Glucocorticoids with low-dose anti-IL1 anakinra rescue in severe non-ICU COVID-19 infection: A cohort study.
Glucocorticoids with low-dose anti-IL1 anakinra rescue in severe non-ICU COVID-19 infection: A cohort study.
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在严重的非ICU COVID-19感染中，具有低剂量抗IL1 Anakinra救援的糖皮质激素：一项队列研究。
DOI：
10.1371/journal.pone.0243961
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发表时间：
2020
期刊：
影响因子：
3.7
通讯作者：
Bichat & Kremlin-Bicêtre AP-HP COVID teams
中科院分区：
文献类型：
--
作者：
Borie R;Savale L;Dossier A;Ghosn J;Taillé C;Visseaux B;Jebreen K;Diallo A;Tesmoingt C;Morer L;Goletto T;Faucher N;Hajouji L;Neukirch C;Phillips M;Stelianides S;Bouadma L;Brosseau S;Ottaviani S;Pluvy J;Le Pluart D;Debray MP;Raynaud-Simon A;Descamps D;Khalil A;Timsit JF;Lescure FX;Descamps V;Papo T;Humbert M;Crestani B;Dieude P;Vicaut E;Zalcman G;Bichat & Kremlin-Bicêtre AP-HP COVID teams
对于患有严重冠状病毒-19疾病（COVID-19）和高度炎症的患者的最佳治疗方法仍存在争议。设计了一项队列研究，以评估使用类固醇联合或不联合白细胞介素-1拮抗剂（阿那白滞素）的治疗方案是否可以预防死亡/有创通气。自症状出现以来病情发展≥5天、炎症过度（CRP≥ 50 mg/L）、需要3-5 L/min氧气的患者单独接受甲泼尼龙治疗。需要≥6 L/min的患者每日接受甲泼尼龙+皮下阿那白滞素治疗，一线治疗或单独使用皮质类固醇治疗临床恶化。根据logistic回归和倾向评分确定第15天的死亡率和死亡或重症监护室（ICU）有创通气率，以及比值比（OR）和95% CI。贝叶斯分析估计了治疗效果。在108例连续患者中，70例患者仅接受糖皮质激素治疗。对照组包括63名接受标准治疗的患者。在皮质类固醇±斯那白滞素组（n = 108）中，死亡率为20.4%，对照组为30.2%，表明死亡风险相对降低30%，10例患者接受治疗以避免死亡（p = 0.15）。使用倾向评分，符合方案分析显示COVID-19相关死亡的OR为0.9（95%CI [0.80-1.01]，p = 0.067）。在贝叶斯分析中，皮质类固醇+/-阿那白滞素的任何死亡率获益的后验概率为87.5%，治疗相关损害的概率为7.8%。108例患者中有29例（26.9%）发生了既存糖尿病加重。在细胞因子释放期的COVID-19非ICU住院患者中，皮质类固醇联合或不联合阿那白滞素与第15天死亡风险降低30%相关。
The optimal treatment for patients with severe coronavirus-19 disease (COVID-19) and hyper-inflammation remains debated. A cohort study was designed to evaluate whether a therapeutic algorithm using steroids with or without interleukin-1 antagonist (anakinra) could prevent death/invasive ventilation. Patients with a ≥5-day evolution since symptoms onset, with hyper-inflammation (CRP≥50mg/L), requiring 3–5 L/min oxygen, received methylprednisolone alone. Patients needing ≥6 L/min received methylprednisolone + subcutaneous anakinra daily either frontline or in case clinical deterioration upon corticosteroids alone. Death rate and death or intensive care unit (ICU) invasive ventilation rate at Day 15, with Odds Ratio (OR) and 95% CIs, were determined according to logistic regression and propensity scores. A Bayesian analysis estimated the treatment effects. Of 108 consecutive patients, 70 patients received glucocorticoids alone. The control group comprised 63 patients receiving standard of care. In the corticosteroid±stanakinra group (n = 108), death rate was 20.4%, versus 30.2% in the controls, indicating a 30% relative decrease in death risk and a number of 10 patients to treat to avoid a death (p = 0.15). Using propensity scores a per-protocol analysis showed an OR for COVID-19-related death of 0.9 (95%CI [0.80–1.01], p = 0.067). On Bayesian analysis, the posterior probability of any mortality benefit with corticosteroids+/-anakinra was 87.5%, with a 7.8% probability of treatment-related harm. Pre-existing diabetes exacerbation occurred in 29 of 108 patients (26.9%). In COVID-19 non-ICU inpatients at the cytokine release phase, corticosteroids with or without anakinra were associated with a 30% decrease of death risk on Day 15.
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