Patients at high risk of death after lung-volume-reduction surgery.
Patients at high risk of death after lung-volume-reduction surgery.
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肺减容手术后死亡风险较高的患者。
DOI：
10.1056/nejmoa11798
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发表时间：
2001
期刊：
影响因子：
--
通讯作者：
Wise,Robert
中科院分区：
文献类型：
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作者：
NationalEmphysemaTreatmentTrialResearchGroup;Fishman,Alfred;Fessler,Henry;Martinez,Fernando;McKennaJr,RobertJ;Naunheim,Keith;Piantadosi,Steven;Weinmann,Gail;Wise,Robert
背景肺减容术是肺气肿的一种治疗方法，但最佳选择标准尚未确定。国家肺气肿治疗试验是一项随机，多中心临床试验比较肺减容手术与药物治疗。MethodsAfter评估和肺康复，我们随机分配患者进行肺减容手术或接受药物治疗。一个独立的数据和安全监测board.ResultsA共1033例患者进行了随机化，2001年6月的结果进行了监测。对于69名一秒钟用力呼气量（FEV 1）不超过其预测值20%，并且在计算机断层扫描上肺气肿分布均匀或一氧化碳弥散量不超过其预测值20%的患者，术后30天死亡率为16（95%置信区间，8.2%至26.7%），而在70名接受药物治疗的患者中，这一比例为0%（P<0.001）。在这些高危患者中，手术患者的总体死亡率高于内科患者（0.43例死亡/人年vs. 0.11例死亡/人年;相对风险为3.9; 95%置信区间为1.9至9.0）。与药物治疗的患者相比，手术幸存者在6个月时的最大工作量（P=0.06）、6分钟步行距离（P=0.03）和FEV 1（P<0.001）方面略有改善，但与健康相关的生活质量相似。所有患者的功能结局的分析结果，占死亡和缺失的数据，并不有利于任何treatment.ConclusionsCaution是必要的肺气肿患者肺减容手术中使用低FEV 1和均匀的肺气肿或一氧化碳弥散能力非常低。这些患者在手术后死亡的风险很高，也不太可能从手术中受益。
BackgroundLung-volume–reduction surgery is a proposed treatment for emphysema, but optimal selection criteria have not been defined. The National Emphysema Treatment Trial is a randomized, multicenter clinical trial comparing lung-volume–reduction surgery with medical treatment.MethodsAfter evaluation and pulmonary rehabilitation, we randomly assigned patients to undergo lung-volume–reduction surgery or receive medical treatment. Outcomes were monitored by an independent data and safety monitoring board.ResultsA total of 1033 patients had been randomized by June 2001. For 69 patients who had a forced expiratory volume in one second (FEV1) that was no more than 20 percent of their predicted value and either a homogeneous distribution of emphysema on computed tomography or a carbon monoxide diffusing capacity that was no more than 20 percent of their predicted value, the 30-day mortality rate after surgery was 16 percent (95 percent confidence interval, 8.2 to 26.7 percent), as compared with a rate of 0 percent among 70 medically treated patients (P<0.001). Among these high-risk patients, the overall mortality rate was higher in surgical patients than medical patients (0.43 deaths per person-year vs. 0.11 deaths per person-year; relative risk, 3.9; 95 percent confidence interval, 1.9 to 9.0). As compared with medically treated patients, survivors of surgery had small improvements at six months in the maximal workload (P=0.06), the distance walked in six minutes (P=0.03), and FEV1(P<0.001), but a similar health-related quality of life. The results of the analysis of functional outcomes for all patients, which accounted for deaths and missing data, did not favor either treatment.ConclusionsCaution is warranted in the use of lung-volume–reduction surgery in patients with emphysema who have a low FEV1and either homogeneous emphysema or a very low carbon monoxide diffusing capacity. These patients are at high risk for death after surgery and also are unlikely to benefit from the surgery.