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肺癌患者手术康复:PUREAIR 随机试验结果。

Rehabilitation for lung cancer patients undergoing surgery: results of the PUREAIR randomized trial.

机构信息

Unit of Thoracic Surgery, AUSL Reggio Emilia, Reggio Emilia, Italy.

Unit of Physical Medicine and Rehabilitation, AUSL Reggio Emilia, Reggio Emilia, Italy -

出版信息

Eur J Phys Rehabil Med. 2021 Dec;57(6):1002-1011. doi: 10.23736/S1973-9087.21.06789-7. Epub 2021 May 27.

Abstract

BACKGROUND

Surgery for non-small cell lung cancer is proven to be the most effective treatment in early stages, although concerns exist on its negative impact on patients' overall fitness.

AIM

To establish whether intensive pulmonary rehabilitation, preoperative and postoperative, improves exercise capacity in patients undergoing lung resection.

DESIGN

Single center, unblinded, designed for superiority, 1:1 randomized controlled trial with two parallel arms.

SETTING

S. Maria Nuova Hospital of Reggio Emilia (Reggio Emilia, Italy).

POPULATION

Patients referred from local lung cancer multidisciplinary team for lung resection.

METHODS

Patients were randomized to either standard of care (SC) or SC + intensive perioperative pulmonary rehabilitation (SC+PR). The primary aim was to investigate the effectiveness of pulmonary rehabilitation in improving exercise capacity six months after surgery. Additionally, we wanted to investigate the same effect shortly after surgery (at one month), as well as the overall impact of rehabilitation on lung function, postoperative complications and length of stay, quality of life, mood disturbances and pain. Sample was sized based on the primary outcome assuming a minimal clinically significant difference of 25 meters in exercise tolerance, measured with 6 minutes walking test.

RESULTS

The exercise tolerance at 6 months after surgery was significantly higher in patients undertaking PR compared to SC (+48.9 meters vs. -7.5 meters respectively, difference: +56.4 meters, 95% CI: 29.6-83.0, P<0.001) and it showed significantly lower impairment at 1 month after surgery in the intervention group (-3.0 meters vs. -30.1 meters difference: +27.1 meters, 95% CI: 3.4-50.8, P=0.025). No other significant differences between groups were found.

CONCLUSIONS

Comparison between groups showed that pulmonary rehabilitation, administered pre and postoperatively, significantly improved exercise capacity at 6 months in patients undergoing lung resection; it also significantly reduced the decrease in exercise tolerance observed 1 month after surgery.

CLINICAL REHABILITATION IMPACT

The PUREAIR trial highlights the importance of combined preoperative and postoperative rehabilitation in reducing physical deconditioning in lung cancer patients undergoing surgery. Comprehensive pulmonary rehabilitation improves exercise capacity at 1 and 6 months after surgery. The PUREAIR trial results increase knowledge on comprehensive rehabilitation's outcomes in the first six months after surgery.

摘要

背景

手术治疗非小细胞肺癌在早期阶段被证明是最有效的治疗方法,尽管人们对其对患者整体健康状况的负面影响仍存在担忧。

目的

确定术前和术后强化肺康复是否能提高接受肺切除术的患者的运动能力。

设计

单中心、非盲、设计用于优势、1:1 随机对照试验,有两个平行组。

地点

雷焦艾米利亚圣玛丽亚诺瓦医院(意大利雷焦艾米利亚)。

人群

从当地肺癌多学科团队转诊接受肺切除术的患者。

方法

患者被随机分配到标准护理(SC)或 SC+围手术期强化肺康复(SC+PR)。主要目的是调查肺康复在术后 6 个月改善运动能力的效果。此外,我们还想调查术后短期内(术后 1 个月)同样的效果,以及康复对肺功能、术后并发症和住院时间、生活质量、情绪障碍和疼痛的总体影响。根据假设 6 分钟步行试验测量的运动耐量有 25 米最小临床显著差异的主要结果,对样本量进行了估计。

结果

与 SC 组相比,接受 PR 的患者术后 6 个月的运动耐力显著提高(分别增加 48.9 米和减少 7.5 米,差异:增加 56.4 米,95%置信区间:29.6-83.0,P<0.001),并且在干预组中术后 1 个月的运动耐量下降显著减少(减少 3.0 米和减少 30.1 米,差异:增加 27.1 米,95%置信区间:3.4-50.8,P=0.025)。两组之间没有发现其他显著差异。

结论

组间比较表明,术前和术后给予肺康复治疗,可显著提高接受肺切除术的患者术后 6 个月的运动能力,同时也显著减少术后 1 个月观察到的运动耐力下降。

临床康复影响

PUREAIR 试验强调了术前和术后综合康复在减少接受手术的肺癌患者身体失能方面的重要性。综合肺康复可提高术后 1 个月和 6 个月的运动能力。PUREAIR 试验结果增加了术后 6 个月内综合康复治疗结果的知识。

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