新型体内联合气动和超声碎石机（CQS-01）与瑞士LithoClast Master（EMS-III）相比的临床安全性和有效性

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

作者信息

Xiong Liu-lin, Huang Xiao-bo, Li Jian-xing, Xu Qing-quan, Ye Xiong-jun, Yang Bo, Ma Kai, Chen Liang, Hu Wei-guo, Wang Xiao-feng

机构信息

Department of Urology, Peking University People's Hospital, Beijing 100034, China.

出版信息

Beijing Da Xue Xue Bao Yi Xue Ban. 2011 Aug 18;43(4):548-55.

PMID:21844964

Abstract

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, post-operative 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 clearance capability between CQS-01 device and EMS-III device.

摘要

目的

评估一种新型体内气动超声碎石机（CQS - 01）的安全性和有效性。

方法

将86例适合经皮肾镜取石术（PNL）治疗的肾或输尿管上段结石患者随机分为试验组（采用CQS - 01设备治疗）和对照组（采用EMS - III设备治疗），每组各43例。所有患者术后随访7±3天。收集并分析有关结石负荷、术后结石清除率、手术时间、结石破碎及取出时间、取出结石体积、红细胞（RBC）和血红蛋白（Hb）变化、输血发生率、血尿素氮（BUN）和肌酐（Cr）变化、血清电解质、白细胞（WBC）以及PNL术后24小时和7±3天的体温和不良事件发生率的数据。

结果

试验组和对照组在患者人口统计学、肾脏特征和结石特征方面无显著差异（P>0.05）。试验组和对照组分别：术后结石清除率为76.74%和79.07%（P = 0.796），部分结石清除率为23.26%和20.93%（P = 0.796），手术时间为（92.49±76.59）分钟和（87.28±50.01）分钟（P = 0.485），结石破碎及取出时间为（50.16±57.11）分钟和（40.59±31.01）分钟（P = 0.976），取出结石体积为（10.85±20.08）毫升和（5.05±6.00）毫升（P = 0.041）。试验组和对照组在术后RBC和Hb下降、输血发生率、术后BUN和Cr、体温变化、术后全身炎症反应以及术后24小时和7±3天的不良事件发生率方面也无显著差异（P>0.05）。