REACH 试验：一项评估 Spiration® Valve 系统治疗严重肺气肿的安全性和有效性的随机对照试验。
The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration® Valve System in the Treatment of Severe Emphysema.
机构信息
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Peking University First Hospital, Beijing, China.
出版信息
Respiration. 2019;97(5):416-427. doi: 10.1159/000494327. Epub 2018 Dec 14.
BACKGROUND
Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors.
OBJECTIVES
The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema.
METHODS
Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment. A total of 107 subjects were randomized in a 2: 1 allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone).
RESULTS
The 3-month primary endpoint showed statistically significant improvement in forced expiratory volume in 1 s in the treatment group compared to the control group (0.104 ± 0.18 vs. 0.003 ± 0.15 L, p = 0.001), with the difference being durable through 6 months. Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL). Exercise function and quality of life measures improved in the treatment group, but showed a deterioration in the control group. The serious adverse event (SAE) rate was 33% in the treatment group and 24.2% in the control group. The predominance of SAEs were acute exacerbations of COPD in both groups. There was 1 death in the control group and no deaths in the treatment group.
CONCLUSION
The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile.
背景
慢性阻塞性肺疾病（COPD）已成为中国发病率和死亡率的主要原因，烟草烟雾、空气污染和职业生物危害是主要危险因素。
目的
REACH 试验是一项在中国进行的多中心、前瞻性、随机对照试验，旨在评估 Spiration® Valve System（SVS）与 COPD 伴严重肺气肿患者的标准医疗相比的安全性和有效性。
方法
对具有严重气流阻塞、过度充气和严重间裂完整性的间裂性肺气肿患者进行评估以纳入试验。共有 107 名患者按 2:1 的比例随机分为治疗组（SVS 瓣膜和药物治疗）或对照组（仅药物治疗）。
结果
3 个月的主要终点显示，与对照组相比，治疗组的 1 秒用力呼气量（FEV1）有统计学意义的改善（0.104±0.18 对 0.003±0.15 L，p=0.001），差异在 6 个月时仍持续存在。3 个月时（平均变化 684.4±686.7 mL）和 6 个月时（757.0±665.3 mL）达到了有统计学意义的靶叶体积减少。治疗组的运动功能和生活质量指标有所改善，但对照组则恶化。治疗组的严重不良事件（SAE）发生率为 33%，对照组为 24.2%。SAE 的主要类型为两组中的 COPD 急性加重。对照组有 1 例死亡，治疗组无死亡。
结论
SVS 为治疗严重肺气肿提供了一种新颖的方法，具有可接受的风险效益比。
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