A1 Garner, Justin L A1 Shaipanich, Tawimas A1 Hartman, Jorine E A1 Orton, Christopher M A1 Caneja, Cielito A1 Klooster, Karin A1 Thornton, John A1 Sin, Don D A1 Slebos, Dirk-Jan A1 Shah,188bet官网地址Pallav L YR 2020 UL //www.qdcxjkg.com/content/early/2020/06/25/13993003.00556-2020.abstract AB背景目前还没有批准的干预措施对抗COPD慢性支气管炎(CB)的气道化生和粘液高分泌。计量冷冻喷雾(MCS)输送液氮(LN2)到气管支气管气道消融异常上皮和促进健康的粘膜再生。本研究的目的是评估MCS治疗CB的可行性、有效性和安全性。方法选取FEV1为预期值30 ~ 80%、服用最佳药物的患者。主要结果:可行性-完成治疗;疗效-圣乔治呼吸问卷(SGRQ) 3个月的变化;安全性——不良事件(AEs)的发生率。次要预后:肺功能、运动能力、其他患者报告预后(PROs)。结果35例患者行气管支气管交错LN2治疗,男19例,女16例,年龄47 ~ 76岁,GOLD分级I级(3例)、II级(10例)、III级(22例)。34例患者完成3次治疗,每次治疗时间为33.4±12.1 min,间隔4-6周:1例患者在第一次治疗后退出。共注射了约1800剂MCS。Clinically meaningful improvements in PROs were observed at 3-months; ΔSGRQ −6·4 [95% CI −11.4, −1.3; p=0·01], COPD Assessment Test (CAT) −3·8 [95% CI −6.4, −1.3; p<0·01] and Leicester Cough Questionnaire (LCQ) 21·6 [95% CI 7.3, 35.9; p<0·01]. CAT changes were durable to 6-months (−3·4 [95% CI −5.9, −0.9; p=0·01]), SGRQ and LCQ to 9-months (−6·9 [95% CI −13.0, −0.9; p=0·03] and 13·4 [95% 2.1, 24.6; p=0·02], respectively).At 12-months, 14 serious AEs were recorded in 11 (31·4%) subjects, 6 moderate (43%) and 8 severe (57%). 9 were respiratory-related: 6 exacerbations of COPD, 2 pneumonias, and 1, increased coughing, recovered without sequelae. None were serious device or procedure-related AEs.Conclusion MCS is safe, feasible and associated with clinically meaningful improvements in multidimensional PROs.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Garner has nothing to disclose.Conflict of interest: Dr. Shaipanich has nothing to disclose.Conflict of interest: Dr. Hartman has nothing to disclose.Conflict of interest: Dr. Orton has nothing to disclose.Conflict of interest: Ms Caneja has nothing to disclose.Conflict of interest: Dr. Klooster has nothing to disclose.Conflict of interest: Dr. Klooster has nothing to disclose.Conflict of interest: Dr. Klooster has nothing to disclose.Conflict of interest: Dr. Slebos reports grants, non-financial support and other from CSA Medical, USA, during the conduct of the study; grants, non-financial support and other from PulmonX, USA, grants, non-financial support and other from Nuvaira, USA, grants, non-financial support and other from PneumRx/BTG, USA, other from FreeFlowMedical, USA, outside the submitted work; .Conflict of interest: Professor Shah was reimbursed for travel expenses incurred during the training with the medical device and trial protocol development. The hospital was reimbursed for all clinical trial related costs.