）.Methods： Eighty-six patients with renal or upper ureteral stones suitable for percutaneous nephrolithotomy（PNL） treatment were randomly divided into trial group（treated with CQS-01 device） and control group（treated with EMS-Ⅲ device）,with 43 patients in either group respectively.All the patients were followed up for 7±3 days post-operation.The data were collected and analyzed with regard to stone burden,postoperative stone clearance rate,operation time,stone fragmentation and extraction time,volume of extracted stones,changes of red blood cells（RBC） and hemoglobin（Hb）,occurrence rate of transfusion,changes of blood urea nitrogen（BUN） and creatinine（Cr）,serum electrolytes,white blood cells（WBC）,as well as body temperature and adverse events rate at 24 hours and 7±3 days post PNL operation.Results： No significant differences were found between the trial group and the control group（P〈0.05）,in terms of patients demography,renal characteristics and stone characteristics.In the trial group and the control group,respectively： the postoperative stone-free rate was 76.74% and 79.07%（P=0.796） and the partial stone clearance rate was 23.26% and 20.93%（P=0.796）,the operation time was（92.49±76.59） min and（87.28±50.01） min（P=0.485）,the stone fragmentation and extraction time was（50.16±57.11） min and（40.59±31.01） min（P=0.976）,the volume of extracted stones was（10.85±20.08） mL and（5.05±6.00） mL（P=0.041）.There were also no significant differences in postoperative RBC and Hb drops,occurrence rate of transfusion,postoperative BUN and Cr,body temperature changes,postoperative systemic inflammatory response and adverse events rate at 24 hours and 7±3 days post-operation between the trial and control groups（P〈0.05）.Conclusion： There is no significant difference in clinical safety,efficacy,and the stone cleara

关 键 词：肾结石 输尿管结石 碎石术 治疗结果 

分 类 号：R692.4[医药卫生—泌尿科学]