Anakinra combined with methylprednisolone in patients with severe COVID-19 pneumonia and hyperinflammation: An observational cohort study.
Anakinra combined with methylprednisolone in patients with severe COVID-19 pneumonia and hyperinflammation: An observational cohort study.
复制标题
DOI：
10.1016/j.jaci.2020.11.006
复制
发表时间：
2021-03
期刊：
影响因子：
--
通讯作者：
Bandera A
中科院分区：
文献类型：
--
作者：
Bozzi G;Mangioni D;Minoia F;Aliberti S;Grasselli G;Barbetta L;Castelli V;Palomba E;Alagna L;Lombardi A;Ungaro R;Agostoni C;Baldini M;Blasi F;Cesari M;Costantino G;Fracanzani AL;Montano N;Monzani V;Pesenti A;Peyvandi F;Sottocorno M;Muscatello A;Filocamo G;Gori A;Bandera A
免疫调节剂已被提议用于减轻严重急性呼吸综合征冠状病毒2诱导的细胞因子风暴，该风暴导致2019冠状病毒病（COVID-19）中的急性呼吸窘迫综合征。我们试图确定IL-1受体拮抗剂阿那白滞素联合甲泼尼龙治疗重度COVID-19肺炎伴炎症过度的有效性和安全性。在意大利三级医疗机构进行了前瞻性观察性队列研究的二次分析。对连续住院（2020年2月25日至2020年3月30日）的患有炎症过度（铁蛋白≥1000 ng/mL和/或C反应蛋白>10 mg/dL）和呼吸衰竭（从0.4 FiO 2文丘里面罩到有创机械通气的氧疗）的COVID-19患者进行了评估，以研究大剂量阿那白滞素联合甲基强的松龙对生存的影响。从研究入选至第28天或死亡，对患者进行随访。计算粗风险和校正风险（性别、年龄、基线PaO 2：FiO 2比值、Charlson指数、基线机械通气、住院至入选失效）（考克斯比例回归模型）。共评估了120名患有炎症过度的COVID-19患者（中位年龄为62岁; 80.0%为男性;中位PaO 2：FiO 2比值为151; 32.5%接受机械通气）。其中，65例接受阿那白滞素和甲基强的松龙治疗，55例为未治疗的历史对照。28天时，治疗组患者的死亡率为13.9%，对照组为35.6%（Kaplan-Meier图，P = 0.005）。与对照组相比，治疗组患者的未校正和校正死亡风险显著降低（风险比分别为0.33，95% CI，0.15-0.74，P = 0.007和HR，0.18，95% CI，0.07-0.50，P = 0.001）。血流感染或实验室改变无显著差异。阿那白滞素联合甲泼尼龙治疗可能是COVID-19患者炎症过度和呼吸衰竭以及机械通气的有效治疗选择。需要随机对照试验（包括单独使用任何一种药物）来证实这些结果。
Immunomodulants have been proposed to mitigate severe acute respiratory syndrome coronavirus 2–induced cytokine storm, which drives acute respiratory distress syndrome in coronavirus disease 2019 (COVID-19). We sought to determine efficacy and safety of the association of IL-1 receptor antagonist anakinra plus methylprednisolone in severe COVID-19 pneumonia with hyperinflammation. A secondary analysis of prospective observational cohort studies was carried out at an Italian tertiary health care facility. COVID-19 patients consecutively hospitalized (February 25, 2020, to March 30, 2020) with hyperinflammation (ferritin ≥1000 ng/mL and/or C-reactive protein >10 mg/dL) and respiratory failure (oxygen therapy from 0.4 FiO2 Venturi mask to invasive mechanical ventilation) were evaluated to investigate the effect of high-dose anakinra plus methylprednisolone on survival. Patients were followed from study inclusion to day 28 or death. Crude and adjusted (sex, age, baseline PaO2:FiO2 ratio, Charlson index, baseline mechanical ventilation, hospitalization to inclusion lapse) risks were calculated (Cox proportional regression model). A total of 120 COVID-19 patients with hyperinflammation (median age, 62 years; 80.0% males; median PaO2:FiO2 ratio, 151; 32.5% on mechanical ventilation) were evaluated. Of these, 65 were treated with anakinra and methylprednisolone and 55 were untreated historical controls. At 28 days, mortality was 13.9% in treated patients and 35.6% in controls (Kaplan-Meier plots, P = .005). Unadjusted and adjusted risk of death was significantly lower for treated patients compared with controls (hazard ratio, 0.33, 95% CI, 0.15-0.74, P = .007, and HR, 0.18, 95% CI, 0.07-0.50, P = .001, respectively). No significant differences in bloodstream infections or laboratory alterations were registered. Treatment with anakinra plus methylprednisolone may be a valid therapeutic option in COVID-19 patients with hyperinflammation and respiratory failure, also on mechanical ventilation. Randomized controlled trials including the use of either agent alone are needed to confirm these results.
登录
查看更多内容
影响因子：
11.8
作者：
Qin, Chuan;Zhou, Luoqi;Tian, Dai-Shi
通讯作者：
Tian, Dai-Shi
影响因子：
11.8
作者：
Fadel, Raef;Morrison, Austin R.;Ramesh, Mayur S.
通讯作者：
Ramesh, Mayur S.
影响因子：
27.4
作者：
Ramiro, Sofia;Mostard, Remy L. M.;Landewe, Robert B. M.
通讯作者：
Landewe, Robert B. M.
影响因子：
15.9
作者：
Chen, Guang;Wu, Di;Ning, Qin
通讯作者：
Ning, Qin
影响因子：
120.7
作者：
Sterne, Jonathan A. C.;Murthy, Srinivas;Marshall, John C.
通讯作者：
Marshall, John C.