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首页> 外文期刊>Journal of bronchology & interventional pulmonology >The Coming of Age of Endoscopic Lung Volume Reduction
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The Coming of Age of Endoscopic Lung Volume Reduction

机译:内镜肺体积减少的年龄

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On June 29, 2018, the Food and Drug Administration (FDA) from United States approved the Zephyr valve for the treatment of breathing difficulty associated with severe emphysema (www.accessdata.fda.gov/cdrh_docs/ pdfl8/P 180002a.pdf). It happened almost 15 years after the first publication of a case series suggesting that lung volume reduction can be achieved with bronchoscopically placed valve implants in patients with severe emphysema, with acceptable short-term safety and worthwhile functional benefits.1 This is an important milestone after a long period of waiting for patients with severe shortness of breath for a new treatment that can help their symptoms, but, in the era of evidence-based medicine and strict regulations, we need to be absolutely sure that the treatment works and is not harmful. Was it worth the wait? Zephyr valves are the most studied devices for endoscopic lung volume reduction (ELVR), but are not the only devices for treating symptoms in chronic obstructive pulmonary disease (COPD) patients. The initial observations of safety with Zephyr valves, the need for new emphysema treatments, and the creativity of startup device companies open up the possibility of diversifying the ELVR options to different valves, coils, spigots, steam, and glue -all commercial ventures funded by the US capital market. Very recently, on December 5, 2018, the FDA announced the approval of Spiration valve system for the treatment of severe emphysema, which is similar to Zephyr technology, but with a differently designed valve.
机译:2018年6月29日,来自美国的食品和药物管理局(FDA)批准了Zephyr阀门,用于治疗与严重肺气肿有关的呼吸困难(www.accessdata.fda.gov/cdrh_docs/pdfl8 / p 180002a.pdf)。它发生了近15年后的案例系列,表明可以通过支气管镜下放置的肺部血管植入物在严重肺气肿的患者中实现肺部体积减少,具有可接受的短期安全和有价值的功能效益.1这是一个重要的里程碑很长一段时间等待患有严重呼吸急促的患者,可以帮助他们的症状,但是,在证据的药物时代和严格的法规中,我们需要绝对确定治疗工作,并不有害。值得等待吗? Zephyr阀是用于内窥镜肺体积减少(ELVR)的最多研究的装置,但不是用于治疗慢性阻塞性肺病(COPD)患者症状的唯一装置。初步观察安全性阀门,需要新的肺气肿治疗,以及启动装置公司的创造力开辟了不同阀门,线圈,尖端,蒸汽和胶水的榆树选项多样化的可能性美国资本市场。最近,2018年12月5日,FDA宣布批准消光阀系统,用于治疗严重的肺气肿,类似于Zephyr技术,但具有不同设计的阀门。

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