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許齡內 復發性球囊尿道狹窄的外科治療:開放性尿道成形術與內鏡下尿道切開術的隨機開放標籤優勢試驗 (the OPEN Trial) 2021/9/1 下午 04:12:13
原 文 題  目 Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial)
作  者 Beatriz Goulao, Sonya Carnell, Jing Shen, Graeme MacLennan, John Norrie, Jonathan Cook, Elaine McColl, Matt Breckons, Luke Vale, Paul Whybrow, Tim Rapley, Rebecca Forbes, Stephanie Currer, Mark Forrest, Jennifer Wilkinson, Daniela Andrich, Stewart Barclay, Anthony Mundy, James N’Dowk, Stephen Payne, Nick Watkin, Robert Pickard
出  處 Eur Urol. 2020 Oct;78(4):572-580.
出版日期 2020 Oct
評 論

美國研究機構估計尿道狹窄發生在成年男性最多可達0.9%。環形尿道疤痕,通常發生在球囊尿道,因而導致排尿困難與增加尿滯留的機率。治療首次發生的尿道狹窄時,通常是以微創技術治療,經尿道下以膀胱鏡佐以切割鋼刀片在小區域中切開狹窄的環形尿道疤痕組織,即所謂經尿道內視鏡下尿道切開術,或採用刻度尿道擴張器將環形尿道疤痕撐開。然而近一半的男性尿道狹窄患者4年內又會面臨尿道狹窄再次復發,因而需要進一步介入治療與手術,例如:通過經尿道內視鏡手術或以更具侵入性的方式完成重建尿道狹窄區域,如開放性尿道成形術。根據醫療機構統計顯示反覆經尿道內視鏡下尿道切開術是最常用以治療復發性球囊尿道狹窄的手術治療方法,但根據系統研究與臨床指南之建議,以開放性尿道成形術治療復發性球囊尿道狹窄才是較為適當之作法。

在此次開放標籤-雙臂-隨機對照試驗中,招募了於英國國家健康服務醫院就醫的男性尿道狹窄患者,並隨機分配了222名男性接受開放性尿道成形術或經尿道內視鏡下尿道切開術。試驗分析發現包括69(63%)位受試患者接受開放性尿道成形術,90(81%)位受試患者接受經尿道內視鏡下尿道切開術,開放性尿道成形術和經尿道內視鏡下尿道切開術兩者之間的平均差為–0.36(95%信賴區間[CI]–1.74至1.02)。其中15位接受開放性尿道成形術的受試患者相對於29位接受經尿道內視鏡下尿道切開術的受試患者,其需要接受再次介入性手術的機率相對較低 (危險比 [95%CI] 0.52 [0.31-0.89])。

雖然以開放性尿道成形術治療球狀尿道狹窄後,其尿道狹窄復發時間間隔較長為其優點,但球囊尿道狹窄的治療程序,是以改善以下尿路症狀與排尿狀況為基礎並且不會造成患者重大傷害為主,因此開放性尿道成形術或經尿道內視鏡下尿道切開術都可以使用。因此,臨床醫師需考量患者之狀況、手術之專業能力與醫療院所具備之設備等因素,給予患者適當的治療,才是對患者最好的治療。

abstract

Background: Urethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within 4 yr. Options for further treatment are repeat urethrotomy or open urethroplasty. Objective: To compare the effectiveness and cost effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture. Design, setting, and participants: This was an open label, two-arm, patient-randomised controlled trial. UK National Health Service hospitals were recruited and 222 men were randomised to receive urethroplasty or urethrotomy. Intervention: Urethrotomy is a minimally invasive technique whereby the narrowed area is progressively widened by cutting the scar tissue with a steel blade mounted on a urethroscope. Urethroplasty is a more invasive surgery to reconstruct the narrowed area. Outcome measurements and statistical analysis: The primary outcome was the profile over 24 months of a patient-reported outcome measure, the voiding symptom score. The main clinical outcome was time until reintervention. Results and limitations: The primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy, respectively. The mean difference between the urethroplasty and urethrotomy groups was –0.36 (95% confidence interval [CI] –1.74 to 1.02). Fifteen men allocated to urethroplasty needed a reintervention compared with 29 allocated to urethrotomy (hazard ratio [95% CI] 0.52 [0.31–0.89]). Conclusions: In men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty. Patient summary: There was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions.

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