Convalescent plasma associates with reduced mortality and improved clinical trajectory in patients hospitalized with COVID-19
Convalescent plasma associates with reduced mortality and improved clinical trajectory in patients hospitalized with COVID-19
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DOI：
10.1172/jci151788
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发表时间：
2021-10-15
影响因子：
15.9
通讯作者：
LeMaistre, Charles F.
中科院分区：
文献类型：
--
作者：
Egloff, Shanna A. Arnold;Junglen, Angela;LeMaistre, Charles F.
背景。康复期血浆（CP）是治疗2019冠状病毒病（COVID-19）的首批研究性治疗方法之一，但支持它的证据尚无定论，导致各种建议相互矛盾。主要目的是开展CP对COVID-19患者全因住院死亡率的比较有效性研究。方法。这项基于电子健康记录的多中心回顾性研究包括在176家HCA医疗保健附属社区医院之一的44,770名因COVID-19住院的患者。采用粗化精确匹配（1:k），得到3774例CP和10687例对照患者的样本。结果。使用共同虚弱模型检查死亡率，控制伴随用药、入院日期和入院至输血天数，显示CP与相对于对照组的较低死亡风险显著相关（校正风险比[aHR] = 0.71; 95% CI, 0.59-0.86; P < 0.001）。通过对实时风险模型（RTRM）中400个临床人口学特征所代表的患者风险轨迹的检查表明，接受CP治疗的患者恢复得更快。输血天数的分层显示，入院后3天内的CP与较低的死亡风险相关（aHR = 0.53; 95% CI, 0.47-0.60; P < 0.001），而4 - 7天内的CP与较低的死亡风险无关。在控制血清学水平与输血天数的相互作用后，其与死亡率呈负相关（HR = 0.998; 95% CI, 0.997-0.999; P = 0.013），但未达到单变量显著性。结论。这项大型、多样化、多中心队列研究表明，与匹配对照相比，CP与降低住院死亡率风险显著相关。这些观察结果突出了现实世界证据的实用性，并表明在放弃CP作为COVID-19的可行治疗方法之前，需要进一步评估。
BACKGROUND. Evidence supporting convalescent plasma (CP), one of the first investigational treatments for coronavirus disease 2019 (COVID-19), has been inconclusive, leading to conflicting recommendations. The primary objective was to perform a comparative effectiveness study of CP for all-cause, in-hospital mortality in patients with COVID-19. METHODS. The multicenter, electronic health records-based, retrospective study included 44,770 patients hospitalized with COVID-19 in one of 176 HCA Healthcare-affiliated community hospitals. Coarsened exact matching (1:k) was employed, resulting in a sample of 3774 CP and 10,687 comparison patients. RESULTS. Examination of mortality using a shared frailty model, controlling for concomitant medications, date of admission, and days from admission to transfusion, demonstrated a significant association of CP with lower mortality risk relative to the comparison group (adjusted hazard ratio [aHR] = 0.71; 95% CI, 0.59-0.86; P < 0.001). Examination of patient risk trajectories, represented by 400 clinico-demographic features from our real-time risk model (RTRM), indicated that patients who received CP recovered more quickly. The stratification of days to transfusion revealed that CP within 3 days after admission, but not within 4 to 7 days, was associated with a significantly lower mortality risk (aHR = 0.53; 95% CI, 0.47-0.60; P < 0.001). CP serology level was inversely associated with mortality when controlling for its interaction with days to transfusion (HR = 0.998; 95% CI, 0.997-0.999; P = 0.013), yet it did not reach univariable significance. CONCLUSIONS. This large, diverse, multicenter cohort study demonstrated that CP, compared with matched controls, is significantly associated with reduced risk of in-hospital mortality. These observations highlight the utility of real-world evidence and suggest the need for further evaluation prior to abandoning CP as a viable therapy for COVID-19.