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采用国产一次性电子输尿管软镜与可重复使用电子输尿管软镜治疗上尿路结石的前瞻性多中心随机对照研究

A prospective multicenter randomized controlled clinical trial study of a domestic single-use digital flexible ureteroscope versus a reusable digital flexible ureteroscope for the treatment of upper urinary tract stones

摘要:

目的:比较采用国产一次性电子输尿管软镜与可重复使用电子输尿管软镜治疗上尿路结石的安全性和有效性。方法:本研究采用前瞻性、单盲、多中心随机对照的试验方法,纳入2018年9月至2019年6月武汉大学人民医院、厦门大学附属第一医院、广州医科大学附属第一医院符合条件的患者,按照分层区组随机原则1∶1比例将患者分为试验组和对照组。纳入标准:①年龄18~75岁;②结石长径0.8~2.0cm且CT值<1 400Hu的单侧肾结石,或结石长径<1.5cm且CT值<1 400Hu的单侧输尿管上段结石;③术前尿细菌培养阴性;④肾功能正常。排除标准:①急性期泌尿系统感染;②合并输尿管瘢痕狭窄或输尿管狭窄、梗阻、扭曲等预计内镜不能通过;③合并全身出血性疾病或有出血倾向;④合并严重高血压、心肺功能不全无法耐受手术者;⑤严重髋关节畸形,取截石位困难者;⑥妊娠、哺乳期妇女。试验组采用国产(广州瑞派公司)一次性电子输尿管软镜,对照组采用进口(日本奥林巴斯公司)可重复使用电子输尿管软镜,行钬激光碎石术。记录两组临床综合评价(包括影像质量和操作性能)合格率、器械故障/缺陷率、碎石成功率、不良事件发生率(包括尿红细胞、白细胞计数升高,术后血尿、恶心、呕吐、头晕、发热等)。结果:本研究3家医院共纳入186例,其中8例因术中输尿管狭窄未能完成试验而退出研究,最终试验组90例,对照组88例。两组患者年龄[(48.40±11.36)岁与(47.40±12.53)岁, P=0.594]、男女比例(62/28与56/32, P=0.874)、体质指数[(24.8±2.1)kg/m 2与(25.1±2.0)kg/m 2, P=0.331]、中重度肾积水比例(28/90与23/88, P=0.874)、结石位置( P=0.063)、结石长径[(12.8±4.7)mm与(11.9±5.2)mm, P=0.227]差异均无统计学意义。试验组与对照组的临床综合评价合格率[98.9%(89/90)与100.0%(88/88), P=0.991]、碎石成功率[84.4%(76/90)与84.1%(74/88), P=0.888]差异均无统计学意义。试验组和对照组的器械故障/缺陷率均为0。试验组和对照组不良事件发生率分别为50.0%(45/90)和52.0%(51/88),差异无统计学意义( P=0.894)。两组不良事件发生率最高者均为术后尿常规红细胞升高[两组分别为88/90和88/88]和白细胞升高[分别为88/90和88/88];试验组未发生严重不良事件,对照组发生1例(1.1%)严重不良事件,为肾绞痛,两组差异无统计学意义( P=0.494)。 结论:采用国产一次性电子输尿管软镜治疗上尿路结石的器械故障/缺陷率、碎石成功率以及不良事件发生率与可重复使用电子输尿管软镜无明显差异。国产一次性电子输尿管软镜用于治疗上尿路结石具有良好的安全性和有效性。

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abstracts:

Objective:To compare the performance and surgical outcomes of domestic single-use digital flexible ureteroscopes with reusable digital flexible ureteroscopes in treatment of upper urinary stones.Methods:A prospective, single-blind, multicenter and randomized controlled study was performed from September 2018 to June 2019. Eligible patients were randomly assigned, in a ratio of 1∶1, to either experimental group or control group. The inclusion criteria for the study were: aged 18-75 years, solitary upper urinary stone with stone size between 0.8 and 2.0 cm and CT value less than 1 400 HU, negative preoperative urine culture and normal renal function. Exclusion criteria included: patients with acute urinary tract infection, intransitable urethral strictures, impassable ureteropelvic junction obstructions, systemic hemorrhagic disease, coagulation function abnormalities or bleeding tendency, severe hypertension or cardiopulmonary insufficiency, severe hip malformation and difficulty in meeting the demand of operation position and pregnant and lactation women. The device used in the experimental group was a domestic single-use digital flexible ureteroscope, and the device used in the control group was an imported Olympus digital flexible ureteroscope. The qualified rate of clinical comprehensive evaluation (including image quality and operational performance), the rate of device failure, the stone-free rate and the occurrence rate of adverse events (including increase in urine red blood cell and white blood cell counts, postoperative hematuria, nausea, vomiting, dizziness, and fever) in the two groups were recorded.Results:A total of 186 eligible study cases were collected from the People's Hospital of Wuhan University, the First Affiliated Hospital of Xiamen University, and the First Affiliated Hospital of Guangzhou Medical University. 90 cases in the final experimental group and 88 cases in the control group completed the trial and were included in the evaluation. There were no statistically significant differences among age [(48.40±11.36) vs. (47.40±12.53)years old, P=0.594], male to female ratio (62/28 vs. 56/32, P =0.874), BMI [(24.8±2.1) kg/m 2 vs. (25.1±2.0)kg/m 2,P =0.331], hydronephrosis (no/slight vs. mild/severe) (62/28 vs. 65/23, P =0.874), stone location and stone size [(12.8±4.7) mm vs. (11.9±5.2) mm, P =0.227]. There were no significant differences in terms of qualified rate of clinical comprehensive evaluation [98.9% (89/90) vs. 100.0% (88/88), P =0.991], lithotripsy success rate [84.4% (76/90) vs. 84.1% (74/88), P =0.888], device failure/defect rate (both 0%), and the incidence of adverse events [50.0% (45/90) vs. 52.0% (51/88), P =0.894]. The highest incidence of adverse events in two groups was the increase of red blood cells and white blood cells of routine urine after operation. There was no serious adverse event in the experimental group and 1 serious adverse event in the control group. Conclusions:There was no significant difference in image quality, device failure/defect rate, lithotripsy success rate, and adverse event rate between single-use digital flexible ureteroscopes and reusable digital flexible ureteroscopes for lithotripsy of upper ureteral and pelvic stones. Domestic single-use digital flexible ureteroscopes have good safety and effectiveness in the treatment and microscopy of upper urinary tract stones.

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