Watanabe Atsuyuki, Inokuchi Ryota, Kuno Toshiki, Uda Kazuaki, Komiyama Jun, Adomi Motohiko, Ishisaka Yoshiko, Abe Toshikazu, Tamiya Nanako, Iwagami Masao
Division of Hospital Medicine, University of Tsukuba Hospital, Tsukuba, Japan.
Department of Health Services Research, Institute of Medicine, University of Tsukuba, Tsukuba, Japan.
Crit Care Explor. 2023 Mar 27;5(4):e0886. doi: 10.1097/CCE.0000000000000886. eCollection 2023 Apr.
UNLABELLED: Although pulse (high-dose) methylprednisolone therapy can hypothetically control immune system flare-ups effectively, the clinical benefit of pulse methylprednisolone compared with dexamethasone in COVID-19 remains inconclusive. OBJECTIVES: To compare pulse methylprednisolone to dexamethasone as a COVID-19 treatment. DESIGN SETTING AND PARTICIPANTS: Using a Japanese multicenter database, we identified adult patients admitted for COVID-19 and discharged between January 2020 and December 2021 treated with pulse methylprednisolone (250, 500, or 1,000 mg/d) or IV dexamethasone (≥ 6 mg/d) at admission day 0 or 1. MAIN OUTCOMES AND MEASURES: The primary outcome was in-hospital mortality. Secondary outcomes were 30-day mortality, new ICU admission, insulin initiation, fungal infection, and readmission. Multivariable logistic regression was conducted to differentiate the dose of pulse methylprednisolone (250, 500, or 1,000 mg/d). Additionally, subgroup analyses by characteristics such as the need for invasive mechanical ventilation (IMV) were also conducted. RESULTS: A total of 7,519, 197, 399, and 1,046 patients received dexamethasone, 250, 500, and 1,000 mg/d of methylprednisolone, respectively. The crude in-hospital mortality was 9.3% (702/7,519), 8.6% (17/197), 17.0% (68/399), and 16.2% (169/1,046) for the different doses, respectively. The adjusted odds ratio (95% CI) was 1.26 (0.69-2.29), 1.48 (1.07-2.04), and 1.75 (1.40-2.19) in patients starting 250, 500, and 1,000 mg/d of methylprednisolone, respectively, compared with those starting dexamethasone. In subgroup analyses, the adjusted odds ratio of in-hospital mortality was 0.78 (0.25-2.47), 1.12 (0.55-2.27), and 1.04 (0.68-1.57) in 250, 500, and 1,000 mg/d of methylprednisolone, respectively, among patients with IMV, whereas the adjusted odds ratio was 1.54 (0.77-3.08), 1.62 (1.13-2.34), and 2.14 (1.64-2.80) among patients without IMV. CONCLUSIONS AND RELEVANCE: Higher doses of pulse methylprednisolone (500 or 1,000 mg/d) may be associated with worse COVID-19 outcomes when compared with dexamethasone, especially in patients not on IMV.
未标注：虽然脉冲式（高剂量）甲泼尼龙疗法理论上可以有效控制免疫系统的突然发作，但在新冠肺炎中，与地塞米松相比，脉冲式甲泼尼龙的临床益处仍不明确。 目的：比较脉冲式甲泼尼龙与地塞米松作为新冠肺炎治疗方法的效果。 设计、背景与参与者：利用一个日本多中心数据库，我们确定了2020年1月至2021年12月期间因新冠肺炎入院并出院的成年患者，这些患者在入院第0天或第1天接受了脉冲式甲泼尼龙（250、500或1000毫克/天）或静脉注射地塞米松（≥6毫克/天）治疗。 主要结局与测量指标：主要结局是住院死亡率。次要结局包括30天死亡率、新入住重症监护病房、开始使用胰岛素、真菌感染和再次入院情况。进行多变量逻辑回归以区分脉冲式甲泼尼龙的剂量（250、500或1000毫克/天）。此外，还按是否需要有创机械通气（IMV）等特征进行了亚组分析。 结果：分别有7519、197、399和1046名患者接受了地塞米松、250毫克/天、500毫克/天和1000毫克/天的甲泼尼龙治疗。不同剂量组的粗住院死亡率分别为9.3%（702/7519）、8.6%（17/197）、17.0%（68/399）和16.2%（169/1046）。与开始使用地塞米松的患者相比,开始使用250毫克/天、500毫克/天和1000毫克/天甲泼尼龙的患者调整后的比值比（95%可信区间）分别为1.26（0.69 - 2.29）、1.48（1.07 - 2.04）和1.75（1.40 - 2.19）。在亚组分析中，有创机械通气患者中，250毫克/天、500毫克/天和1000毫克/天甲泼尼龙组的住院死亡率调整后的比值比分别为0.78（0.25 - 2.47）、1.12（0.55 - 2.27）和1.04（0.68 - 1.57）；而在无创机械通气患者中，调整后的比值比分别为1.54（0.77 - 3.08）、1.62（1.13 - 2.34）和2.14（1.64 - 2.80）。 结论与意义：与地塞米松相比，较高剂量的脉冲式甲泼尼龙（500或1000毫克/天）可能与更差的新冠肺炎结局相关，尤其是在不需要有创机械通气的患者中。
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