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XprESS 多窦扩张系统治疗慢性鼻窦炎:NICE 医疗技术指导。

The XprESS Multi-Sinus Dilation System for the Treatment of Chronic Sinusitis: A NICE Medical Technology Guidance.

机构信息

York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, YO10 5NQ, UK.

Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Freeman Road, Newcastle upon Tyne, NE7 7DN, UK.

出版信息

Appl Health Econ Health Policy. 2017 Oct;15(5):567-582. doi: 10.1007/s40258-017-0337-7.

DOI:10.1007/s40258-017-0337-7
PMID:28669043
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5603631/
Abstract

The XprESS multi-sinus dilation system (XprESS) is a minimally invasive alternative to functional endoscopic sinus surgery (FESS) used in the treatment of people with chronic or recurrent acute sinusitis refractory to medical treatment. The manufacturer of XprESS, Entellus Medical, claims the technology is as effective as FESS in improving quality of life and is associated with quicker recovery times and reduced costs. The Medical Technologies Advisory Committee (MTAC) at the National Institute for Health and Care Excellence (NICE) selected XprESS for evaluation. Nine trials published in 13 papers were correctly identified by the company as relevant to the decision problem, including one randomised controlled trial (REMODEL study). From this evidence, the company concluded that XprESS is as beneficial as FESS for a range of clinical endpoints. The External Assessment Centre (EAC) agreed with the company's conclusion in a subgroup of patients, but judged that the evidence did not generalise to patients within the NHS fully. The company constructed a de novo costing model. XprESS generated cost-savings of £1302 per patient compared with FESS. The EAC critiqued and updated the model's inputs, with differences in results driven by changes in assumptions on procedure duration, length of hospital stay and the proportion of procedures undertaken in an outpatient setting under local anaesthetic. Although cost-incurring in the base case, XprESS generated cost savings under certain scenarios. The MTAC reviewed the evidence and supported the case for adoption, issuing positive draft recommendations. After public consultation NICE published this as Medical Technologies Guidance 30.

摘要

XprESS 多窦扩张系统(XprESS)是一种微创替代功能性内窥镜鼻窦手术(FESS),用于治疗对药物治疗无效的慢性或复发性急性鼻窦炎患者。XprESS 的制造商 Entellus Medical 声称,该技术在改善生活质量方面与 FESS 一样有效,并且与更快的恢复时间和降低成本相关。英国国家卫生与保健优化研究所(NICE)的医疗技术咨询委员会(MTAC)选择 XprESS 进行评估。该公司正确识别了 13 篇论文中发表的 9 项试验与决策问题相关,其中包括一项随机对照试验(REMODEL 研究)。根据这些证据,该公司得出结论,XprESS 在一系列临床终点方面与 FESS 一样有益。外部评估中心(EAC)在患者的亚组中同意公司的结论,但认为证据并没有完全推广到 NHS 内的患者。该公司构建了一个新的成本模型。与 FESS 相比,XprESS 每位患者可节省 1302 英镑的成本。EAC 对模型的投入进行了批评和更新,结果的差异是由于手术持续时间、住院时间以及在局部麻醉下进行的手术比例等假设的变化所致。尽管在基本情况下产生成本,但在某些情况下,XprESS 会产生成本节约。MTAC 审查了证据并支持采用该技术的理由,发布了积极的草案建议。在公众咨询后,NICE 将其作为医疗技术指南 30 发布。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94d4/5603631/37fd599aad33/40258_2017_337_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94d4/5603631/c38a39d8f5c8/40258_2017_337_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94d4/5603631/37fd599aad33/40258_2017_337_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94d4/5603631/c38a39d8f5c8/40258_2017_337_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94d4/5603631/37fd599aad33/40258_2017_337_Fig2_HTML.jpg

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本文引用的文献

1
REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies.采用更大队列进行长期预后研究,并对独立球囊扩张术研究进行荟萃分析。
Laryngoscope. 2016 Jan;126(1):44-50. doi: 10.1002/lary.25507. Epub 2015 Jul 30.
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The burden of revision sinonasal surgery in the UK-data from the Chronic Rhinosinusitis Epidemiology Study (CRES): a cross-sectional study.英国鼻窦手术翻修的负担——来自慢性鼻窦炎流行病学研究(CRES)的数据:一项横断面研究。
BMJ Open. 2015 Apr 29;5(4):e006680. doi: 10.1136/bmjopen-2014-006680.
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成人慢性鼻窦炎的成本:一项系统评价。
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Operative utilization of balloon versus traditional endoscopic sinus surgery.球囊与传统鼻内镜鼻窦手术的手术应用情况
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