瑞舒伐他汀对比安慰剂治疗脓毒症相关急性呼吸窘迫综合征的一年结局：SAILS随机试验的前瞻性随访
One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: prospective follow-up of SAILS randomised trial.
作者信息
Dinglas Victor D, Hopkins Ramona O, Wozniak Amy W, Hough Catherine L, Morris Peter E, Jackson James C, Mendez-Tellez Pedro A, Bienvenu O Joseph, Ely E Wesley, Colantuoni Elizabeth, Needham Dale M
机构信息
Outcomes after Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, USA Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Pulmonary and Critical Care Division, Department of Medicine, Intermountain Medical Center, Murray, Utah, USA Psychology Department and Neuroscience Center, Brigham Young University, Provo, Utah, USA Center for Humanizing Critical Care, Intermountain Health Care, Murray, Utah, USA.
出版信息
Thorax. 2016 May;71(5):401-10. doi: 10.1136/thoraxjnl-2015-208017. Epub 2016 Mar 2.
BACKGROUND
Prior randomised trials have evaluated statins in patients with sepsis and acute respiratory distress syndrome (ARDS), but there has been no comprehensive evaluation of long-term effects, despite potential neuromuscular and mental health adverse effects of these drugs.
AIM
To evaluate the effect of rosuvastatin versus placebo on survival, physical function and performance, and mental health outcomes in patients with sepsis-associated ARDS.
METHODS
Prospective follow-up evaluation of the ARDS Clinical Trials Network Statins for Acutely Injured Lungs from Sepsis trial of rosuvastatin versus placebo in 568 mechanically ventilated patients with sepsis-associated ARDS, with blinded 6-month outcome assessment performed in the 272 eligible survivors for age-adjusted and sex-adjusted 36-Item Short Form Health Survey (SF-36) physical function and mental health domains, and in 84 eligible survivors for the 6 min walk test, along with secondary outcomes evaluations of survival, and additional patient-reported and performance-based measures at 6-month and 12-month follow-up.
RESULTS
Over 1-year follow-up, there was no significant difference in cumulative survival in the rosuvastatin versus placebo groups (58% vs 61%; p=0.377), with survivors demonstrating substantial impairments in physical function and mental health. Rosuvastatin versus placebo had no effect (mean treatment effect (95% CI)) on SF-36 physical function (0 (-7 to 8), p=0.939) or mental health (-6 (-12 to 1) p=0.085) domains, 6 min walk distance (per cent predicted: 2 (-9 to 14), p=0.679) or the vast majority of secondary outcomes.
CONCLUSIONS
Over 1-year follow-up, patients with sepsis-associated ARDS had high cumulative mortality, with survivors commonly experiencing impairments in physical functioning and performance, and mental health. Randomisation to rosuvastatin had no effect on these outcomes.
TRIAL REGISTRATION NUMBER
NCT00979121 and NCT00719446.
背景
既往随机试验对脓毒症和急性呼吸窘迫综合征（ARDS）患者使用他汀类药物进行了评估，但尽管这些药物存在潜在的神经肌肉和心理健康不良影响，却尚未对其长期影响进行全面评估。
目的
评估瑞舒伐他汀与安慰剂对脓毒症相关性ARDS患者生存、身体功能与表现以及心理健康结局的影响。
方法
对ARDS临床试验网络开展的脓毒症致急性肺损伤使用他汀类药物试验进行前瞻性随访评估，该试验比较了瑞舒伐他汀与安慰剂对568例接受机械通气的脓毒症相关性ARDS患者的疗效，对272例符合条件的幸存者进行了6个月结局评估，评估内容包括年龄和性别校正后的36项简明健康调查问卷（SF-36）身体功能和心理健康领域，对84例符合条件的幸存者进行6分钟步行试验，同时在6个月和12个月随访时对生存以及其他患者报告和基于表现的指标进行次要结局评估。
结果
在超过1年的随访中，瑞舒伐他汀组与安慰剂组的累积生存率无显著差异（58%对61%；p=0.377），幸存者在身体功能和心理健康方面存在严重损害。瑞舒伐他汀与安慰剂对SF-36身体功能（0（-7至8），p=0.939）或心理健康（-6（-12至1），p=0.085）领域、6分钟步行距离（预测百分比：2（-9至14），p=0.679）或绝大多数次要结局均无影响。
结论
在超过1年的随访中，脓毒症相关性ARDS患者累积死亡率较高，幸存者通常在身体功能与表现以及心理健康方面存在损害。随机分配至瑞舒伐他汀组对这些结局无影响。
试验注册号
NCT00979121和NCT00719446。
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