Alía Inmaculada, de la Cal Miguel A, Esteban Andrés, Abella Ana, Ferrer Ricard, Molina Francisco J, Torres Antoni, Gordo Federico, Elizalde José J, de Pablo Raúl, Huete Alejandro, Anzueto Antonio
Intensive Care Units, Hospital Universitario de Getafe, Centros de Investigacion Biomedica en Red Enfermedades Respiratorias, Getafe, Spain.
Arch Intern Med. 2011 Nov 28;171(21):1939-46. doi: 10.1001/archinternmed.2011.530.
Randomized trials assessing the effect of systemic corticosteroids on chronic obstructive pulmonary disease (COPD) exacerbations excluded patients who were mechanically ventilated or admitted to the intensive care unit (ICU). Critically ill patients constitute a population of persons who are prone to develop complications that are potentially associated with the use of corticosteroids (eg, infections, hyperglycemia, ICU-acquired paresis) that could prolong the duration of mechanical ventilation and even increase mortality.
A double-blind placebo-controlled trial was conducted to evaluate the efficacy and safety of systemic corticosteroid treatment in patients with an exacerbation of COPD who were receiving ventilatory support (invasive or noninvasive mechanical ventilation). A total of 354 adult patients who were admitted to the ICUs of 8 hospitals in 4 countries from July 2005 through July 2009 were screened, and 83 were randomized to receive intravenous methylprednisolone (0.5 mg/kg every 6 hours for 72 hours, 0.5 mg/kg every 12 hours on days 4 through 6, and 0.5 mg/kg/d on days 7 through 10) or placebo. The main outcome measures were duration of mechanical ventilation, length of ICU stay, and need for intubation in patients treated with noninvasive mechanical ventilation.
There were no significant differences between the groups in demographics, severity of illness, reasons for COPD exacerbation, gas exchange variables, and corticosteroid rescue treatment. Corticosteroid treatment was associated with a significant reduction in the median duration of mechanical ventilation (3 days vs 4 days; P = .04), a trend toward a shorter median length of ICU stay (6 days vs 7 days; P = .09), and significant reduction in the rate of NIV failure (0% vs 37%; P = .04).
Systemic corticosteroid therapy in patients with COPD exacerbations requiring mechanical ventilation is associated with a significant increase in the success of noninvasive mechanical ventilation and a reduction in the duration of mechanical ventilation.
clinicaltrials.gov Identifier: NCT01281748.
评估全身用皮质类固醇对慢性阻塞性肺疾病（COPD）加重期影响的随机试验排除了接受机械通气或入住重症监护病房（ICU）的患者。危重症患者人群容易发生可能与使用皮质类固醇相关的并发症（如感染、高血糖、ICU获得性麻痹），这些并发症可能延长机械通气时间，甚至增加死亡率。
进行了一项双盲安慰剂对照试验，以评估全身用皮质类固醇治疗在接受通气支持（有创或无创机械通气）的COPD加重期患者中的疗效和安全性。从2005年7月至2009年7月，对4个国家8家医院ICU收治的354例成年患者进行了筛查，83例患者被随机分组，分别接受静脉注射甲泼尼龙（每6小时0.5mg/kg，共72小时；第4至6天每12小时0.5mg/kg；第7至10天0.5mg/kg/d）或安慰剂治疗。主要结局指标为机械通气时间、ICU住院时间以及接受无创机械通气患者的插管需求。
两组在人口统计学、疾病严重程度、COPD加重原因、气体交换变量和皮质类固醇挽救治疗方面无显著差异。皮质类固醇治疗与机械通气中位时间显著缩短（3天对4天；P = 0.04）、ICU中位住院时间有缩短趋势（6天对7天；P = 0.09）以及无创通气失败率显著降低（0%对37%；P = 0.04）相关。
在需要机械通气的COPD加重期患者中，全身用皮质类固醇治疗与无创机械通气成功率显著提高及机械通气时间缩短相关。
clinicaltrials.gov标识符：NCT01281748。
