@article {Garner2000556,笔者= {加纳,贾斯汀·L和Shaipanich,Tawimas和哈特曼,Jorine E和奥顿,克里斯托弗·M和Caneja,谢利托和克卢斯特,卡琳和桑顿,约翰和仙,唐d和Slebos,德克 - 扬和沙阿Pallav L},标题= {用于慢性支气管炎慢性阻塞性肺病},elocation-ID = {2000556},年= {2020},DOI = {10.1183 / 13993003.00556患者计量CryoSpray(MCS)的前瞻性安全性和可行性研究-2020},出版商= {欧洲呼吸学会},188bet官网地址抽象= {背景目前没有批准的干预抵消气道上皮化生和黏液在COPD慢性支气管炎(CB)的高分泌。计量Cryospray(MCS)输送液体氮(LN2)到气管支气管气道消融异常上皮细胞和促进健康的粘膜再生。这项研究的目的是用FEV1来评价CB.Methods患者的可行性,有效性和MCS的安全,30 {\ textendash}预期的80 \%,占最佳药物被招募。主要成果:可行性{\ textendash}的处理完成;功效{\ textendash}圣乔治{\ textquoteright} 3个月的变化的呼吸问卷(SGRQ);安全性不良事件(AE)的{\ textendash}发生。次要结果:肺功能,运动能力,附加的患者报告结果(PROS)。结果35例,男性19/16女性,年龄47 {\ textendash} 76岁,GOLD等级I(3),II(10)和III(22),后行交错LN2处理以气管支气管tree.34患者完成三次治疗,每次持续34 {\ textperiodcentered} 3 {\ textpm} 12 {\ textperiodcentered} 1分钟,由4 {\ textendash}分离6周:一个第一次治疗后退出。 Approximately 1800 doses of MCS were delivered.Clinically meaningful improvements in PROs were observed at 3-months; ΔSGRQ -6{\textperiodcentered}4 [95\% CI -11.4, -1.3; p=0{\textperiodcentered}01], COPD Assessment Test (CAT) -3{\textperiodcentered}8 [95\% CI -6.4, -1.3; p\<0{\textperiodcentered}01] and Leicester Cough Questionnaire (LCQ) 21{\textperiodcentered}6 [95\% CI 7.3, 35.9; p\<0{\textperiodcentered}01]. CAT changes were durable to 6-months (-3{\textperiodcentered}4 [95\% CI -5.9, -0.9; p=0{\textperiodcentered}01]), SGRQ and LCQ to 9-months (-6{\textperiodcentered}9 [95\% CI -13.0, -0.9; p=0{\textperiodcentered}03] and 13{\textperiodcentered}4 [95\% 2.1, 24.6; p=0{\textperiodcentered}02], respectively).At 12-months, 14 serious AEs were recorded in 11 (31{\textperiodcentered}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.}, issn = {0903-1936}, URL = {//www.qdcxjkg.com/content/early/2020/06/25/13993003.00556-2020}, eprint = {//www.qdcxjkg.com/content/early/2020/06/25/13993003.00556-2020.full.pdf}, journal = {European Respiratory Journal} }