抽象的
Background目前尚无批准的干预措施抵消COPD中慢性支气管炎的气道化学和粘液过度分泌。然而,计量的冷冻喷雾(MCS)将液氮输送到气管机管气道植物异常上皮,并促进健康的粘膜再生。这项研究的目的是评估MC在慢性支气管炎中的可行性,功效和安全性。
方法Patients with a forced expiratory volume in 1 s of 30–80% predicted who were taking optimal medication were recruited. Primary outcomes were feasibility (completion of treatments), efficacy (3-month change in St George's Respiratory Questionnaire (SGRQ)) and safety (incidence of adverse events). Secondary outcomes were lung function, exercise capacity and additional patient-reported outcomes.
结果35 patients, 19 male/16 female, aged 47–76 years, Global Initiative for Chronic Obstructive Lung Disease grade I (n=3), II (n=10) and III (n=22), underwent staggered liquid nitrogen treatments to the tracheobronchial tree. 34 patients completed three treatments, each lasting 34.3±12.1 min, separated by 4–6 weeks; one withdrew after the first treatment. ∼1800 doses of MCS were delivered. Clinically meaningful improvements in patient-reported outcomes were observed at 3 months: change in SGRQ −6.4 (95% CI −11.4 to −1.3; p=0.01), COPD Assessment Test (CAT) −3.8 (95% CI −6.4 to −1.3; p<0.01) and Leicester Cough Questionnaire (LCQ) 21.6 (95% CI 7.3 to 35.9; p<0.01). Changes in CAT were durable to 6 months (−3.4, 95% CI −5.9 to −0.9; p=0.01); changes in SGRQ and LCQ were durable to 9 months (−6.9, 95% CI −13.0 to −0.9; p=0.03 and 13.4, 95% CI 2.1 to 24.6; p=0.02, respectively. At 12 months, 14 serious adverse events were recorded in 11 (31.4%) subjects; six (43%) moderate and eight (57%) severe. Nine were respiratory-related: six exacerbations of COPD, two pneumonias and one case of increased coughing; all recovered without sequelae. None were serious device- or procedure-related adverse events.
结论MCS is safe, feasible and associated with clinically meaningful improvements in multidimensional patient-reported outcomes.
抽象的
COPD中慢性支气管炎患者的Rejuvenair系统治疗安全,可行,耐受性良好,并在临床上有意义地改善了咳嗽,痰液产生,呼吸困难和生活质量的多维测量https://bit.ly/30kbfps
脚注
本文具有可用的补充材料www.qdcxjkg.com
作者贡献:J.L。Garner是第一作者;与P.L.一起编写了第一份手稿草稿莎阿招募,治疗和随访患者。T. Shaipanich为手稿的写作/修订做出了贡献;招募,治疗和随访患者。J.E. Hartman为手稿的写作/修订做出了贡献;招募和跟进患者。厘米。奥顿为手稿的写作/修订做出了贡献; recruited and followed-up patients. C. Caneja contributed to writing/revisions of the manuscript; recruited and followed-up patients. K. Klooster contributed to writing/revisions of the manuscript; recruited and followed-up patients. J. Thornton contributed to writing/revisions of the manuscript; treated patients. D.D. Sin contributed to writing/revisions of the manuscript; recruited, treated and followed-up patients. D.J. Slebos contributed to writing/revisions of the manuscript; recruited, treated and followed-up patients. P.L Shah is the senior author; wrote the first manuscript draft together with J.L. Garner; recruited, treated and followed-up patients.
Support statement: This work was supported by CSA Medical. Funding information for this article has been deposited with theCrossRef资助人注册表.
利益冲突:J.L。Garner没有什么可披露的。
利益冲突:T。Shaipanich没有什么可披露的。
利益冲突:J.E。Hartman没有什么可披露的。
利益冲突:C.M.奥顿没有什么可披露的。
利益冲突:C。Caneja没有什么可披露的。
利益冲突:K。Klooster没有什么可披露的。
利益冲突:J。Thornton没有什么可披露的。
Conflict of interest: D.D. Sin has received honoraria for speaking engagements from AstraZeneca and Boehringer Ingelheim, and funding for research projects from AstraZeneca, Boehringer Ingelheim and Merck.
Conflict of interest: D.J. Slebos reports grants and non-financial support from, and was PI for and advisor to CSA Medical, USA, during the conduct of the study; grants and non-financial support from, and was PI for and advisor to PulmonX, USA, Nuvaira, USA and PneumRx/BTG, USA, and was PI for and advisor to FreeFlowMedical, USA, outside the submitted work.
Conflict of interest: P.L Shah was reimbursed by CSA Medical 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, and reports personal fees from CSA Medical, Boston Scientific, Broncus, Creo Medical, Nuvaira, Olympus, Medtronic and PneumRX/BTG as consultant on scientific advisory board; and sponsorship to Imperial College for a bronchoscopy course from ERBE, Cook medical, Medtronic, Boston Scientific, Broncus, Pulmonx, Olympus and PneumRX/BTG, outside the submitted work.
- 已收到2020年3月7日。
- AcceptedJune 11, 2020.
- 复制right ©ERS 2020
This version is distributed under the terms of the Creative Commons Attribution Licence 4.0.