芦可替尼用于新型冠状病毒肺炎相关细胞因子风暴的紧急治疗：一项扩大可及性研究的结果
Ruxolitinib for Emergency Treatment of COVID-19-Associated Cytokine Storm: Findings From an Expanded Access Study.
作者信息
Weinstein Jeffrey, Jagan Nikhil, Lorthridge-Jackson Shawnta, Hamer-Maansson J E, Squier Peg
机构信息
Department of Clinical Quality and Infection Prevention and Control, Kettering Health Network, Dayton, Ohio, USA.
Department of Medicine, Creighton University School of Medicine, Omaha, Nebraska, USA.
出版信息
Clin Respir J. 2025 Apr;19(4):e70050. doi: 10.1111/crj.70050.
INTRODUCTION
This expanded access program (EAP) provided ruxolitinib (oral, selective Janus kinase [JAK]1/JAK2 inhibitor) for emergency treatment of COVID-19-associated cytokine storm in patients eligible for hospitalization (NCT04355793).
METHODS
Patients received ruxolitinib 5 mg twice daily (preferred regimen when tolerated) or once daily for ≤ 14 days, or until determination of no clinical benefit was made. Outcomes were clinical status, physician-assessed clinical benefit, and serious adverse event (SAE) incidence.
RESULTS
Of 312 patients, 45.5% achieved ≥ 1-point clinical status improvement. Physician-assessed clinical benefit was reported in 42.6% of evaluable patients. SAEs occurred in 42.9%, with 2.6% experiencing an SAE suspected to be ruxolitinib related.
CONCLUSIONS
Overall, some hospitalized patients with COVID-19-associated cytokine storm who received ruxolitinib experienced clinical status improvement; ruxolitinib was well tolerated.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT04355793.
引言
该扩大准入项目（EAP）为符合住院条件的新冠肺炎相关细胞因子风暴患者提供了芦可替尼（口服，选择性Janus激酶[JAK]1/JAK2抑制剂）用于紧急治疗（NCT04355793）。
方法
患者接受芦可替尼，每日两次，每次5毫克（耐受时的首选方案），或每日一次，持续≤14天，或直至确定无临床获益。观察指标为临床状态、医生评估的临床获益以及严重不良事件（SAE）发生率。
结果
在312例患者中，45.5%的患者临床状态改善≥1分。42.6%的可评估患者报告有医生评估的临床获益。SAE发生率为42.9%，其中2.6%的患者发生疑似与芦可替尼相关的SAE。
结论
总体而言，一些接受芦可替尼治疗的新冠肺炎相关细胞因子风暴住院患者临床状态有所改善；芦可替尼耐受性良好。
试验注册
ClinicalTrials.gov标识符：NCT04355793。
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