Zoumot Zaid, Kemp Samuel V, Singh Suveer, Bicknell Stephen R, McNulty William H, Hopkinson Nicholas S, Ross Ewen T, Shah Pallav L
The NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London, United Kingdom; Chelsea & Westminster Hospital NHS Foundation Trust, London, United Kingdom; Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.
The NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London, United Kingdom; Chelsea & Westminster Hospital NHS Foundation Trust, London, United Kingdom; Sherwood Forest Hospitals NHS Foundation Trust, Nottinghamshire, United Kingdom.
PLoS One. 2015 Apr 8;10(4):e0122656. doi: 10.1371/journal.pone.0122656. eCollection 2015.
There is a clinical need for therapeutic options to reduce hyperinflation associated with severe emphysema. Endobronchial Coils (coils) are nitinol devices implanted bronchoscopically under fluoroscopic guidance to re-tension the lung. We report the medium term effectiveness and safety of coils in a study of patients with emphysema.
Forty five subjects with severe airflow obstruction and hyperinflation received bilateral sequential treatment with coils (30 day interval between treatments) as part of a randomised controlled trial with a primary endpoint 90 days after the final treatment (Clinicaltrials.gov NCT01334307). Further assessments were made at 180 and 360 days and in this study the primary outcome was the effect of coil treatment on the St. George's Respiratory Questionnaire (SGRQ) 360 days following treatment.
At 360 days following treatment, there was an improvement in the SGRQ score of -6.1±14.0 points (p = 0.01) compared to baseline. Improvements in secondary outcomes were seen with increases in forced expiratory volume in the first second of 8.9 ±22.2% (p = 0.002) and 6-minute walking distance of 34.1±52.4m (p = 0.003). The safety profile was acceptable out to 360 days post-treatment.
Statistically and clinically meaningful benefits in quality of life, exercise capacity and pulmonary function in patients treated with coils are sustained twelve months after treatment.
Clinicaltrials.gov NCT01334307.
临床上需要有治疗方案来减轻与重度肺气肿相关的肺过度充气。支气管内线圈是一种镍钛诺装置，在荧光镜引导下通过支气管镜植入，以使肺重新张紧。我们在一项针对肺气肿患者的研究中报告了线圈的中期有效性和安全性。
45名患有严重气流阻塞和肺过度充气的受试者接受了双侧序贯线圈治疗（治疗间隔30天），这是一项随机对照试验的一部分，主要终点为最后一次治疗后90天（Clinicaltrials.gov NCT01334307）。在180天和360天时进行了进一步评估，在本研究中，主要结局是线圈治疗对治疗后360天圣乔治呼吸问卷（SGRQ）的影响。
治疗后360天，与基线相比，SGRQ评分改善了-6.1±14.0分（p = 0.01）。次要结局也有改善，第一秒用力呼气量增加了8.9±22.2%（p = 0.002），6分钟步行距离增加了34.1±52.4米（p = 0.003）。治疗后360天的安全性良好。
接受线圈治疗的患者在生活质量、运动能力和肺功能方面在统计学和临床上都有显著益处，且在治疗后12个月仍持续存在。
Clinicaltrials.gov NCT01334307。
