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钬激光与双极等离子电切治疗非肌层浸润性膀胱癌的多中心前瞻性随机对照研究

A prospective randomized controlled multicenter clinical study comparing HOLTUR and TURis in patients with non-muscle invasive bladder cancer

摘要:

目的 比较两种不同方法的经尿道膀胱肿瘤切除术(TURBT)治疗非肌层浸润性膀胱尿路上皮癌的疗效和安全性.方法 2010年4月至2014年12月收治的120例非肌层浸润性膀胱尿路上皮癌患者,男111例,女9例.年龄36 ~ 75岁.术前均行膀胱镜检查,肿瘤直径均<3 cm.采用计算机抽样生成两组随机号,将患者分为经尿道钬激光切除(holmium laser transurethral resection,HOLTUR)组和经尿道双极等离子电切(bipolar transurethral resection in saline,TURis)组,每组各60例.HOLTUR组男56例,女4例;肿瘤单发45例,多发15例;肿瘤位于左右侧壁40例(66.7%),顶壁5例(8.3%),后壁8例(13.3%),三角区4例(6.7%),颈部3例(5.0%).TURis组男55例,女5例;肿瘤单发42例,多发18例;肿瘤位于左右侧壁38例(63.3%),顶壁3例(5.0%),后壁10例(16.7%),三角区4例(6.7%),颈部5例(8.3%).两组资料比较差异均无统计学意义(P>0.05).HOLTUR组采用F21膀胱镜,进镜后观察肿瘤大小和位置,调节钬激光功率约为16 Hz/1 J.钬激光距肿瘤边缘1 cm处楔形切除膀胱肿瘤及其基底部膀胱壁组织直至深肌层.创面用钬激光确切止血后结束手术,较小肿瘤行活检后采用钬激光烧灼创面.TURis组采用F26双极等离子电切镜,进镜后观察肿瘤大小和位置,自肿瘤表面起分块切除肿瘤组织直至深肌层.创面用TURis确切止血后结束手术.比较两组的手术时间、闭孔神经反射发生率、膀胱穿孔发生率、导尿管保留时间、术后住院时间及术后3个月复发率等.结果 两组手术均顺利完成,无中转开放术式.HOLTUR组和TURis组的手术时间分别为(22.6±2.4) min和(33.3±13.8)min;闭孔神经反射发生例数分别为0和26例(43.3%);膀胱穿孔发生例数分别为0和6例(10.0%),两组间比较差异均有统计学意义(P<0.05).术后病理分级,HOLTUR组低级别54例,高级别6例,其中伴原位癌1例;TURis组低级别53例,高级别7例,其中伴原位癌2例,两组比较差异无统计学意义(P>0.05).肿瘤危险度分级,HOLTUR组低危21例,中危31例,高危8例;TURis组低危23例,中危28例,高危9例,两组间比较差异无统计学意义(P>0.05).HOLTUR组和TURis组的留置尿管时间[(1.7 ±0.2)d vs.(1.6±0.2)d]、术后住院时间[(3.4±0.3)d vs.(3.9±0.2)d]和术后3个月复发例数[5例vs.7例]比较差异均无统计学意义(P>0.05).结论 与TURis相比,采用HOLTUR治疗非肌层浸润性膀胱尿路上皮癌具有手术时间短、无闭孔神经反射、并发症少等优势,疗效可靠,手术更安全.

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abstracts:

Objective Compare the efficacy and safety of transurethral holmium laser resection of non-muscle invasive bladder tumor (HOLTUR) with transurethral resection in saline (TURis) method.Method From April 2010 to December 2014,in urology department of three different comprehensive medical center 120 cases of non-muscle invasive bladder cancer patients (111 male,9 female) were admitted;aged from 36 to 75 years old.The patients were randomized divided into two groups:holmium laser resection(HOLTUR) group (60 cases) and bipolar transurethral resection in saline (TURis) group (60 cases).HOLTUR group included 56 male and 4 female patients.In HOLTUR group 45 patients had single tumor in bladder,15 patients had multiple tumors (2-4) in bladder;Tumor location:left and right wall 40cases(66.7%),anterior wall 5 cases(8.3%),posterior wall 8 cases(13.3%),trigone 4 cases(6.7%),bladder neck 3 cases (5.0%).TURis group included 55 male and 5 female patients.In TURis group 42 patients had single tumor in bladder,18 patients had multiple tumors (2-4) in bladder (P =0.888).Tumor location:left and right wall 38 cases (63.3%),anterior wall 3 cases (5.0%),posterior wall 10 cases (16.7%),trigone 4 cases (6.7%),Neck 5 cases (8.3%).There is no statistical difference between 2 groups(P > 0.05).The surgery method:①HOLTUR change the holmium laser rate to 16Hz,energy to 1 J.The bladder was examined with Olympus cystoscopy to confirm the tumor size and location.The holmium laser was used to resect the tumor 1 cm far from the tumor edge and its base to the bladder deep muscle.We also used holmium laser for hemostasis.For little bladder tumor we used holmium laser to vaporize the tumor directly after biopsy.②TURis:We use the olympus bipolar resectoscope to examine the bladder and confirm the location and size of tumor.Then we resected the tumor piece by piece until the deep muscle of bladder.And we used the TURis for hemostasis.The perioperative data of two groups were collected and compared.Perioperative data included the operation time,the obturator reflex incidence,bladder perforation incidence,catheterization time,postoperative hospital stay,tumor recurrence rate 3 months after surgery.Results All of the surgery were successful done.There were statistical difference (P < 0.05 =between the operation time of two groups (22.6 ± 2.4) mins (HOLTUR group) vs.(33.3 ± 13.8) mins (TURis group),the obturator reflex incidence 0 (HOLTUR group) vs.43.3% (TURis group),the perforation rate of bladder 0 (HOLTUR group) vs.10.0% (TURis group).In HOLTUR group 54 patients had low grade bladder tumor,6 patients had high grade tumor,among whom one patient had carcinoma in situ(CIS).In TURis group 53 patients had low grade bladder tumor,7 patients had high grade tumor,among whom 2 patients had CIS.There was no statistical difference between two groups(P =1.000).According to 2014 CUA Guideline of non-muscle invasive bladder tumor,in HOLTUR group there were 21 patients with low risk,31 patients with middle risk and 8 high risk patients.In TURis group there were 23 patients with low risk,28 patients with middle risk and 9 patients with high risk.There were no statistical difference in tumor stage between two groups (P =1.000).There were no significant difference (P > 0.05) of urinary catheter retention time (1.7 ± 0.2) days vs.(1.6 ± 0.2) days,(P =0.666),postoperative hospital stay (3.4 ± 0.3) days vs.(3.9 ± 0.2) days,(P =0.150)and recurrence rate 3 months after surgery(5/60 vs.7/60,P =0.762) between HOLTUR and TURis group.Conclusions Compared with TURis,transurethral holmium laser resection of non-muscle invasive bladder cancer has shorter operation time,no obturator nerve reflex,and less complications.It is a safe and reliable methods for the bladder tumor.

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