一项随机、多中心、盲法初步研究评估气态一氧化氮在人肺离体系统中的作用。

IF 2.3 Q2 RESPIRATORY SYSTEM

Pulmonary Therapy Pub Date : 2023-03-01 DOI:10.1007/s41030-022-00209-5

Matthew G Hartwig, Jacob A Klapper, Nagaraju Poola, Amit Banga, Pablo G Sanchez, John S Murala, Jim L Potenziano

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引用次数: 0

摘要

常温离体肺灌注(EVLP)用于评估和调节供肺移植。本研究的目的是确定EVLP期间外源性一氧化氮的施用是否有助于改善肺部健康。方法:一项多中心、盲法、双臂、随机先导研究评估了EVLP期间给予气态一氧化氮(gNO)对供体肺移植排斥反应的影响。将以百万分之80 (ppm)的浓度引入灌注液中的一氧化氮(gNO)与单独灌注液(P)进行比较。一项开放标签亚研究评估了通过呼吸机以百万分之20的浓度输送到肺部的吸入一氧化氮气体(iNO)。主要终点为肺生理指标的总评分和EVLP稳定时间的总持续时间。次要终点包括评估肺重量和左心房氧分压(LAPO2)。结果:20双侧供体肺(盲法研究，n = 16;来自三个中心的开放标签亚研究(n = 4)被纳入。gNO、P和iNO组EVLP总时间中位数(min、max)分别为12.4(8.6、12.6)、10.6(6.0、12.4)和12.4(8.7、13.0)小时。在盲法研究中，与P组相比，gNO组在大多数时间点的中位总得分更高，表明gNO组肺健康状况更好(中位得分范围[min, max]， 0-3.5[0,7])，而P组(研究结束时0-2.0[0,5])。在亚研究中，iNO组肺部的中位总评分没有改善。然而，与P组相比，gNO和iNO组肺重量和LAPO2均有改善。结论:数据表明，在EVLP中加入gNO可能会延长器官稳定时间，改善供体肺健康，值得进一步研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

A Randomized, Multicenter, Blinded Pilot Study Assessing the Effects of Gaseous Nitric Oxide in an Ex Vivo System of Human Lungs.

查看原文本刊更多论文

A Randomized, Multicenter, Blinded Pilot Study Assessing the Effects of Gaseous Nitric Oxide in an Ex Vivo System of Human Lungs.

Introduction: Normothermic ex vivo lung perfusion (EVLP) is used to evaluate and condition donor lungs for transplantation. The objective of this study was to determine whether administration of exogenous nitric oxide during EVLP contributes to improvement of lung health.

Methods: A multicenter, blinded, two-arm, randomized pilot study evaluated the effect of gaseous nitric oxide (gNO) administered during EVLP on donor lungs rejected for transplantation. gNO introduced into the perfusate at 80 parts per million (ppm) was compared with perfusate alone (P). An open-label substudy assessed inhaled nitric oxide gas (iNO) delivered into the lungs at 20 ppm via a ventilator. Primary endpoints were an aggregate score of lung physiology indicators and total duration of stable EVLP time. Secondary endpoints included assessments of lung weight and left atrium partial pressure of oxygen (LAPO₂).

Results: Twenty bilateral donor lungs (blinded study, n = 16; open-label substudy, n = 4) from three centers were enrolled. Median (min, max) total EVLP times for the gNO, P, and iNO groups were 12.4 (8.6, 12.6), 10.6 (6.0, 12.4), and 12.4 (8.7, 13.0) hours, respectively. In the blinded study, median aggregate scores were higher in the gNO group compared to the P group at most time points, suggesting better lung health with gNO (median score range [min, max], 0-3.5 [0, 7]) vs. P (0-2.0 [0, 5] at end of study). In the substudy, median aggregate scores did not improve for lungs in the iNO group. However, both the gNO and iNO groups showed improvements in lung weight and LAPO₂ compared to the P group.

Conclusions: The data suggest that inclusion of gNO during EVLP may potentially prolong duration of organ stability and improve donor lung health, which warrants further investigation.

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来源期刊

Pulmonary Therapy Medicine-Pulmonary and Respiratory Medicine

CiteScore

5.20

自引率

3.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Pulmonary Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the use of pulmonary therapies, devices, and surgical techniques. Areas of focus include, but are not limited to: asthma; chronic obstructive pulmonary disease; idiopathic pulmonary fibrosis; pulmonary hypertension; cystic fibrosis; lung cancer; respiratory tract disorders; allergic rhinitis and other respiratory allergies; influenza, pneumococcal infection, respiratory syncytial virus and other respiratory infections; and inhalers and other device therapies. 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