地塞米松在心脏手术中的应用：一项实践偏好-随机同意的比较有效性试验。

Dexamethasone for Cardiac Surgery: A Practice Preference-Randomized Consent Comparative Effectiveness Trial.

机构信息

Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia.

Department of Anaesthesia, Westmead Hospital, Western Sydney University, Penrith, Australia.

出版信息

Anesthesiology. 2024 Nov 1;141(5):859-869. doi: 10.1097/ALN.0000000000005127.

DOI:10.1097/ALN.0000000000005127

PMID:38904693

Abstract

BACKGROUND

High-dose corticosteroids have been used to attenuate the inflammatory response to cardiac surgery and cardiopulmonary bypass, but patient outcome benefits remain unclear. The primary aim was to determine whether using dexamethasone was superior to not using dexamethasone to increase the number of home days in the first 30 days after cardiac surgery. The secondary aim was to evaluate efficiency, value, and impact of the novel trial design.

METHODS

This pragmatic, international trial incorporating a prerandomized consent design favoring local practice enrolled patients undergoing cardiac surgery across seven hospitals in Australia and The Netherlands. Patients were randomly assigned to dexamethasone 1 mg/kg or not (control). The primary outcome was the number of days alive and at home up to 30 days after surgery ("home days"). Secondary outcomes included prolonged mechanical ventilation (more than 48 h), sepsis, renal failure, myocardial infarction, stroke, and death.

RESULTS

Of 2,562 patients assessed for eligibility, 1,951 were randomized (median age, 63 yr; 80% male). The median number of home days was 23.0 (interquartile range, 20.1 to 24.1) in the no dexamethasone group and 23.1 (interquartile range, 20.1 to 24.6) in the dexamethasone group (median difference, 0.1; 95% CI, -0.3 to 0.5; P = 0.66). The rates of prolonged mechanical ventilation (risk ratio, 0.72; 95% CI, 0.48 to 1.08), sepsis (risk ratio, 1.02; 95% CI, 0.57 to 1.82), renal failure (risk ratio, 0.94; 95% CI, 0.80 to 1.12), myocardial infarction (risk ratio, 1.20; 95% CI, 0.30 to 4.82), stroke (risk ratio, 1.06; 95% CI, 0.54 to 2.08), and death (risk ratio, 0.72; 95% CI, 0.22 to 2.35) were comparable between groups (all P > 0.10). Dexamethasone reduced intensive care unit stay (median, 29 h; interquartile range, 22 to 50 h vs. median, 43 h; interquartile range, 24 to 72 h; P = 0.004). The authors' novel trial design was highly efficient (89.3% enrollment).

CONCLUSIONS

Among patients undergoing cardiac surgery, high-dose dexamethasone decreased intensive care unit stay but did not increase the number of home days after surgery.

摘要

背景

大剂量皮质类固醇已被用于减轻心脏手术和体外循环引起的炎症反应，但患者的预后获益仍不清楚。主要目的是确定使用地塞米松是否优于不使用地塞米松来增加心脏手术后 30 天内的在家天数。次要目的是评估新型试验设计的效率、价值和影响。

方法

本项务实的国际试验采用了有利于当地实践的预先随机化同意设计，纳入了澳大利亚和荷兰 7 家医院的心脏手术患者。患者被随机分配至地塞米松 1mg/kg 组或不使用地塞米松（对照组）。主要结局是术后 30 天内的生存和在家天数（“在家天数”）。次要结局包括延长机械通气（超过 48 小时）、脓毒症、肾功能衰竭、心肌梗死、中风和死亡。

结果

在评估的 2562 名符合条件的患者中，1951 名患者被随机分组（中位年龄 63 岁；80%为男性）。地塞米松组的中位在家天数为 23.0 天（四分位距，20.1 至 24.1），对照组为 23.1 天（四分位距，20.1 至 24.6）（中位数差异 0.1；95%CI，-0.3 至 0.5；P=0.66）。机械通气延长（风险比，0.72；95%CI，0.48 至 1.08）、脓毒症（风险比，1.02；95%CI，0.57 至 1.82）、肾功能衰竭（风险比，0.94；95%CI，0.80 至 1.12）、心肌梗死（风险比，1.20；95%CI，0.30 至 4.82）、中风（风险比，1.06；95%CI，0.54 至 2.08）和死亡（风险比，0.72；95%CI，0.22 至 2.35）的发生率在两组之间无差异（均 P＞0.10）。地塞米松组 ICU 住院时间（中位数 29 小时；四分位距 22 至 50 小时）短于对照组（中位数 43 小时；四分位距 24 至 72 小时；P=0.004）。作者的新型试验设计非常高效（89.3%的入组率）。