Roomi Sohaib, Ullah Waqas, Ahmed Faizan, Farooq Soban, Sadiq Usama, Chohan Asad, Jafar Munnam, Saddique Maryum, Khanal Shristi, Watson Robert, Boigon Margot
Jefferson Health Abington, Abington, PA, United States.
King Edward Medical University, Lahore, Pakistan.
J Med Internet Res. 2020 Sep 1;22(9):e21758. doi: 10.2196/21758.
During the initial phases of the COVID-19 pandemic, there was an unfounded fervor surrounding the use of hydroxychloroquine (HCQ) and tocilizumab (TCZ); however, evidence on their efficacy and safety have been controversial.
The purpose of this study is to evaluate the overall clinical effectiveness of HCQ and TCZ in patients with COVID-19. We hypothesize that HCQ and TCZ use in these patients will be associated with a reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis.
A retrospective cohort study was performed to determine the impact of HCQ and TCZ use on hard clinical outcomes during hospitalization. A total of 176 hospitalized patients with a confirmed COVID-19 diagnosis was included. Patients were divided into two comparison groups: (1) HCQ (n=144) vs no-HCQ (n=32) and (2) TCZ (n=32) vs no-TCZ (n=144). The mean age, baseline comorbidities, and other medications used during hospitalization were uniformly distributed among all the groups. Independent t tests and multivariate logistic regression analysis were performed to calculate mean differences and adjusted odds ratios with 95% CIs, respectively.
The unadjusted odds ratio for patients upgraded to a higher level of care (ie, intensive care unit) (OR 2.6, 95% CI 1.19-5.69; P=.003) and reductions in C-reactive protein (CRP) level on day 7 of hospitalization (21% vs 56%, OR 0.21, 95% CI 0.08-0.55; P=.002) were significantly higher in the TCZ group compared to the control group. There was no significant difference in the odds of in-hospital mortality, upgrade to intensive medical care, need for invasive mechanical ventilation, acute kidney failure necessitating dialysis, or discharge from the hospital after recovery in both the HCQ and TCZ groups compared to their respective control groups. Adjusted odds ratios controlled for baseline comorbidities and medications closely followed the unadjusted estimates.
In this cohort of patients with COVID-19, neither HCQ nor TCZ offered a significant reduction in in-hospital mortality, upgrade to intensive medical care, invasive mechanical ventilation, or acute renal failure needing dialysis. These results are similar to the recently published preliminary results of the HCQ arm of the Recovery trial, which showed no clinical benefit from the use of HCQ in hospitalized patients with COVID-19 (the TCZ arm is ongoing). Double-blinded randomized controlled trials are needed to further evaluate the impact of these drugs in larger patient samples so that data-driven guidelines can be deduced to combat this global pandemic.
在新型冠状病毒肺炎(COVID-19)大流行的初始阶段,围绕羟氯喹(HCQ)和托珠单抗(TCZ)的使用出现了毫无根据的狂热;然而,关于它们疗效和安全性的证据一直存在争议。
本研究的目的是评估HCQ和TCZ对COVID-19患者的总体临床疗效。我们假设在这些患者中使用HCQ和TCZ将与住院死亡率降低、升级到重症监护、有创机械通气或需要透析的急性肾衰竭减少相关。
进行了一项回顾性队列研究,以确定使用HCQ和TCZ对住院期间严重临床结局的影响。总共纳入了176例确诊为COVID-19的住院患者。患者分为两个比较组:(1)HCQ组(n = 144)与非HCQ组(n = 32),以及(2)TCZ组(n = 32)与非TCZ组(n = 144)。所有组的平均年龄、基线合并症以及住院期间使用的其他药物分布均匀。分别进行独立t检验和多因素逻辑回归分析,以计算平均差异和校正比值比及95%置信区间。
与对照组相比,TCZ组中升级到更高护理水平(即重症监护病房)的患者的未校正比值比(OR 2.6,95% CI 1.19 - 5.69;P = 0.003)以及住院第7天C反应蛋白(CRP)水平的降低(21%对56%,OR 0.21,95% CI 0.08 - 0.55;P = 0.002)显著更高。与各自对照组相比,HCQ组和TCZ组在住院死亡率、升级到重症监护、有创机械通气需求、需要透析的急性肾衰竭或康复后出院的几率方面均无显著差异。校正了基线合并症和药物的校正比值比与未校正估计值密切相关。
在这组COVID-19患者中,HCQ和TCZ均未显著降低住院死亡率、升级到重症监护、有创机械通气或需要透析的急性肾衰竭。这些结果与最近发表的RECOVERY试验中HCQ组的初步结果相似,该结果显示在住院COVID-19患者中使用HCQ没有临床益处(TCZ组试验正在进行)。需要进行双盲随机对照试验,以在更大的患者样本中进一步评估这些药物的影响,从而推导出以数据为驱动的指南来应对这一全球大流行。