TY -的T1 -一个潜在的安全性和可行性研究计量CryoSpray (MCS)慢性支气管炎患者的慢性阻塞性肺病JF -欧洲呼吸杂志》乔和J - 10.1183/13993003.00556 -2020欧元SP - 2000556 AU -加纳,贾斯廷·L AU - Shaipanich Tawimas AU -哈特曼,Jorine E AU -奥尔顿,克里斯托弗·M AU - Caneja Cielito盟——Klooster Karin AU -桑顿,约翰AU -罪恶,并维盟——Slebos Dirk-Jan AU -沙阿,摘要N2 -背景目前没有批准的干预措施可以拮抗慢性支气管炎(CB)患者气道上皮化生和粘液分泌过多。Metered Cryospray (MCS)将液氮(LN2)输送到气管支气管气道，消融异常上皮，促进健康的粘膜再生。本研究的目的是评价MCS在CB中的可行性、有效性和安全性。方法选取FEV1为预期30-80%、服用最佳药物的患者。主要结果:可行性——治疗的完成;疗效-圣乔治呼吸问卷(SGRQ) 3个月变化;安全性—不良事件发生率(AEs)。次要结果:肺功能，运动能力，额外的病人报告结果(PROs)。结果35例患者行气管支气管树分期LN2治疗，男19例，女16例，年龄47 ~ 76岁，金级(3)、级(10)、级(22)。34例患者完成3次治疗，每次34·3±12·1分钟，间隔4-6周，1例在第一次治疗后退出。大约提供了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. ER -