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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 effectiveness and safety of CQS-01 ultrasonic pneumatic lithotripsy clear stone system. Methods: CQS-01 ultrasound pneumatic lithotripsy clear stone system as the test group, EMS-Ⅲ ultrasonic pneumatic lithotripsy clear stone system as the control group, the selection should be treated with percutaneous nephrolithotomy (percutaneous nephrolithotomy, PNL) Of the 86 cases of renal calculi or upper ureteral calculi, were randomly divided into experimental group and control group, 43 cases in each group, the observation time was 7 ± 3 days after operation. The main efficacy indicators included complete stone clearance, most of the clearance , Operation time, gravel stone time, stone volume, the main safety indicators including changes in red blood cells and hemoglobin, changes in renal function (BUN, Cr), serum electrolytes, postoperative patients with body temperature and leukocyte changes and adverse reactions Rate and so on. Results: There was no significant difference in demography, kidney and stone characteristics before and after operation between the two groups (P> 0.05). The complete clearance rate of the two groups was 76.74% and 79.07% (P = 0.796 ), The stone removal rate was 23.26% and 20.93% respectively (P = 0.796), the operation time was (92.49 ± 76.59) min and (87.28 ± 50.01) min 50.16 ± 57.11) min and (40.59 ± 31.01) min respectively (P = 0.976). The amount of fossil stone was (10.85 ± 20.08) mL and (5.05 ± 6.00) mL respectively. The levels of erythrocyte and hemoglobin, the number of blood transfusion, the number of blood transfusion, the changes of BUN and Cr, the changes of electrolytes, the postoperative inflammatory reaction and the incidence of adverse reactions in the experimental group and the control group at 24 h and 7 ± 3 d after operation No significant difference (P> 0.05). CONCLUSION: The CQS-01 ultrasonic pneumatic lithotripsy clear stone system achieves the similar level of EMS-Ⅲ ultrasonic pneumatic lithotripsy clear stone system in the aspects of clinical lithotripsy effect, lithotripsy ability and safety.