Badr Mohamed, De Oliveira Bruno, Abdallah Khaled, Nadeem Ashraf, Varghese Yeldho, Munde Dnyaseshwar, Salam Shameen, Abduljawad Baraa, Saleh Khaled, Elkambergy Hussam, Taha Ahmed, Bayrlee Ahmed, Wahla Ali, Dibu Jamil, Haque Rehan, Hamed Fadi, Rahman Nadeem, Mallat Jihad
Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi 112412, United Arab Emirates.
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH 44195, USA.
J Clin Med. 2021 Feb 14;10(4):760. doi: 10.3390/jcm10040760.
There are limited data regarding the efficacy of methylprednisolone in patients with acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) requiring invasive mechanical ventilation. We aimed to determine whether methylprednisolone is associated with increases in the number of ventilator-free days (VFDs) among these patients. Retrospective single-center study. Intensive care unit. All patients with ARDS due to confirmed SARS-CoV-2 infection and requiring invasive mechanical ventilation between 1 March and 29 May 2020 were included. None. The primary outcome was ventilator-free days (VFDs) for the first 28 days. Defined as being alive and free from mechanical ventilation. The primary outcome was analyzed with competing-risks regression based on Fine and Gray's proportional sub hazards model. Death before day 28 was considered to be the competing event. A total of 77 patients met the inclusion criteria. Thirty-two patients (41.6%) received methylprednisolone. The median dose was 1 mg·kg (IQR: 1-1.3 mg·kg) and median duration for 5 days (IQR: 5-7 days). Patients who received methylprednisolone had a mean 18.8 VFDs (95% CI, 16.6-20.9) during the first 28 days vs. 14.2 VFDs (95% CI, 12.6-16.7) in patients who did not receive methylprednisolone (difference, 4.61, 95% CI, 1.10-8.12, = 0.001). In the multivariable competing-risks regression analysis and after adjusting for potential confounders (ventilator settings, prone position, organ failure support, severity of the disease, tocilizumab, and inflammatory markers), methylprednisolone was independently associated with a higher number of VFDs (subhazards ratio: 0.10, 95% CI: 0.02-0.45, = 0.003). Hospital mortality did not differ between the two groups (31.2% vs. 28.9%, = 0.82). Hospital length of stay was significantly shorter in the methylprednisolone group (24 days [IQR: 15-41 days] vs. 37 days [IQR: 23-52 days], = 0.046). The incidence of positive blood cultures was higher in patients who received methylprednisolone (37.5% vs. 17.8%, = 0.052). However, 81% of patients who received methylprednisolone also received tocilizumab. The number of days with hyperglycemia was similar in the two groups. Methylprednisolone was independently associated with increased VFDs and shortened hospital length of stay. The combination of methylprednisolone and tocilizumab was associated with a higher rate of positive blood cultures. Further trials are needed to evaluate the benefits and safety of methylprednisolone in moderate or severe COVID-19 ARDS.
关于甲泼尼龙对因2019冠状病毒病（COVID-19）导致急性呼吸窘迫综合征（ARDS）且需要有创机械通气患者的疗效，相关数据有限。我们旨在确定甲泼尼龙是否与这类患者无呼吸机天数（VFDs）的增加相关。回顾性单中心研究。重症监护病房。纳入了2020年3月1日至5月29日期间因确诊感染严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）且需要有创机械通气的所有ARDS患者。无。主要结局是前28天的无呼吸机天数（VFDs）。定义为存活且未使用机械通气。基于Fine和Gray的比例亚风险模型，采用竞争风险回归分析主要结局。第28天之前的死亡被视为竞争事件。共有77例患者符合纳入标准。32例患者（41.6%）接受了甲泼尼龙。中位剂量为1mg·kg（四分位间距：1 - 1.3mg·kg），中位疗程为5天（四分位间距：5 - 7天）。接受甲泼尼龙的患者在前28天的平均无呼吸机天数为18.8天（95%置信区间，16.6 - 20.9），而未接受甲泼尼龙的患者为14.2天（95%置信区间，12.6 - 16.7）（差异为4.61，95%置信区间，1.10 - 8.12，P = 0.001）。在多变量竞争风险回归分析中，在调整潜在混杂因素（呼吸机设置、俯卧位、器官功能衰竭支持、疾病严重程度、托珠单抗和炎症标志物）后，甲泼尼龙与更多的无呼吸机天数独立相关（亚风险比：0.10，95%置信区间：0.02 - 0.45，P = 0.003）。两组的医院死亡率无差异（31.2%对28.9%，P = 0.82）。甲泼尼龙组的住院时间显著更短（24天[四分位间距：15 - 41天]对37天[四分位间距：23 - 52天]，P = 0.046）。接受甲泼尼龙的患者血培养阳性发生率更高（37.5%对17.8%，P = 0.052）。然而，81%接受甲泼尼龙的患者也接受了托珠单抗。两组高血糖天数相似。甲泼尼龙与无呼吸机天数增加和住院时间缩短独立相关。甲泼尼龙和托珠单抗联合使用与更高的血培养阳性率相关。需要进一步试验来评估甲泼尼龙在中度或重度COVID-19 ARDS中的益处和安全性。
