Pulmonary Division, Rabin Medical Center, Beilinson Campus, 39 Jabotinski St, Petach-Tikva, 4941492, Israel.
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
BMC Pulm Med. 2024 May 10;24(1):226. doi: 10.1186/s12890-024-03051-4.
Inhaled nitric oxide (iNO) selectively acts on the pulmonary vasculature of ventilated lung tissue by reducing pulmonary vascular resistance and intrapulmonary shunt. This effect may reduce ventilation/perfusion mismatch and decrease pulmonary hypertension in patients with interstitial lung disease.
In a prospective, single-blinded, randomized, placebo-controlled trial, participants with advanced interstitial lung disease, underwent two separate six-minute walk tests (6MWT): one with iNO and the other with a placebo. The primary outcome measured the difference in meters between the distances covered in the two tests. Secondary outcomes included oxygen saturation levels, distance-saturation product, and Borg dyspnea score. A predefined subgroup analysis was conducted for patients with pulmonary hypertension.
Overall, 44 patients were included in the final analysis. The 6MWT distance was similar for iNO treatment and placebo, median 362 m (IQR 265-409) vs 371 m (IQR 250-407), respectively (p = 0.29). Subgroup analysis for patients with pulmonary hypertension showed no difference in 6MWT distance with iNO and placebo, median 339 (256-402) vs 332 (238-403) for the iNO and placebo tests respectively (P=0.50). No correlation was observed between mean pulmonary artery pressure values and the change in 6MWT distance with iNO versus placebo (spearman correlation Coefficient 0.24, P=0.33).
In patients with advanced interstitial lung disease, both with and without concurrent pulmonary hypertension, the administration of inhaled nitric oxide failed to elicit beneficial effects on the six-minute walk distance and oxygen saturation. The use of inhaled NO was found to be safe and did not lead to any serious side effects.
(NCT03873298, MOH_2018-04-24_002331).
吸入一氧化氮（iNO）通过降低肺血管阻力和肺内分流，选择性作用于通气肺组织的肺血管。这种作用可能会减少通气/灌注不匹配，并降低间质性肺疾病患者的肺动脉高压。
在一项前瞻性、单盲、随机、安慰剂对照试验中，患有晚期间质性肺疾病的患者进行了两次单独的 6 分钟步行测试（6MWT）：一次使用 iNO，另一次使用安慰剂。主要终点测量两次测试中覆盖距离的差异。次要终点包括氧饱和度水平、距离-饱和度产物和 Borg 呼吸困难评分。对肺动脉高压患者进行了预设的亚组分析。
总体而言，44 例患者纳入最终分析。6MWT 距离在 iNO 治疗和安慰剂治疗之间相似，中位数分别为 362m（IQR 265-409）和 371m（IQR 250-407）（p=0.29）。肺动脉高压患者的亚组分析显示，iNO 和安慰剂治疗的 6MWT 距离无差异，中位数分别为 339（256-402）和 332（238-403）（P=0.50）。iNO 与安慰剂相比，平均肺动脉压值与 6MWT 距离的变化之间没有相关性（斯皮尔曼相关系数 0.24，P=0.33）。
在患有晚期间质性肺疾病的患者中，无论是否同时患有肺动脉高压，吸入一氧化氮的治疗均未能对 6 分钟步行距离和氧饱和度产生有益影响。使用吸入 NO 被发现是安全的，不会导致任何严重的副作用。
（NCT03873298，MOH_2018-04-24_002331）。
