目的 探讨采用国产组合式输尿管软镜(少刚镜®)治疗肾及输尿管上段结石的临床效果和优势。方法 2014年1月~2016年10月收治664例肾结石患者,分别进行进口一体式输尿管软镜和国产组合式输尿管软镜(少刚镜®)联合钬激光治疗。进口一体式软镜碎石治疗患者136例,其中男101例,女35例,年龄19~68岁,平均42.3岁。结石位于肾上盏15例,中盏29例,下盏40例,肾盂52例。结石直径(2.3±0.5)cm。行国产组合式输尿管软镜(少刚镜®)碎石528例,其中男377例,女151例。年龄26~72岁,平均36.6岁。结石位于肾上盏72例,中盏63例,下盏162例,肾盂231例。结石平均直径(2.4±0.5)cm。比较两种输尿管软镜碎石的临床效果及安全性,以及两种输尿管软镜的使用成本。结果 两组患者一般情况差异无统计学意义。 进口一体式输尿管软镜碎石组,术中寻及结石134例,结石寻及率98.5% (134/136)。2例患者因盏颈细长过深和IP角度过小而未能找到结石,并改变手术方式。手术时间31~82 min,平均51.7 min。术后发热6例,抗感染治疗后好转。无输血、感染性休克、输尿管穿孔或撕脱等严重并发症。术后住院时间2~3 d,平均2.1 d。4周后行腹部平片(KUB)检查并拔除双J管,124例结石已排净,5例进行二次输尿管软镜碎石后排净,一期结石清除率(SFR)92.6%(124/134),二期结石清除率96.3%(129/134),5例肾下盏结石残余(小于4 mm),无需行外科干预。手术时间27~75 min,平均47.5 min。国产组合式输尿管软镜(少刚镜®)组术中寻及结石513例,结石寻及率97.2%(513/528)。术后发热13例,严重出血、感染性休克、肾输尿管穿孔或撕脱等严重并发症。术后住院时间2~3 d,平均2.3 d。4~6周后行KUB检查并拔除双J管,477例结石已排净,20例进行二次输尿管软镜碎石后排净,SFR为93.0%(477/513),二期结石清除率96.9%(497/513),16例肾下盏结石残余(大小为 3~4 mm)。与一体式输尿管软镜比较,手术时间、术后住院时间、结石寻及率和无石率、术后并发症发生率均无明显差异。但是,组合式输尿管软镜购置和使用成本更低。结论 国产组合式输尿管软镜(少刚镜®)治疗肾结石具有质轻易于操控、疗效确切、手术安全、耗材成本较低等优点,值得临床推广。

Objective: To evaluate the clinical efficacy and advantages of domestic assembled flexible ureteroscope (Shao Gang ureteroscope®, Youcare Tech.) for management of renal stones.Methods: From March 2013 to October 2016 in our department, 664 patients with renal stones were divided in two groups randomly and treated with imported integrated flexible ureteroscope (IIFU) or domestic assembled flexible ureteroscope (Shao Gang ureteroscope®) (DAFU) respectively. IIFU group had 136 cases including 101 males and 35 females, aged 19-68 years (mean 42.3). Calculi were in the upper renal calyx in 15 cases, middle renal calyx in 29 cases, lower renal calyx in 40 cases, and renal pelvis in 52 cases. The diameter of kidney stones was 2.3±0.5 cm. DAFU group had 528 cases including 377 males and 151 females, aged 26-72 years old (mean 36.6 years). Calculi were in the upper renal calyx in 72 cases, middle renal calyx in 63 cases, lower renal calyx in 162 cases, and renal pelvis in 231 cases. The diameter of kidney stones was 2.4±0.5 cm. The general information of two groups had no statistically significant difference.Results: In IIFU group, the operation time was 31-82 min (average 51.7 min). The calculi in 134 cases were found during operation and stone-find rate was 98.5% (134/136). 124 cases obtained stone-free status with one session, and 5 cases obtained stone-free status after two sessions. Single session stone-free rate (SFR) was 92.6% (124/134), and overall stone-free rate was 96.3% (129/134). The residual fragments (diameter less than 4 mm) were observed in 5 cases, which were all located in lower calyxes and did not need for further treatment. Six cases had postoperative fever. No severe perioperative complications such as blood transfusion, septic shock, ureteral perforation or avulsion occurred. The patients were discharged from hospital in 2-3 days (average 2.1 days) postoperatively. In DAFU group, the operation time was 27-75 min (average 47.5 min). The calculi in 513 cases were found during operation and stone-find rate was 97.2% (513/528). 477 cases obtained stone-free status with one session, and 20 case obtained stone-free status after two sessions. SFR was 93.0% (477/513), and overall stone-free rate was 96.9% (497/513). The residual fragments (diameter less than 4 mm) were observed in 16 cases, which were all located in lower calyxes and did not need for further treatment. There was no statistically signifcant difference between two groups in operation time, stone-find rate, SFR, complications and postoperative hospital stay. However, the cost of purchase and maintenance of domestic assembled flexible ureteroscope was cheaper than imported integrated flexible ureteroscope.Conclusions: Domestic assembled flexible ureteroscope (ShaoGang ureteroscope®) in renal stone treatment had a definite effect. Not only the cost of the materials was low, but also the operation had advantages in more convenient, safe and comfortable for doctors.