对某些肺气肿患者的肺部减少手术风险

——国家试验首次获得了谁应该接受手术的科学证据——

纽约，纽约2001年8月14日） - 国家肺气肿治疗试验（网站），其中哥伦比亚长老会医院的哥伦比亚长老会医院是一个重要的参与者，发现某些先进的肺气肿患者从肺部量受益于肺部减少手术（LVRS），并从程序中处于不可接受的死亡风险。网站试验 - 五年，多中心，随机研究，旨在评估LVRS在严重肺气肿治疗中的作用 - 表明那些具有严重肺阻塞的患者，具有有限的交换气体，同时呼吸或损坏在整个肺部均匀分布不应接受LVRS。这是研究人员第一次为寻求高级肺气肿的LVRS的患者识别科学的选择标准。因此，这些高风险特征的患者不再注册了网。然而，该研究将继续招募其他合格的患者，直到预定的2002年完成。“学习不进行肺粪体积减少手术，显然是网站的巨大福利之一，”斯坦特的主要调查员Mark Ginsburg博士说，哥伦比亚大学医师和外科医学院外科助理临床教授和胸部疾病中心外科医院，纽约高龄医院哥伦比亚长老医疗中心。“我们守卫希望其他患者LVR可能被证明是价值。”吉斯堡博士是医疗中心的胸外科副主任。“网站希望为提前肺气肿患者的LVRS界定LVRS的作用，”哥伦比亚大学医学院医学专家医学博士博士说，医学院医学专家和外科医生和参加哥伦比亚长老医疗中心的医生。 “The preliminary results released by the NHLBI established a subgroup of patients who do not benefit from LVRS Surgery. As the trial moves toward completion, investigators believe that scientifically based selection criteria for the procedure will be established.” Dr. Claude Lenfant, director of the National Heart, Lung, and Blood Institute (NHLBI), the primary sponsor of the study, said, “This is exactly the kind of insight we hope to gain from NETT. We expect the final results of NETT will guide us further in determining if and when this procedure should be used to treat emphysema.” The findings are being posted on the Web site of the New England Journal of Medicine (www.nejm.org.)八月十四日。由于研究结果的重要性，NEJM的编辑同意加快对研究结果的审查，并在未来几个月内印刷调查人员的报告之前将其发表在他们的互联网网站上。这是同类研究中规模最大的一项，NETT比较了LVRS与药物治疗对终末期肺气肿患者的安全性和有效性。这项研究还旨在更好地确定哪些人从LVRS中受益，哪些人在手术中面临过多的并发症或死亡风险。自1997年以来，有超过1000名来自17个临床站点的参与者在NETT登记。在肺气肿中，肺的精细结构被破坏，导致肺中出现大洞，气道阻塞，空气被困，氧交换困难。目前的医学治疗包括支持性措施，如药物治疗、运动康复和营养补充。LVRS是一种未被证实的缓解晚期肺气肿相关症状和改善整体肺功能的方法。一些人认为，通过手术切除每个肺的三分之一，以损伤最严重的区域为目标，预期剩余的肺将有更好的空气交换，从而提高空气进出肺部的能力。NETT是针对医药界和医疗保险和医疗补助服务中心(前卫生保健融资管理局)对LVRS与医疗治疗相比的风险和好处的担忧而建立的。 During its quarterly review of the study data in May 2001, the NETT Data and Safety Monitoring Board (DSMB) found that a subgroup of participants undergoing the procedure had a 30-day post-surgery death rate considered unacceptable based on the study’s safety and monitoring guidelines. The DSMB is a group of experts who are unaffiliated with NETT and who are responsible for overseeing participants’ safety and outcomes data. In addition, the NETT DSMB is charged with identifying subgroups of patients who may benefit from or be at high risk of dying from LVRS. As a result of the DSMB’s findings, NETT is no longer enrolling patients with severe obstruction in the lung as measured by a forced expiratory volume in one second less than or equal to 20 percent of predicted, plus one of the following characteristics: severe loss of lung surface area as measured by a diffusing capacity of less than 20 percent predicted or homogeneous damage to the lung -- that is, disease is evenly distributed throughout the lung, rather than being confined to certain areas. Of the 1,033 current participants, 140 (14%) met these high-risk criteria, 69 of whom underwent surgery as part of the trial. These patients had a 16% 30-day mortality rate. In contrast, no deaths were reported in the medical treatment group 30 days following the start of medical treatment. Furthermore, compared to similar participants who received only medical treatment, high-risk participants who survived the surgery were found to have only slightly improved functional outcomes and quality-of-life scores six months after enrolling in the study. In addition to NHLBI, which is part of the National Institutes of Health, NETT is supported by the Center for Medicare and Medicaid Services, which supports clinical services for the study, and the Agency for Healthcare Research and Quality. Emphysema is a disabling condition that affects approximately 2 million Americans, most of them over age 50. Typically caused by cigarettes, emphysema costs more than $2.5 billion in annual healthcare expenses and kills more than 16,000 people in the U.S. each year.

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