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双极与单极经尿道前列腺切除术治疗大前列腺或严重下尿路症状患者的安全性和有效性:一项欧洲多中心随机对照试验的事后分析

Safety and Efficacy of Bipolar Versus Monopolar Transurethral Resection of the Prostate in Patients with Large Prostates or Severe Lower Urinary Tract Symptoms: Post Hoc Analysis of a European Multicenter Randomized Controlled Trial.

作者信息

Skolarikos A, Rassweiler J, de la Rosette J J, Alivizatos G, Scoffone C, Scarpa R M, Schulze M, Mamoulakis C

机构信息

Second Department of Urology, Sismanoglio Hospital, University of Athens Medical School, Athens, Greece.

Department of Urology, SLK Kliniken Heilbronn, University of Heidelberg, Heilbronn, Germany.

出版信息

J Urol. 2016 Mar;195(3):677-84. doi: 10.1016/j.juro.2015.08.083. Epub 2015 Aug 28.

DOI:10.1016/j.juro.2015.08.083
PMID:26318982
Abstract

PURPOSE

We compare bipolar vs monopolar transurethral prostate resection safety/secondary outcomes including efficacy in patients with large prostate volume or severe lower urinary tract symptoms.

MATERIALS AND METHODS

From July 2006 to June 2009 candidates for transurethral prostate resection were recruited at 4 centers, randomized 1:1 into monopolar/bipolar transurethral prostate resection arms and followed up to 36 months. Post hoc data analysis from patients with large prostate volume or severe lower urinary tract symptoms is presented. Patients with large prostate volume or severe lower urinary tract symptoms were defined as those with transrectal ultrasound based prostate volume greater than 80 ml or International Prostate Symptom Score greater than 19. Safety was estimated using sodium/hemoglobin changes immediately after surgery, complications during the early postoperative period (up to 6 weeks), and short-term (up to 12 months) and midterm (up to 36 months) followup. Secondary outcomes included, among others, efficacy quantified by changes in maximum urine flow rate, post-void residual urine volume and International Prostate Symptom Score compared with baseline.

RESULTS

A total of 279 patients were randomized. Post hoc analysis of data from patients with a large prostate volume or severe lower urinary tract symptoms was based on analysis A-in 62 of 279 participants (22.3%) (monopolar transurethral prostate resection 32, bipolar transurethral prostate resection 30) or analysis B-in 126 of 279 participants (45.2%) (monopolar transurethral prostate resection 57, bipolar transurethral prostate resection 69). Mean (SD) prostate volume was 108.0 (25.9) ml for monopolar transurethral prostate resection and 108.9 (23.4) ml for bipolar transurethral prostate resection (p=0.756). Mean International Prostate Symptom Score was 25.0 (4.2) for monopolar transurethral prostate resection and 25.3 (3.7) for bipolar transurethral prostate resection (p=0.402). Neither safety nor any secondary outcome differed significantly between the arms throughout followup. The only exception was the decrease in sodium (analysis A), which was significantly greater after monopolar transurethral prostate resection (-4.2 vs -0.7 mmol/l, p=0.023) and did not translate into a significant difference in transurethral resection syndrome rates (monopolar transurethral prostate resection 1 of 32 vs bipolar transurethral prostate resection 0 of 30, p=1.000).

CONCLUSIONS

Bipolar and monopolar transurethral prostate resection show similar safety/efficacy in these patient subpopulations.

摘要

目的

我们比较双极与单极经尿道前列腺切除术的安全性及次要结局,包括对前列腺体积大或下尿路症状严重患者的疗效。

材料与方法

2006年7月至2009年6月,在4个中心招募经尿道前列腺切除术的候选患者,按1:1随机分为单极/双极经尿道前列腺切除术组,并随访36个月。本文呈现了对前列腺体积大或下尿路症状严重患者的事后数据分析。前列腺体积大或下尿路症状严重的患者定义为经直肠超声测定前列腺体积大于80 ml或国际前列腺症状评分大于19的患者。通过术后即刻钠/血红蛋白变化、术后早期(至6周)并发症以及短期(至12个月)和中期(至36个月)随访评估安全性。次要结局包括通过与基线相比最大尿流率、排尿后残余尿量及国际前列腺症状评分的变化来量化的疗效等。

结果

共279例患者被随机分组。对前列腺体积大或下尿路症状严重患者的数据进行事后分析,分析A纳入279例参与者中的62例(22.3%)(单极经尿道前列腺切除术32例,双极经尿道前列腺切除术30例),分析B纳入279例参与者中的126例(45.2%)(单极经尿道前列腺切除术57例,双极经尿道前列腺切除术69例)。单极经尿道前列腺切除术组的平均(标准差)前列腺体积为108.0(25.9)ml,双极经尿道前列腺切除术组为108.9(23.4)ml(p = 0.756)。单极经尿道前列腺切除术组的平均国际前列腺症状评分为25.0(4.2),双极经尿道前列腺切除术组为25.3(3.7)(p = 0.402)。在整个随访期间,两组在安全性及任何次要结局方面均无显著差异。唯一的例外是钠的降低(分析A),单极经尿道前列腺切除术后钠降低更显著(-4.2 vs -0.7 mmol/l, p = 0.023),但这并未转化为经尿道切除综合征发生率的显著差异(单极经尿道前列腺切除术32例中的1例 vs 双极经尿道前列腺切除术30例中的0例,p = 1.000)。

结论

在这些亚组患者中,双极与单极经尿道前列腺切除术的安全性/疗效相似。

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