Jonmarker Sandra, Alarcón Felix, Litorell Jacob, Granholm Anders, Alm Eva Joelsson, Chew Michelle, Russell Lene, Weihe Sarah, Madsen Emilie Kabel, Meier Nick, Leistner Jens Wolfgang, Mårtensson Johan, Hollenberg Jacob, Perner Anders, Kjær Maj-Brit Nørregaard, Munch Marie Warrer, Dahlberg Martin, Cronhjort Maria, Wahlin Rebecka Rubenson
Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.
Department of Anaesthesia and Intensive Care, Södersjukhuset, Sjukhusbacken 10, SE-118 83, Stockholm, Sweden.
Ann Intensive Care. 2023 Mar 2;13(1):12. doi: 10.1186/s13613-023-01115-y.
Thromboembolism is more common in patients with critical COVID-19 than in other critically ill patients, and inflammation has been proposed as a possible mechanism. The aim of this study was to investigate if 12 mg vs. 6 mg dexamethasone daily reduced the composite outcome of death or thromboembolism in patients with critical COVID-19.
Using additional data on thromboembolism and bleeding we did a post hoc analysis of Swedish and Danish intensive care unit patients enrolled in the blinded randomized COVID STEROID 2 trial comparing 12 mg vs. 6 mg dexamethasone daily for up to 10 days. The primary outcome was a composite outcome of death or thromboembolism during intensive care. Secondary outcomes were thromboembolism, major bleeding, and any bleeding during intensive care.
We included 357 patients. Whilst in intensive care, 53 patients (29%) in the 12 mg group and 53 patients (30%) in the 6 mg group met the primary outcome with an unadjusted absolute risk difference of - 0.5% (95% CI - 10 to 9.5%, p = 1.00) and an adjusted OR of 0.93 (CI 95% 0.58 to 1.49, p = 0.77). We found no firm evidence of differences in any of the secondary outcomes.
Among patients with critical COVID-19, 12 mg vs. 6 mg dexamethasone daily did not result in a statistically significant difference in the composite outcome of death or thromboembolism. However, uncertainty remains due to the limited number of patients.
与其他危重症患者相比，血栓栓塞在重症新型冠状病毒肺炎（COVID-19）患者中更为常见，炎症被认为是一种可能的机制。本研究的目的是调查每日给予12毫克与6毫克地塞米松是否能降低重症COVID-19患者死亡或血栓栓塞的复合结局。
利用关于血栓栓塞和出血的额外数据，我们对瑞典和丹麦重症监护病房参与双盲随机COVID STEROID 2试验的患者进行了事后分析，该试验比较了每日给予12毫克与6毫克地塞米松，持续10天。主要结局是重症监护期间死亡或血栓栓塞的复合结局。次要结局是重症监护期间的血栓栓塞、大出血和任何出血情况。
我们纳入了357例患者。在重症监护期间，12毫克组有53例患者（29%），6毫克组有53例患者（30%）达到主要结局，未调整的绝对风险差异为-0.5%（95%CI -10至9.5%，p = 1.00），调整后的OR为0.93（95%CI 0.58至1.49，p = 0.77）。我们没有发现任何次要结局存在差异的确切证据。
在重症COVID-19患者中，每日给予12毫克与6毫克地塞米松在死亡或血栓栓塞的复合结局方面没有统计学上的显著差异。然而，由于患者数量有限，不确定性仍然存在。
