Lundin S, Mang H, Smithies M, Stenqvist O, Frostell C
Department of Anaesthesia and Intensive Care, Sahlgrenska University Hospital, S-413 45 Göteborg, Sweden.
Intensive Care Med. 1999 Sep;25(9):911-9. doi: 10.1007/s001340050982.
To determine whether inhalation of nitric oxide (INO) can increase the frequency of reversal of acute lung injury (ALI) in nitric oxide (NO) responders.
Prospective, open, randomised, multicentre, parallel group phase III trial.
General ICUs in 43 university and regional hospitals in Europe.
Two hundred and sixty-eight adult patients with early ALI.
NO responders were patients whose PaO(2) increased by more than 20 % when receiving 0, 2, 10 and 40 ppm of INO for 10 min within 96 h of study entry. Responders were randomly allocated to conventional treatment with or without INO. INO, 1-40 ppm, was given at the lowest effective dose for up to 30 days or until an end point was reached. The primary end point was reversal of ALI. Clinical outcome parameters and safety were assessed in all patients.
Two hundred and sixty-eight patients were recruited, of which 180 were randomised NO responders. Frequency of reversal of ALI was no different in INO patients (61 %) and controls (54 %; p > 0.2). Development of severe respiratory failure was lower in the INO (2.2 % ) than controls (10.3 %; p < 0.05). The mortality at 30 days was 44 % for INO patients, 40 % for control patients (p > 0.2 vs INO) and 45 % in non-responders.
Improvement of oxygenation by INO did not increase the frequency of reversal of ALI. Use of inhaled NO in early ALI did not alter mortality although it did reduce the frequency of severe respiratory failure in patients developing severe hypoxaemia.
确定吸入一氧化氮（INO）能否增加一氧化氮（NO）反应者急性肺损伤（ALI）逆转的频率。
前瞻性、开放性、随机、多中心、平行组III期试验。
欧洲43所大学和地区医院的普通重症监护病房。
268例早期ALI成年患者。
NO反应者是指在研究入组96小时内接受0、2、10和40 ppm的INO治疗10分钟时，其动脉血氧分压（PaO₂）升高超过20%的患者。反应者被随机分配接受含或不含INO的常规治疗。INO剂量为1 - 40 ppm，以最低有效剂量给药，最长30天或直至达到终点。主要终点是ALI的逆转。对所有患者评估临床结局参数和安全性。
共招募268例患者，其中180例为随机分组的NO反应者。INO组患者ALI逆转的频率（61%）与对照组（54%；p>0.2）无差异。INO组严重呼吸衰竭的发生率（2.2%）低于对照组（10.3%；p<0.05）。INO组患者30天死亡率为44%，对照组患者为40%（与INO组相比p>0.2），无反应者为45%。
INO改善氧合并未增加ALI逆转的频率。早期ALI患者使用吸入性NO虽未改变死亡率，但确实降低了发生严重低氧血症患者的严重呼吸衰竭频率。
