在COVID-19的重症患者中使用simvastatin
, Thomas E Hills1, Elizabeth Lorenzi1
1From the Medical Research Institute of New Zealand, Wellington (T.E.H., S. McGuinness, A.M.T., C.J.M.), and Middlemore Hospital (T.E.H.), Te Toka Tumai Auckland City Hospital (T.E.H., S. McGuinness, R.L.P., C.J.M.), and the School of Nursing, University of Auckland (R.L.P.), Auckland - all in New Zealand; Berry Consultants, Austin, TX (E.L., L.R.B., M.A.D., M.F., A.M., C.T.S., R.J.L., S.M.B.); Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast (M. Shyamsundar, C.M.O., D.F.M.), the Department of Critical Care, Belfast Health and Social Care Trust (M. Shyamsundar, D.F.M.), and the Centre for Public Health, Queen's University Belfast, Belfast Health and Social Care Trust, and the Department of Health (I.S.Y.), Belfast, Imperial College London (F.A.-B., A.C.G.), the Intensive Care National Audit and Research Centre (C.A., D.A.H., L.L., A.J.M., P.R.M., K.M.R.), University College London Hospitals (R.H.), and Imperial College Healthcare NHS Trust (A.C.G.), London, the Institute for Regeneration and Repair (A. Beane) and the Centre for Inflammation Research (R.H., M.S.-H.), University of Edinburgh, Edinburgh, the Faculty of Health Sciences, University of Bristol, and Bristol Haematology and Oncology Centre, University Hospitals Bristol and Weston NHS Trust, Bristol (C.A.B.), and NHS Blood and Transplant, Oxford (L.J.E.) - all in the United Kingdom; Institut Hospitalo-Universitaire Prometheus, University Paris-Saclay, the Department of Intensive Care, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris, University Versailles Saint Quentin-University Paris-Saclay, the Laboratory of Infection and Inflammation-Unité 173, School of Medicine Simone Veil, University Versailles Saint Quentin-University Paris-Saclay, INSERM, and Fédération Hospitalo-Universitaire SEPSIS (Saclay and Paris Seine Nord Endeavor to Personalize Interventions for Sepsis) - all in Garches, France (D. Annane); King Saud bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia (Y.A.); Nepal Intensive Care Research Foundation, Kathmandu (D. Aryal); Mahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand (D. Aryal, A. Beane); Unity Health Toronto (Z.B., J.C.M., M. Santos), the Interdepartmental Division of Critical Care Medicine, University of Toronto, and Toronto General Hospital Research Institute (E.C.G.), Peter Munk Cardiac Centre at University Health Network (P.R.L.), and Keenan Centre for Biomedical Research (J.C.M.), Toronto, Université de Sherbrooke, Sherbrooke, QC (F.L.), McGill University Health Centre, Montreal (P.R.L.), the Faculty of Medicine, University of British Columbia, Vancouver (S. Murthy), the Population Health and Optimal Practices Research Unit, Centre Hospitalier Universitaire de Québec-Université Laval Research Center, and the Department of Anesthesiology and Critical Care Medicine, Université Laval, Quebec City (A.F.T.), and the University of Manitoba and CancerCare Manitoba, Winnipeg (R.Z.) - all in Canada; Julius Center for Health Sciences and Primary Care (M. Bonten, L.P.G.D.) and the Intensive Care Center (L.P.G.D.), University Medical Center Utrecht, Utrecht University, and the European Clinical Research Alliance on Infectious Diseases (M. Bonten), Utrecht, and Radboud University Medical Center, Nijmegen (F.V.) - all in the Netherlands; the Department of Anesthesiology and Intensive Care Medicine (F.M.B., S.W.) and the Institute for Infection Disease and Infection Control (S.W.), Jena University Hospital, Friedrich-Schiller University, and Leibniz Institute for Natural Product Research and Infection Biology, Hans Knöll Institute (S.W.) - both in Jena, Germany; the School of Public Health and Preventive Medicine (A. Burrell, A.C.C., C.G., A.M.H., Z.K.M., A.D.N., J.C.P., C.J.M., S.A.W.) and the School of Clinical Sciences (A.C.C.), Monash University, Alfred Hospital (A. Burrell, A.D.N.), and Monash Health (A.C.C., Z.K.M.), Melbourne, VIC, the Faculty of Medicine, University of Queensland, and the Intensive Care Unit, Princess Alexandra Hospital, Brisbane (P.S.K.), and St. John of God Health Care, Perth, WA (S.A.W.) - all in Australia; the Global Coalition for Adaptive Research, Larkspur (M. Buxton), the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine, Department of Medicine, and the Department of Anesthesia, University of California, San Francisco, San Francisco (C.S.C.), and Harbor-UCLA Medical Center, Torrance (R.J.L.) - all in California; the Department of Biomedical Sciences, Humanitas University, and IRCCS Humanitas Research Hospital, Milan (M.C.); National University Hospital Singapore, Singapore (M.E.C.); Dr. Kamakshi Memorial Hospital (D.J.) and Apollo Speciality Hospitals (E.R.) - both in Chennai, India; the University of Antwerp, Antwerp, Belgium (H.G.); National Intensive Care Surveillance-MORU, Colombo, Sri Lanka (R.H.); Ziauddin University, Karachi, Pakistan (M.H.); the University of Pittsburgh (D.T.H., B.J.M., M.D.N., C.W.S., D.C.A.) and the University of Pittsburgh Medical Center (D.T.H., B.J.M.) - both in Pittsburgh; Jikei University School of Medicine and the University of Tokyo, Tokyo (N.I.), and St. Marianna University School of Medicine, Yokohama Seibu Hospital, Yokohama (H.S.) - all in Japan; University College Dublin Clinical Research Centre, St. Vincent's University Hospital, Dublin (A.D.N.); Universidad de La Sabana and Clínica Universidad de La Sabana - both in Chia, Colombia (L.F.R.); the Division of Clinical and Translational Research, Division of Critical Care, Department of Anesthesiology, Washington University School of Medicine, St. Louis (P.S.); and the Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, Boston (B.T.T.).
在一项大型试验中,simvastatin没有显著改善严重病情的Covid-19患者的结果. 该研究没有发现明显的益处,严重的不良事件在simvastatin中更常见.
科学领域:
- 关键护理医学 关键护理医学
- 传染病 传染病 传染病
- 药理学 药理学是指药理学的学科.
背景情况:
- 在严重的COVID-19病例中,simvastatin的有效性尚不确定.
- 患有COVID-19的重症患者通常需要器官支持.
研究的目的:
- 为了评估simvastatin在重症COVID-19患者的疗效,在基线时不服用他类药物.
- 为了确定simvastatin是否改善器官支持无天,与没有他类药物相比.
主要方法:
- 一个适应性,随机,受控试验 (REMAP-CAP) 涉及2684名患者.
- 辛巴斯塔丁 (每天80毫克) 与没有他类药物,以无呼吸和心血管器官支持的日子作为主要结局,直到21日.
- 贝叶斯的等级顺序模型,预先指定了优越性和徒劳性的停止标准.
主要成果:
- 无器官支的中位数为11天,对照组为7天,对照组为11天 (后端中位数赔率比为1.15;优势概率为95.9%).
- 西姆瓦斯塔丁没有达到优越性值 (99%的概率).
- 与simvastatin一起观察到严重不良事件的增加,包括肝酶和肌酸酶的升高.
结论:
- 在重症COVID-19患者中,simvastatin没有表现出高于无他的优势.
- 由于COVID-19病例减少,招聘被停止,这影响了满足停止标准的能力.
- 该研究没有证实simvastatin作为这种患者群的有益治疗方法.
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