重症监护病房有胃肠道出血风险的患者使用泮托拉唑。
Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU.
机构信息
From the Department of Intensive Care (M.K., S.M., A.P., I.-L.J., J.O.W., B.B., M.B.M., L.Q., K.J.T., A.M., J. Wiis, A.G., C.T.A., T.S.M, P.B.H., M.H.M.), Copenhagen Trial Unit, Center for Clinical Intervention Research (J. Wetterslev, J.E.), and the Department of Neurointensive Care (R.D.N, C.S.), Rigshospitalet, Bispebjerg and Frederiksberg Hospital (D.F.P.), and the Section of Biostatistics (T.L.), University of Copenhagen, Copenhagen, Center for Research in Intensive Care (M.K., S.M., A.P., J. Wetterslev, B.S.R., T.L., B.A.-L., M.H.M.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A., J.B.A., C.A.S., P.H., J. Hauge), Randers Hospital, Randers (H.B., M.L.V., K.B.P., K.L.D.A.), Aarhus University Hospital, Nørrebrogade (T.E., J.F.), and Aarhus University Hospital, Skejby (O.B.) - both in Aarhus, Zealand University Hospital, Køge (J.V.J., C.K.W.K.), Viborg Hospital, Viborg (L.L., C.G.S.), Nordsjællands Hospital, University of Copenhagen, Hillerød (M.H.B.), Holbæk Hospital, Holbæk (J.M.E.), Zealand University Hospital, Roskilde (A.W.), Herning Hospital, Herning (R.W.), and Slagelse Hospital, Slagelse (S.I.) - all in Denmark; the Center for Statistical Science, Peking University, Beijing (T.L.); University Hospital of Wales, Cardiff (M.P.W., M.P.G.M.), and Oxford University Hospitals NHS Foundation Trust, Oxford (M. Borthwick) - both in the United Kingdom; Inselspital, Bern University Hospital, University of Bern, Bern (J.C.S., J.T., S.M.J.), and Basel University Hospital, Basel (M.S., A.H., J.S., D.T., T.V.) - both in Switzerland; University Medical Center Groningen, University of Groningen, Groningen, the Netherlands (F.K., I.C.C.H., W.D.); Haukeland University Hospital, University of Bergen, Bergen (A.B.G., B.S.), and Oslo University Hospital (J.H.L.) and Akershus University Hospital (P.M.B.), Oslo - all in Norway; and Kuopio University Hospital, Kuopio (S.B., J.K.), Helsinki University Hospital, Helsinki (M. Bäcklund), and Turku University Hospital, Turku (J.G.) - all in Finland.
出版信息
N Engl J Med. 2018 Dec 6;379(23):2199-2208. doi: 10.1056/NEJMoa1714919. Epub 2018 Oct 24.
BACKGROUND
Prophylaxis for gastrointestinal stress ulceration is frequently given to patients in the intensive care unit (ICU), but its risks and benefits are unclear.
METHODS
In this European, multicenter, parallel-group, blinded trial, we randomly assigned adults who had been admitted to the ICU for an acute condition (i.e., an unplanned admission) and who were at risk for gastrointestinal bleeding to receive 40 mg of intravenous pantoprazole (a proton-pump inhibitor) or placebo daily during the ICU stay. The primary outcome was death by 90 days after randomization.
RESULTS
A total of 3298 patients were enrolled; 1645 were randomly assigned to the pantoprazole group and 1653 to the placebo group. Data on the primary outcome were available for 3282 patients (99.5%). At 90 days, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died (relative risk, 1.02; 95% confidence interval [CI], 0.91 to 1.13; P=0.76). During the ICU stay, at least one clinically important event (a composite of clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection, or myocardial ischemia) had occurred in 21.9% of patients assigned to pantoprazole and 22.6% of those assigned to placebo (relative risk, 0.96; 95% CI, 0.83 to 1.11). In the pantoprazole group, 2.5% of patients had clinically important gastrointestinal bleeding, as compared with 4.2% in the placebo group. The number of patients with infections or serious adverse reactions and the percentage of days alive without life support within 90 days were similar in the two groups.
CONCLUSIONS
Among adult patients in the ICU who were at risk for gastrointestinal bleeding, mortality at 90 days and the number of clinically important events were similar in those assigned to pantoprazole and those assigned to placebo. (Funded by Innovation Fund Denmark and others; SUP-ICU ClinicalTrials.gov number, NCT02467621 .).
背景
在重症监护病房（ICU）中，经常会给患者预防性使用胃肠道应激性溃疡药物，但这种治疗的风险和获益并不明确。
方法
在这项欧洲多中心、平行分组、双盲试验中，我们将因急性病（即非计划性入院）而收入 ICU 且有胃肠道出血风险的成年患者随机分为两组，分别接受静脉注射泮托拉唑（质子泵抑制剂）40mg 或安慰剂，每天 1 次，疗程为 ICU 住院期间。主要结局为随机分组后 90 天内的死亡。
结果
共纳入 3298 例患者；1645 例患者被随机分入泮托拉唑组，1653 例患者分入安慰剂组。3282 例患者（99.5%）的主要结局数据可用。90 天时，泮托拉唑组 510 例（31.1%）患者和安慰剂组 499 例（30.4%）患者死亡（相对风险，1.02；95%置信区间[CI]，0.91 至 1.13；P=0.76）。在 ICU 住院期间，至少发生 1 项临床重要事件（临床重要胃肠道出血、肺炎、艰难梭菌感染或心肌缺血的复合事件）的患者中，泮托拉唑组占 21.9%，安慰剂组占 22.6%（相对风险，0.96；95%CI，0.83 至 1.11）。泮托拉唑组有 2.5%的患者发生临床重要胃肠道出血，安慰剂组为 4.2%。两组患者的感染或严重不良反应数量以及 90 天内无生命支持天数的百分比相似。
结论
在胃肠道出血风险较高的 ICU 成年患者中，泮托拉唑组与安慰剂组患者的 90 天死亡率和临床重要事件数量相似。（由丹麦创新基金和其他机构资助；SUP-ICU 临床试验.gov 编号，NCT02467621）。
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