A Randomized Study of Endobronchial Valves for Advanced Emphysema
A Randomized Study of Endobronchial Valves for Advanced Emphysema
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DOI：
10.1056/nejmoa0900928
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发表时间：
2010-09-23
影响因子：
158.5
通讯作者：
McLennan, Geoffrey
中科院分区：
文献类型：
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作者：
Sciurba, Frank C.;Ernst, Armin;McLennan, Geoffrey
背景：允许空气从肺叶逸出而不进入肺叶的支气管瓣膜可引起肺叶体积的减少，从而改善晚期肺气肿相关的肺高膨胀患者的肺功能和运动耐受性。方法比较支气管内瓣膜治疗非均质肺气肿与常规治疗的安全性和有效性。疗效终点为1秒用力呼气量（FEV1）变化百分比和意向治疗分析的6分钟步行测试。我们根据六种主要并发症的综合发生率来评估安全性。结果321例入组患者中，随机分为接受支气管内瓣膜治疗的220例（EBV组）和接受标准医疗护理的101例（对照组）。在6个月时，EBV组的FEV1增加了4.3%（占预测值的百分比增加了1.0个百分点），而对照组的FEV1减少了2.5%（占预测值的百分比减少了0.9个百分点）。因此，FEV1组间平均差异为6.8% （P = 0.005）。在6分钟步行测试中观察到的组间差异大致相似。12个月时，EBV组并发症综合发生率为10.3%，对照组为4.6% （P = 0.17）。在第90天，与对照组相比，EBV组慢性阻塞性肺疾病（COPD）加重需要住院治疗的比率增加（7.9%对1.1%,P = 0.03），咯血率增加（6.1%对0%，P = 0.01）。EBV组12个月时靶叶肺炎发生率为4.2%。更多的肺气肿异质性和裂隙完整性的影像学证据与治疗反应增强相关。结论经支气管瓣膜治疗晚期异质性肺气肿可诱导肺功能、运动耐量和症状的适度改善，但代价是植入后COPD、肺炎和咯血的更频繁加重。
BACKGROUNDEndobronchial valves that allow air to escape from a pulmonary lobe but not enter it can induce a reduction in lobar volume that may thereby improve lung function and exercise tolerance in patients with pulmonary hyperinflation related to advanced emphysema.METHODSWe compared the safety and efficacy of endobronchial-valve therapy in patients with heterogeneous emphysema versus standard medical care. Efficacy end points were percent changes in the forced expiratory volume in 1 second (FEV1) and the 6-minute walk test on intention-to-treat analysis. We assessed safety on the basis of the rate of a composite of six major complications.RESULTSOf 321 enrolled patients, 220 were randomly assigned to receive endobronchial valves (EBV group) and 101 to receive standard medical care (control group). At 6 months, there was an increase of 4.3% in the FEV1 in the EBV group (an increase of 1.0 percentage point in the percent of the predicted value), as compared with a decrease of 2.5% in the control group (a decrease of 0.9 percentage point in the percent of the predicted value). Thus, there was a mean between-group difference of 6.8% in the FEV1 (P = 0.005). Roughly similar between-group differences were observed for the 6-minute walk test. At 12 months, the rate of the complications composite was 10.3% in the EBV group versus 4.6% in the control group (P = 0.17). At 90 days, in the EBV group, as compared with the control group, there were increased rates of exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization (7.9% vs. 1.1%, P = 0.03) and hemoptysis (6.1% vs. 0%, P = 0.01). The rate of pneumonia in the target lobe in the EBV group was 4.2% at 12 months. Greater radiographic evidence of emphysema heterogeneity and fissure completeness was associated with an enhanced response to treatment.CONCLUSIONSEndobronchial-valve treatment for advanced heterogeneous emphysema induced modest improvements in lung function, exercise tolerance, and symptoms at the cost of more frequent exacerbations of COPD, pneumonia, and hemoptysis after implantation.