Department of Nephrology, Tokyo Saiseikai Central Hospital, 1-4-17 Mita, Minato-ku, Tokyo, 108-0073, Japan.
Department of Rheumatology, Keio University School of Medicine, Tokyo, Japan.
Clin Exp Nephrol. 2022 Jan;26(1):75-85. doi: 10.1007/s10157-021-02126-4. Epub 2021 Aug 26.
Critical coronavirus disease 2019 (COVID-19) has a high fatality rate, especially in hemodialysis (HD) patients, with this poor prognosis being caused by systemic hyperinflammation; cytokine storms. Steroid pulse therapy or tocilizumab (TCZ) have insufficient inhibitory effects against cytokine storms in critical cases. This study evaluated the clinical effects and safety of combining steroid pulse therapy and TCZ.
From September 2020 to May 2021, 201 patients with COVID-19 were admitted to our hospital. Before February 2021, patients with an oxygen demand exceeding 8 L/min were intubated and treated with standard therapy (dexamethasone and antiviral therapy). After February 2021, patients underwent high-flow nasal cannula oxygen therapy and were treated with TCZ (8 mg/kg) and methylprednisolone (mPSL) (500 mg/day [≤ 75 kg], 1000 mg/day [> 75 kg]) for 3 days. We compared background characteristics, laboratory findings, and prognosis between non-HD and HD patients and between patients who received and did not receive TCZ and mPSL pulse therapy.
Among non-HD patients, the TCZ + mPSL pulse group had significantly higher survival rates and lower secondary infection rates (p < 0.05), than the standard therapy group. All HD patients in the standard therapy group with oxygen demand exceeding 8 L/min died. Contrastingly, all patients in the TCZ + mPSL pulse group survived, with their oxygen demand decreasing to 0-1 L/min within 3 weeks post-administration.
TCZ combined with mPSL pulse therapy improved the survival rate without significant adverse events in critical HD and non-HD patients with COVID-19 by strongly suppressing systemic hyperinflammation.
严重的 2019 冠状病毒病（COVID-19）具有很高的死亡率，尤其是在血液透析（HD）患者中，这种不良预后是由全身过度炎症引起的；细胞因子风暴。在危急情况下，类固醇脉冲疗法或托珠单抗（TCZ）对细胞因子风暴的抑制作用不足。本研究评估了联合使用类固醇脉冲疗法和 TCZ 的临床效果和安全性。
从 2020 年 9 月至 2021 年 5 月，共有 201 例 COVID-19 患者入住我院。在 2021 年 2 月之前，需要 8 L/min 以上氧气的患者需要插管，并接受标准治疗（地塞米松和抗病毒治疗）。2021 年 2 月后，患者接受高流量鼻导管吸氧治疗，并接受 TCZ（8 mg/kg）和甲泼尼龙（mPSL）（500 mg/天[≤75 kg]，1000 mg/天[>75 kg]）治疗 3 天。我们比较了非血液透析患者和血液透析患者之间、接受和未接受 TCZ 和 mPSL 脉冲治疗的患者之间的背景特征、实验室检查结果和预后。
在非血液透析患者中，TCZ+mPSL 脉冲组的生存率明显高于标准治疗组，二次感染率较低（p<0.05）。标准治疗组所有需要 8 L/min 以上氧气的血液透析患者均死亡。相比之下，TCZ+mPSL 脉冲组的所有患者均存活，且给药后 3 周内其氧气需求降至 0-1 L/min。
TCZ 联合 mPSL 脉冲疗法通过强力抑制全身过度炎症，提高了严重 COVID-19 非血液透析和血液透析患者的生存率，且无明显不良事件。
