侵袭性机械通气期间的应激性溃疡预防。
Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation.
机构信息
From From the Departments of Medicine (D.C., G.G., W.A., M.M., E.D., J.C.D., J.L.Y.T., B. Rochwerg, T.K.), Health Research Methods, Evidence, and Impact (D.C., N.Z., G.G., D.H.-A., G.R., W.A., M.M., L.H., F.C., J.C.D., B. Rochwerg, F.X., L.T.), and Family Medicine (M.V.), McMaster University, Hamilton, ON, the Department of Medicine, University of British Columbia, Vancouver, BC (B.D.), Population Health and Optimal Health Practice Research Unit, Centre Hospitalier Universitaire de Québec, Université Laval Research Center, Quebec, QC (F. Lauzier), St. Joseph's Healthcare Hamilton Research Institute, Hamilton, ON (D.C., F.C., G.G., L.S., L.T., N.Z.), Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto (J. Marshall, K.B., A. Goffi, M.E.W., R.F., N.K.J.A., S.M.); Queen's University, Kingston, ON (J. Muscedere), the Department of Medicine, Critical Care, University of Ottawa, Ottawa (S.E.), Dalhousie University, Halifax, NS (R.H., O.L.), Niagara Health, St. Catharines, ON (E.D., J.L.Y.T.), Université de Sherbrooke, Sherbrooke, QC (F. Lamontagne, F.D., C.S.A.), Brantford General Hospital, Brantford, ON (B. Reeve), North York General Hospital, Toronto (A. Geagea), the Department of Critical Care Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB (D.N., K.F.), the University of Manitoba, Winnipeg (G.V.-G., R.Z.), Royal Jubilee Hospital, Victoria, BC (D.O., G.W.), Unity Health Toronto-St. Michael's Hospital, Toronto (K.B., A. Goffi), Vancouver General Hospital, Vancouver, BC (W.H.), Nanaimo Regional General Hospital, Nanaimo, BC (D.F.), the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto (R.F., N.K.J.A.), Western University, London, ON (I.B., T.M.), William Osler Hospital, Brampton, ON (A.B., S.T.), Mount Sinai Hospital, Toronto (S.M.), Cambridge Memorial Hospital, Cambridge, ON (I.M.), Centre Hospitalier de l'Université de Montréal (E.C.) and Hôpital du Sacré-Coeur de Montréal (E.C., Y.A.C.), University of Montreal (D.W.), Montreal, Université Laval, Quebec, QC (P.A.), the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton (O.G.R., V.L.), Meakins-Christie Laboratories and Translational Research in Respiratory Diseases Program, Research Institute of the McGill University Health Centre (A.S.K.), and the Department of Critical Care, McGill University (A.S.K., K.K.), Montreal, the Ottawa Hospital Research Institute, Ottawa (S. Kanji), the Department of Medicine, University of Saskatchewan, and the Department of Critical Care, Saskatchewan Health Authority, Regina (E.S.), Royal Columbia Hospital, New Westminster, BC (S.R.), Centre Intégré Universitaire de Santé et de Services Sociaux de l'Est-de-l'Île-de-Montréal, Hôpital Maisonneuve-Rosemont, Montreal (F.M.), Université Laval, Faculté de Médecine, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (F. Lellouche), the Department of Medicine, Windsor Regional Hospital, Windsor, ON (A.R.), Grand River Hospital, Kitchener, ON (P.H.), St. Joseph's Hospital, Toronto (R.C.), St. John Regional Hospital, St. John, NB (M.T.) - all in Canada; the University of Melbourne, Melbourne, VIC (A.D.); the George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales (M.H., J. Myburgh, S. Knowles, N.H., B.V., D.R., L.B., S.F.) and St. George Hospital (J. Myburgh), Sydney, Royal Melbourne Hospital, Melbourne, VIC (K.M.B.), and the University of Adelaide, Adelaide, SA (M.C., A.P.) - all in Australia; King Abdullah International Medical Research Center and King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia (Y.M.A.); King's College London (M.O.) and School of Public Health, Faculty of Medicine, Imperial College (S.F.), London; Medical Research Institute of New Zealand, Wellington, New Zealand (P.Y.); the Department of Anesthesia, Critical Care Medicine, and Pain Medicine, Kuwait Extracorporeal Life Support Program, Al-Amiri Hospital, Ministry of Health, Kuwait City, Kuwait (A.A.-F.); Pontifical Catholic University, Belo Horizonte, Brazil (G.R.); the University of Nebraska Medical Center, Omaha (D.J.); the Department of Pulmonary and Critical Care Medicine, Maroof International Hospital, Islamabad, Pakistan (M.I.); and Midwestern University, College of Pharmacy, Glendale, AZ (J.F.B.).
出版信息
N Engl J Med. 2024 Jul 4;391(1):9-20. doi: 10.1056/NEJMoa2404245. Epub 2024 Jun 14.
BACKGROUND
Whether proton-pump inhibitors are beneficial or harmful for stress ulcer prophylaxis in critically ill patients undergoing invasive ventilation is unclear.
METHODS
In this international, randomized trial, we assigned critically ill adults who were undergoing invasive ventilation to receive intravenous pantoprazole (at a dose of 40 mg daily) or matching placebo. The primary efficacy outcome was clinically important upper gastrointestinal bleeding in the intensive care unit (ICU) at 90 days, and the primary safety outcome was death from any cause at 90 days. Multiplicity-adjusted secondary outcomes included ventilator-associated pneumonia, infection, and patient-important bleeding.
RESULTS
A total of 4821 patients underwent randomization in 68 ICUs. Clinically important upper gastrointestinal bleeding occurred in 25 of 2385 patients (1.0%) receiving pantoprazole and in 84 of 2377 patients (3.5%) receiving placebo (hazard ratio, 0.30; 95% confidence interval [CI], 0.19 to 0.47; P<0.001). At 90 days, death was reported in 696 of 2390 patients (29.1%) in the pantoprazole group and in 734 of 2379 patients (30.9%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.85 to 1.04; P = 0.25). Patient-important bleeding was reduced with pantoprazole; all other secondary outcomes were similar in the two groups.
CONCLUSIONS
Among patients undergoing invasive ventilation, pantoprazole resulted in a significantly lower risk of clinically important upper gastrointestinal bleeding than placebo, with no significant effect on mortality. (Funded by the Canadian Institutes of Health Research and others; REVISE ClinicalTrials.gov number, NCT03374800.).
背景
对于接受有创性通气的危重症患者，质子泵抑制剂用于预防应激性溃疡是有益还是有害尚不清楚。
方法
在这项国际性、随机试验中，我们将接受有创性通气的成年危重症患者随机分为静脉注射泮托拉唑（剂量为每天 40 毫克）或匹配的安慰剂组。主要疗效结局是 90 天内 ICU 内临床重要的上消化道出血，主要安全性结局是 90 天内任何原因导致的死亡。多重调整后的次要结局包括呼吸机相关性肺炎、感染和患者重要性出血。
结果
共有 68 个 ICU 中的 4821 名患者接受了随机分组。接受泮托拉唑治疗的 2385 名患者中有 25 名（1.0%）发生临床重要的上消化道出血，而接受安慰剂治疗的 2377 名患者中有 84 名（3.5%）发生（风险比，0.30；95%置信区间 [CI]，0.19 至 0.47；P<0.001）。在 90 天时，泮托拉唑组有 2390 名患者中的 696 名（29.1%）和安慰剂组有 2379 名患者中的 734 名（30.9%）报告死亡（风险比，0.94；95%CI，0.85 至 1.04；P=0.25）。泮托拉唑组患者重要性出血减少；两组的其他次要结局相似。
结论
在接受有创性通气的患者中，泮托拉唑与安慰剂相比，上消化道出血的临床重要性显著降低，死亡率无显著差异。（由加拿大卫生研究院等资助；REVISE ClinicalTrials.gov 编号，NCT03374800。）
Zotero 插件