Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada; Department of Surgery, McMaster University, Hamilton, ON, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.
Lancet. 2015 Sep 26;386(10000):1243-1253. doi: 10.1016/S0140-6736(15)00273-1.
Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass.
The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388.
Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared with placebo, did not reduce the risk of death at 30 days (154 [4%] vs 177 [5%] patients; relative risk [RR] 0·87, 95% CI 0·70-1·07, p=0·19) or the risk of death or major morbidity (909 [24%] vs 885 [24%]; RR 1·03, 95% CI 0·95-1·11, p=0·52). The most common safety outcomes in the methylprednisolone and placebo group were infection (465 [12%] vs 493 [13%]), surgical site infection (151 [4%] vs 151 [4%]), and delirium (295 [8%] vs 289 [8%]).
Methylprednisolone did not have a significant effect on mortality or major morbidity after cardiac surgery with cardiopulmonary bypass. The SIRS trial does not support the routine use of methylprednisolone for patients undergoing cardiopulmonary bypass.
Canadian Institutes of Health Research.
体外循环会引发全身性炎症反应综合征，这与术后发病率和死亡率有关。类固醇可以抑制炎症反应，并可能改善高危发病率和死亡率的体外循环患者的预后。我们旨在评估类固醇对高危发病率和死亡率的体外循环患者的影响。
类固醇在心脏手术中的作用（SIRS）研究是一项双盲、随机、对照试验。我们使用中央计算机电话或交互式网络系统随机分配（1:1）来自 18 个国家的 80 家医院或心脏手术中心的高危发病率和死亡率患者，这些患者在使用体外循环的心脏手术中接受甲基强的松龙（麻醉诱导时 250mg，体外循环开始时 250mg）或安慰剂。患者采用块随机化，块大小为 2、4 或 6，并按中心分层。年龄在 18 岁或以上、欧洲心脏手术风险评估系统至少为 6 分的患者有资格参加。如果患者在术后立即接受或预计接受全身类固醇治疗，或在过去 30 天内有细菌或真菌感染史，则将其排除在外。患者、护理人员和评估结果的人员对分配情况不知情。主要结局是 30 天死亡率和 30 天内死亡和主要发病率（即心肌损伤、中风、肾衰竭或呼吸衰竭）的复合结局，均通过意向治疗进行分析。安全性结局也通过意向治疗进行分析。这项研究在 ClinicalTrials.gov 注册，编号为 NCT00427388。
患者于 2007 年 6 月 21 日至 2013 年 12 月 19 日期间入组。随机分配至甲基强的松龙（n=3755）和安慰剂（n=3752）的 7507 名患者均获得了完整的 30 天数据。与安慰剂相比，甲基强的松龙并未降低 30 天的死亡率（154[4%]例患者 vs 177[5%]例患者；相对风险[RR]0.87，95%CI0.70-1.07，p=0.19）或死亡或主要发病率（909[24%]例患者 vs 885[24%]例患者；RR1.03，95%CI0.95-1.11，p=0.52）的风险。甲基强的松龙组和安慰剂组最常见的安全性结局是感染（465[12%]例患者 vs 493[13%]例患者）、手术部位感染（151[4%]例患者 vs 151[4%]例患者）和谵妄（295[8%]例患者 vs 289[8%]例患者）。
体外循环心脏手术后，甲基强的松龙对死亡率或主要发病率没有显著影响。SIRS 试验不支持常规使用甲基强的松龙治疗体外循环患者。
加拿大卫生研究院。
