新型输尿管球囊扩张导管治疗良性输尿管狭窄的前瞻性随机对照研究

Application of a new-type ureteroscopic balloon dilation catheter in the treatment of benign ureteral stricture:aprospective randomized controlled trial

目的:探讨一种泌尿外科内镜腔道内输尿管球囊扩张导管在良性输尿管狭窄治疗中的应用价值,并评估其疗效及安全性。方法:良性输尿管狭窄患者40例,按1∶1随机分为两组,一组为试验组(20例),应用一种泌尿外科内镜腔道内输尿管球囊扩张导管进行输尿管狭窄球囊扩张手术;另一组为对照组(20例),应用Bard U30输尿管球囊扩张导管进行手术。收集两组术前、术中及术后临床资料。结果:两组间性别、年龄、输尿管狭窄部位、长度、术前肾积水程度、术前患侧肾肾小球滤过率(GFR)比较差异均无统计学意义。试验组平均手术时间显著短于对照组,差异有统计学意义[(24.2±2.4)min vs.(30.8±5.8)min,P<0.05]。试验组有效率为70%(14/20),对照组75%(15/20),两组比较差异无统计学意义(P>0.05)。两组间术后并发症、平均住院天数比较差异均无统计学意义(P>0.05)。结论:输尿管球囊扩张是治疗良性输尿管狭窄安全、有效的方法,与传统Bard U30球囊扩张导管相比,泌尿外科内镜腔道内输尿管球囊扩张导管可通过输尿管硬镜操作通道直接直视下操作,减少放射性损害,显著缩短手术时间,降低手术操作难度,近期疗效确切,是一种安全、高效的输尿管狭窄微创治疗手段。

Objective:To explore the value of a urological endoscopic transluminal ureteroscopic balloon dilation catheter in the treatment of benign ureteral stricture and evaluate its efficacy and safety.Method:A total of 40 patients with benign ureteral stricture were randomly divided into two groups as a ratio of 1∶1.The experimental group consisted of 20 patients who underwent balloon dilation with an Innovex urological endoscopic transluminal ureteroscopic balloon dilation catheter.In the control group,the Bard U30 ureteroscopic balloon dilation catheter was used.The pre-operative,operative and post-operative data were collected.Result:There was no statistical difference between the two groups in sex,age,location,length of ureteral stricture,degree of pre-operative hydronephrosis and pre-operative ipsilateral glomerular filtration rate.Compared to the control group,the experimental group experienced significantly less operative time[(24.2±2.4)min vs.(30.8±5.8)min,P<0.05].The success rate of the experimental group was 70% which was comparable to the control group(75%).No significant difference was found with respect to the complications or hospital stay between the two groups.Conclusion:The ureteroscopic balloon dilation is safe and effective for treatment of benign ureteral stricture.Compared to traditional Bard U30 ureteroscopic balloon dilation catheter,the newly designed urological endoscopic transluminal ureteroscopic balloon dilation catheter can be manipulated under direct vision through the ureteroscopic operation channel with less radiation exposure,shorter operative time,less operative difficulty and definite short-term therapeutic effect.