Dellinger R Phillip, Trzeciak Stephen W, Criner Gerard J, Zimmerman Janice L, Taylor Robert W, Usansky Helen, Young Joseph, Goldstein Brahm
Division of Critical Care Medicine, Department of Medicine, Cooper University Hospital, 1 Cooper Plaza, Camden, NJ 08103, USA.
Crit Care. 2012 Dec 12;16(2):R36. doi: 10.1186/cc11215.
Assessment of treatments for acute respiratory distress syndrome (ARDS) has focused on short-term outcomes (for example, mortality); little information exists regarding long-term effects of ARDS treatment. Survivors of ARDS episodes may have long-term obstructive/restrictive pulmonary abnormalities and pulmonary gas exchange impairment. A 2004 prospective randomized placebo-controlled trial assessed the efficacy and safety of inhaled nitric oxide (iNO) in patients with non-septic ARDS; the primary endpoint was days alive and off assisted breathing. This analysis examined potential effects of iNO or placebo on pulmonary function six months post-treatment in ARDS survivors from that original study.
ARDS survivors (N = 92) from a large-scale randomized, placebo-controlled study evaluating mortality after either 5 ppm iNO or placebo for up to 28 days were assessed six months post-treatment. Pulmonary function testing across seven parameters was conducted.
At 6 months post-treatment, results indicated significantly better absolute values for iNO versus placebo for mean ± SD total lung capacity (TLC, 5.54 ± 1.42 vs. 4.81 ± 1.00; P = 0.026). There were also significantly better values for mean ± SD percent predicted values for a) forced expiratory volume in 1 second (FEV1, 80.23 ± 21.21 vs. 69.51 ± 28.97; P = 0.042), b) forced vital capacity (FVC, 83.78 ± 19.37 vs. 69.84 ± 27.40; P = 0.019), c) FEV1/FVC (96.14 ± 13.79 vs. 87.92 ± 19.77; P = 0.033), and d) TLC (93.33 ± 18.21 vs. 76.10 ± 21.84; P < 0.001). Nonsignificant differences were found in absolute FEV1, FEV1/FVC, FVC, forced expiratory flow from 25% to 75% of FVC, functional residual capacity, and CO diffusion.
ARDS patients surviving after treatment with low-dose iNO had significantly better values for select pulmonary function tests at six months post-treatment than placebo-treated patients. Further trials are warranted to determine the effects of iNO on chronic lung function in ARDS survivors, a factor in long-term morbidity and quality of life in this population.
A Double-blind, Randomized, Placebo-controlled, Dose-response Study of Inhaled Nitric Oxide in the Treatment of Acute Respiratory Distress Syndrome. NCT number: ISRCTN53268296.
急性呼吸窘迫综合征（ARDS）治疗评估主要集中在短期结果（如死亡率）；关于ARDS治疗的长期影响的信息很少。ARDS发作的幸存者可能有长期的阻塞性/限制性肺部异常和肺气体交换受损。一项2004年的前瞻性随机安慰剂对照试验评估了吸入一氧化氮（iNO）在非感染性ARDS患者中的疗效和安全性；主要终点是存活且脱离辅助呼吸的天数。本分析研究了iNO或安慰剂对该原始研究中ARDS幸存者治疗后6个月肺功能的潜在影响。
对一项大规模随机、安慰剂对照研究中的ARDS幸存者（N = 92）进行评估，该研究评估了5 ppm iNO或安慰剂治疗长达28天的死亡率，在治疗后6个月进行评估。进行了七个参数的肺功能测试。
治疗后6个月，结果表明，iNO组与安慰剂组相比，平均±标准差的总肺容量（TLC，5.54±1.42 vs. 4.81±1.00；P = 0.026）绝对值显著更好。以下各项平均±标准差的预测值百分比也有显著更好的值：a）1秒用力呼气量（FEV1，80.23±21.21 vs. 69.51±28.97；P = 0.042），b）用力肺活量（FVC，83.78±19.37 vs. 69.84±27.40；P = 0.019），c）FEV1/FVC（96.14±13.79 vs. 87.92±19.77；P = 0.033），以及d）TLC（93.33±18.21 vs. 76.10±21.84；P < 0.001）。在FEV1绝对值、FEV1/FVC、FVC、FVC 25%至75%的用力呼气流量、功能残气量和一氧化碳弥散方面未发现显著差异。
低剂量iNO治疗后存活的ARDS患者在治疗后6个月的某些肺功能测试值显著优于接受安慰剂治疗的患者。有必要进行进一步试验以确定iNO对ARDS幸存者慢性肺功能的影响，这是该人群长期发病率和生活质量的一个因素。
吸入一氧化氮治疗急性呼吸窘迫综合征的双盲、随机安慰剂对照剂量反应研究。NCT编号：ISRCTN53268296。
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