Kaplan Robert M, Sun Qiankun, Naunheim Keith S, Ries Andrew L
Department of Rehabilitation Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland.
Department of Rehabilitation Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland.
Ann Thorac Surg. 2014 Nov;98(5):1782-9. doi: 10.1016/j.athoracsur.2014.06.031. Epub 2014 Sep 4.
The National Emphysema Treatment Trial (NETT) was a randomized clinical trial designed to compare lung volume reduction surgery (LVRS) with maximal medical care for patients with severe emphysema. The trial was halted early for a subgroup of patients with severe lung disease. We report longer term follow-up for this high-risk subgroup.
In a randomized clinical trial, patients with moderate to severe emphysema were assigned to LVRS plus maximal medical care or to maximal medical care alone and followed prospectively for vital status over 15 years. We focus on 140 high-risk patients. Quality of life data were available through 6 years of follow-up and were assessed using the University of California, San Diego Shortness of Breath Questionnaire and the Self-Administered Quality of Well-Being Scale.
Through the first 3 years of follow-up, surgical patients in the high-risk subgroup had a significantly higher probability of death. However, the mortality curves crossed and there was a trend favoring surgical treatment through the remainder of the follow-up. The log-rank test suggested that the 2 groups were not significantly different (p=0.95) in survival. Quality of life data suggested an advantage of LVRS through the first 5 years of follow-up (p<0.01). The combined quality-adjusted survival model favored the medical group for the first few years of follow-up and favored the LVRS group after 4 years.
The NETT was stopped early for high-risk patients with severe lung disease. Longer term follow-up suggests that surgical patients in this high-risk subgroup ultimately achieved comparable outcomes. The high risk of death within 30 days of the surgery may discourage use of the procedure for high-risk patients despite the potential for better long-term outcomes.
国家肺气肿治疗试验（NETT）是一项随机临床试验，旨在比较肺减容手术（LVRS）与针对重度肺气肿患者的最佳药物治疗。该试验因一组严重肺部疾病患者而提前终止。我们报告了这个高危亚组的长期随访情况。
在一项随机临床试验中，中度至重度肺气肿患者被分配接受LVRS加最佳药物治疗或仅接受最佳药物治疗，并对其进行了15年的前瞻性生命状态随访。我们重点关注140名高危患者。通过6年的随访可获得生活质量数据，并使用加利福尼亚大学圣地亚哥分校呼吸急促问卷和自我管理的幸福质量量表进行评估。
在随访的前3年，高危亚组中的手术患者死亡概率显著更高。然而，死亡率曲线交叉，并且在随访的剩余时间里有倾向于手术治疗的趋势。对数秩检验表明两组在生存率方面无显著差异（p = 0.95）。生活质量数据表明在随访的前5年LVRS具有优势（p < 0.01）。综合质量调整生存模型在随访的最初几年有利于药物治疗组，而在4年后有利于LVRS组。
NETT因严重肺部疾病的高危患者而提前终止。长期随访表明，这个高危亚组中的手术患者最终取得了相当的结果。尽管手术有更好的长期结果的潜力，但手术30天内的高死亡风险可能会阻碍高危患者使用该手术。
