Neuromuscular Blockers in Early Acute Respiratory Distress Syndrome.
Neuromuscular Blockers in Early Acute Respiratory Distress Syndrome.
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DOI：
10.1056/nejmoa1005372
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发表时间：
2010-09-16
影响因子：
158.5
通讯作者：
Roch, Antoine
中科院分区：
文献类型：
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作者：
Papazian, Laurent;Forel, Jean-Marie;Roch, Antoine
背景：在接受机械通气治疗急性呼吸窘迫综合征（ARDS）的患者中，神经肌肉阻断剂可以改善氧合并减少呼吸机引起的肺损伤，但也可能导致肌肉无力。我们评估了早期严重ARDS患者接受神经肌肉阻滞剂治疗2天后的临床结果。方法：在这项多中心双盲试验中，340例在48小时内出现严重急性呼吸窘迫综合征（ARDS）的重症监护病房（ICU）患者被随机分配接受顺阿曲库铵（178例）或安慰剂（162例）治疗48小时。重度ARDS定义为动脉氧分压（PaO(sub - 2)）与吸入氧分压（FIO(sub - 2)）之比小于150，呼气末正压为5cm或更高，潮气量为每千克预测体重6至8ml。主要结局是患者在出院前或研究入组后90天内死亡的比例（即90天住院死亡率），并使用Cox模型对预定义协变量和组间基线差异进行调整。结果：在调整基线PaO（亚2）：FIO（亚2）、平台压力和简化急性生理II评分后，顺阿曲库ium组90天死亡的风险比与安慰剂组相比为0.68（95%可信区间[CI]， 0.48至0.98；P=0.04）。顺阿曲库铵组90天粗死亡率为31.6% (95% CI, 25.2 ~ 38.8)，安慰剂组为40.7% (95% CI, 33.5 ~ 48.4) （P=0.08）。顺阿曲库铵组28天死亡率为23.7% (95% CI, 18.1 ~ 30.5)，安慰剂组为33.3% (95% CI, 26.5 ~ 40.9) （P=0.05）。两组间icu获得性脑轻瘫发生率无显著差异。结论：在严重急性呼吸窘迫综合征患者中，早期给予神经肌肉阻滞剂可提高调整后的90天生存率，并在不增加肌肉无力的情况下增加脱离呼吸机的时间。（由马赛公共医院援助和法国卫生部2004-26年地区临床研究医院方案资助；ClinicalTrials.gov编号：NCT00299650。）中华医学杂志（英文版）；2010;31(3):1107- 1106。
Background: In patients undergoing mechanical ventilation for the acute respiratory distress syndrome (ARDS), neuromuscular blocking agents may improve oxygenation and decrease ventilator-induced lung injury but may also cause muscle weakness. We evaluated clinical outcomes after 2 days of therapy with neuromuscular blocking agents in patients with early, severe ARDS.Methods: In this multicenter, double-blind trial, 340 patients presenting to the intensive care unit (ICU) with an onset of severe ARDS within the previous 48 hours were randomly assigned to receive, for 48 hours, either cisatracurium besylate (178 patients) or placebo (162 patients). Severe ARDS was defined as a ratio of the partial pressure of arterial oxygen (PaO(sub 2)) to the fraction of inspired oxygen (FIO(sub 2)) of less than 150, with a positive end-expiratory pressure of 5 cm or more of water and a tidal volume of 6 to 8 ml per kilogram of predicted body weight. The primary outcome was the proportion of patients who died either before hospital discharge or within 90 days after study enrollment (i.e., the 90-day in-hospital mortality rate), adjusted for predefined covariates and baseline differences between groups with the use of a Cox model.Results: The hazard ratio for death at 90 days in the cisatracurium group, as compared with the placebo group, was 0.68 (95% confidence interval [CI], 0.48 to 0.98; P=0.04), after adjustment for both the baseline PaO(sub 2):FIO(sub 2) and plateau pressure and the Simplified Acute Physiology II score. The crude 90-day mortality was 31.6% (95% CI, 25.2 to 38.8) in the cisatracurium group and 40.7% (95% CI, 33.5 to 48.4) in the placebo group (P=0.08). Mortality at 28 days was 23.7% (95% CI, 18.1 to 30.5) with cisatracurium and 33.3% (95% CI, 26.5 to 40.9) with placebo (P=0.05). The rate of ICU-acquired paresis did not differ significantly between the two groups.Conclusions: In patients with severe ARDS, early administration of a neuromuscular blocking agent improved the adjusted 90-day survival and increased the time off the ventilator without increasing muscle weakness. (Funded by Assistance Publique-Hopitaux de Marseille and the Programme Hospitalier de Recherche Clinique Regional 2004-26 of the French Ministry of Health; ClinicalTrials.gov number, NCT00299650.)N Engl J Med 2010;363:1107-16.