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男性下尿路症状的新兴微创治疗选择。

Emerging Minimally Invasive Treatment Options for Male Lower Urinary Tract Symptoms.

机构信息

Department of Urology, Ludwig-Maximilians-University of Munich, Munich, Germany.

Department of Urology Research, University of Sheffield, Sheffield, England, UK.

出版信息

Eur Urol. 2017 Dec;72(6):986-997. doi: 10.1016/j.eururo.2017.07.005. Epub 2017 Jul 19.

Abstract

CONTEXT

Lower urinary tract symptoms (LUTS) are one of the most common and troublesome nonmalignant conditions affecting quality of life in aging men. A spectrum of established medical and surgical options is available to provide relief of bothersome LUTS. Both the adverse events of medication and the morbidity with surgical treatment modalities have to be counterbalanced against efficacy. Novel minimally invasive treatment options aim to be effective, ideally to be performed in an ambulatory setting under local anaesthesia and to offer a more favourable safety profile than existing reference techniques.

OBJECTIVE

A comprehensive, narrative review of novel minimally invasive treatment modalities for the management of male LUTS due to benign prostatic enlargement is presented.

EVIDENCE ACQUISITION

Medline, PubMed, Cochrane database, and Embase were screened for randomised controlled trials (RCTs), clinical trials, and reviews on novel minimally invasive treatment options for male LUTS due to benign prostatic enlargement.

EVIDENCE SYNTHESIS

With regard to newly devised intraprostatic injectables (botulinum neurotoxin A, NX1207, PRX302), PRX302 is currently the only substance that was superior to placebo in a phase 3 RCT providing proof of efficacy and safety. The prostatic urethral lift technique has been evaluated in several phase 3 trials showing rapid and durable relief of LUTS without compromising sexual function in carefully selected patients without a prominent median lobe. The first clinical experience of the temporary implantable nitinol device demonstrated that implantation of this novel device is a safe procedure, easy, and fast to perform. Further studies are required to evaluate efficacy, durability, and to define appropriate patient selection. New ablative approaches like the image guided robotic waterjet ablation (AquaBeam) or procedures based on convective water vapour energy (Rezūm) are in the early stages of development. Prostatic artery embolization performed by interventional radiologists at specialised centres shows a high technical success rate in the treatment of bothersome LUTS. However, a substantial clinical failure rate and a particular spectrum of complications not commonly seen after urologic interventions do occur and need to be critically evaluated.

CONCLUSIONS

Initial promising clinical results on novel minimally invasive treatment options indicate efficacy comparable to standard techniques, often associated with a more favourable safety profile, in particular with preservation of sexual function. Many of these techniques are in their infancy and based on experience of new developments in the past. Further RCTs are required to evaluate efficacy, safety, and durability of novel techniques with long-term follow-up and careful evaluation of the selection criteria, which have been applied in clinical trials. The prostatic urethral lift is the only procedure with Level 1 evidence data and that can therefore be recommended for treatment of male LUTS in clinical practice for selected patients.

PATIENT SUMMARY

Minimally invasive treatment options have been developed to provide relief of lower urinary tract symptoms comparable to standard surgical techniques with a more favourable safety profile. However, long-term clinical evaluation is still needed for most of these innovations before they can be recommended to be an effective replacement for standard surgical treatment.

摘要

背景

下尿路症状(LUTS)是影响老年男性生活质量的最常见和最麻烦的非恶性疾病之一。有一系列成熟的医学和外科选择方案可用于缓解烦人的 LUTS。药物的不良反应和手术治疗方式的发病率必须与疗效相平衡。新型微创治疗方案旨在有效,理想情况下在局部麻醉下在门诊环境中进行,并且比现有参考技术具有更有利的安全性。

目的

本文对新型微创治疗男性良性前列腺增生引起的 LUTS 的管理进行了全面的叙述性综述。

证据获取

对 Medline、PubMed、Cochrane 数据库和 Embase 进行了筛选,以获取有关新型微创治疗男性良性前列腺增生引起的 LUTS 的随机对照试验(RCT)、临床试验和综述。

证据综合

关于新设计的前列腺内注射剂(肉毒杆菌神经毒素 A、NX1207、PRX302),PRX302 是目前唯一一种在 3 期 RCT 中优于安慰剂的物质,证明了疗效和安全性。前列腺尿道提升技术已在几项 3 期试验中进行了评估,结果表明,在没有突出的中叶的情况下,该技术可以在精心挑选的患者中快速而持久地缓解 LUTS,同时不影响性功能。新型可植入镍钛诺装置的首次临床经验表明,植入这种新型装置是一种安全的手术,易于操作且快速。需要进一步的研究来评估疗效、耐久性和合适的患者选择。新的消融方法,如图像引导机器人水射流消融(AquaBeam)或基于对流水蒸汽能量的方法(Rezūm)处于早期开发阶段。介入放射学家在专门中心进行的前列腺动脉栓塞术在治疗烦人的 LUTS 方面显示出高的技术成功率。然而,会出现相当大的临床失败率和一些通常在泌尿科手术后不常见的特定并发症,需要进行批判性评估。

结论

新型微创治疗方案的初步有希望的临床结果表明,其疗效可与标准技术相媲美,通常与更有利的安全性相关,特别是在保留性功能方面。这些技术中的许多仍处于起步阶段,并且基于过去在新发展方面的经验。需要进一步的 RCT 来评估具有长期随访和仔细评估临床试验中应用的选择标准的新型技术的疗效、安全性和耐久性。前列腺尿道提升术是唯一具有 1 级证据数据的手术,因此可以推荐用于临床实践中为选定患者治疗男性 LUTS。

患者总结

已经开发了微创治疗方案,以提供与标准手术技术相当的下尿路症状缓解,且具有更有利的安全性。然而,在这些创新被推荐为标准手术治疗的有效替代方法之前,大多数治疗方案仍需要进行长期的临床评估。

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