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用于治疗良性前列腺增生继发下尿路症状的Urolift系统:英国国家卫生与临床优化研究所医疗技术指南

The Urolift System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance.

作者信息

Ray Alistair, Morgan Helen, Wilkes Antony, Carter Kimberley, Carolan-Rees Grace

机构信息

Cardiff University, Cardiff, Wales, UK.

Cardiff and Vale University Health Board, Cardiff, Wales, UK.

出版信息

Appl Health Econ Health Policy. 2016 Oct;14(5):515-26. doi: 10.1007/s40258-015-0218-x.

DOI:10.1007/s40258-015-0218-x
PMID:26832146
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5025508/
Abstract

As part of its Medical Technologies Evaluation Programme (MTEP), the National Institute for Health and Care Excellence (NICE) invited Neotract (manufacturer) to submit clinical and economic evidence for their prostatic urethral lift device, Urolift, for the relief of lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS BPH). The Urolift System uses implants to retract the prostatic lobe away from the urethral lumen. The clinical evidence used in the manufacturer's submission shows that Urolift is effective for the treatment of BPH. Urolift delivers a weighted mean International Prostate Symptom Score (IPSS) improvement of between 9.22 and 11.82 points. These Urolift improvements are greater than a published 'marked improvement' in IPSS score of 8.80. Comparison with randomised controlled trials (RCTs) of TURP (Transurethral Resection of Prostate) and HoLEP (Holmium Laser Enucleation of Prostate) show that Urolift does not yield better clinical outcomes from baseline compared to TURP and HoLEP in terms of IPSS, QoL (Quality of Life) and Qmax (maximum urinary flow). However, Urolift appears to have the advantage in terms of minimal and mild complications, and this may be of interest to patients and urologists. The economic case for Urolift was made using a very detailed and thorough de novo cost model. The base case posed by the manufacturer placed Urolift at almost cost-neutral (£3 cost incurring, based on 2014 prices) compared to TURP, and £418 cost incurring compared to HoLEP. In an additional scenario comparing day-case Urolift with in-patient TURP, the estimated per-patient savings with Urolift were £286 compared with monopolar TURP (mTURP) and £159 compared with bipolar TURP (BiTURP). NICE guidance MTG26 recommends that the case for adoption of Urolift was supported by the evidence, when implemented in a day-case setting.

摘要

作为其医疗技术评估计划(MTEP)的一部分,英国国家卫生与临床优化研究所(NICE)邀请Neotract(制造商)提交其前列腺尿道提升装置Urolift用于缓解良性前列腺增生继发下尿路症状(LUTS BPH)的临床和经济证据。Urolift系统使用植入物将前列腺叶从尿道腔缩回。制造商提交的临床证据表明,Urolift对治疗BPH有效。Urolift使国际前列腺症状评分(IPSS)加权平均值改善了9.22至11.82分。这些Urolift的改善大于已公布的IPSS评分“显著改善”值8.80。与经尿道前列腺切除术(TURP)和钬激光前列腺剜除术(HoLEP)的随机对照试验(RCT)比较表明,就IPSS、生活质量(QoL)和最大尿流率(Qmax)而言,与TURP和HoLEP相比,Urolift从基线开始并未产生更好的临床结果。然而,Urolift在轻微和轻度并发症方面似乎具有优势,这可能对患者和泌尿外科医生有吸引力。Urolift的经济情况是使用非常详细和全面的全新成本模型得出的。制造商提出的基础案例表明,与TURP相比,Urolift几乎成本持平(基于2014年价格,成本为3英镑),与HoLEP相比成本为418英镑。在另一个将日间手术Urolift与住院TURP进行比较的情景中,与单极TURP(mTURP)相比,Urolift估计每位患者节省286英镑,与双极TURP(BiTURP)相比节省159英镑。NICE指南MTG26建议,当在日间手术环境中实施时,采用Urolift的案例有证据支持。

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