托珠单抗治疗重症至危重型冠状病毒病2019 (COVID-19)患者

S.S.O. Aparece-Solis, R. Perez, A.L.Y. Ong, M. Cañete, A. Rafanan
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引用次数: 0

摘要

基本原理。在菲律宾,Tocilizumab是一种研究药物,我们的指导方针允许将其用于SARS-CoV-2重症至危重患者。当细胞因子激增已经发生时,托珠单抗通常在插管期间或之后给予。我们假设Tocilizumab的给药时间也可能影响其作为治疗的有效性。方法。我们对2020年3月1日至8月30日在重症监护病房住院的所有患者进行了回顾性观察研究,分析其插管时间(“早期”或插管前或无创通气与“晚期”或当日或之后)对插管后28天死亡率和生存率的影响。结果。重症监护室收治了90名重症至危重症患者。基线特征如表1所示。给予托珠单抗68例(76%),死亡率为47.06% (n=32)。这与未给予Tocilizumab的患者的54.54%(12/22)死亡率相当,(p=0.541)。两组都接受了类似的标准治疗,包括使用地塞米松,在发布COVID - 19治疗(恢复)随机评估试验结果后,于6月开始使用地塞米松。在接受Tocilizumab治疗的68例患者中,27例(30.7%)患者“早期”接受药物治疗,插管或无创通气前平均天(±SD)为3.96±3.46,41例患者“较晚”接受药物治疗,平均天(±SD)为0.762±3.18。早期组28天死亡率为29.63%(8/27),显著低于晚期组的58.54% (24/41)(p=0.019)。早期组插管后的平均生存天数明显更好(26.21 vs. 19.56;p=0.0008)。早期单独使用托珠单抗的风险比(调整协变量后)为0.2744268(95%置信区间,0.0842749至0.8936242,p=0.032),而同时使用地塞米松和托珠单抗的风险比为0.3387582 (95% ci: 0.1327466至0.8644829,p=0.024)。结论。正如早期数据显示的那样,Tocilizumab可能潜在地改善炎症反应,这可能潜在地防止插管。我们的数据本身受其回顾性性质的限制,但它表明,在细胞因子风暴之后,当呼吸衰竭随之而来时,晚给药Tocilizumab可能对患者有害。我们使用Cox多元回归的风险比确实显示,在呼吸衰竭之前给予重症患者Tocilizumab可能会提高生存率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Tocilizumab Treatment in Severe to Critical Coronavirus Disease 2019 (COVID-19) Patients
Rationale. In the Philippines, Tocilizumab is an investigational drug and our guidelines had allowed its use in severe to critical patients with SARS-CoV-2. Tocilizumab was often given during or after intubation when the cytokine surge has already occurred. We hypothesized that the timing of administration of Tocilizumab may also affect its effectiveness as a treatment. Methods. We conducted a retrospective observational study of all patients admitted in our intensive care unit from March 1 to August 30, 2020 analyzing the effect of its timing relative to intubation (“early” or given prior to intubation or noninvasive ventilation vs “late” or given on the day or after) on 28-day mortality and survival post-intubation. Results. Ninety severe to critically ill patients were admitted at the ICU. The baseline characteristics are shown in Table 1. Tocilizumab was given to 68 (76%) and their mortality rate was 47.06% (n=32). This was comparable to the 54.54% (12/22) mortality rate of the patients not given Tocilizumab, (p=0.541). Both groups received similar standard of care, including the use of Dexamethasone, which was started in June, after the release of the Randomized Evaluation of COVID 19 Therapy (RECOVERY) trial results. Of the 68 patients who received Tocilizumab, 27 (30.7%) received the drug “early' with a mean day (±SD) of 3.96 ±3.46 prior to intubation or noninvasive ventilation while 41 received it “late” with a mean day (±SD) of 0.762 ± 3.18. The 28-day mortality in the early group was 29.63% (8/27) which was significantly lower than the 58.54%, (24/41) in the late group (p=0.019). Their mean days of survival post intubation was significantly better for the early group (26.21 vs. 19.56;p=0.0008). The hazards ratios (after adjusting for covariates) for early Tocilizumab alone is 0.2744268 (95% confidence interval, 0.0842749 to 0.8936242, p=0.032) while that of both Dexamethasone and Tocilizumab use is 0.3387582 (95% ci: 0.1327466 to 0.8644829, p=0.024). Conclusion. Tocilizumab may potentially ameliorate the inflammatory response as has been shown by early data and this may potentially prevent intubation. Our data is inherently limited by its retrospective nature but it shows that late administration of Tocilizumab after the cytokine storm when respiratory failure has ensued may be detrimental to patients. Our hazards ratios using Cox multiple regression did show that giving Tocilizumab to severely ill patients prior to respiratory failure may improve survival.
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