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[大学生论坛]:探究为重症监护状态下有胃肠道出血风险的患者使用的泮托拉唑

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蓝色的大海 发表于 2019-1-3 22:43:44 | 显示全部楼层 |阅读模式
Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU
探究为重症监护状态下有胃肠道出血风险的患者使用的泮托拉唑



Abstract
摘要


Background
Prophylaxis for gastrointestinal stress ulceration is frequently given to patients in the intensive care unit (ICU), but its risks and benefits are unclear.
背景
重症监护室(ICU)患者经常接受胃肠道应激性溃疡的预防,但其风险和益处目前尚不清楚。


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.
研究方法
本试验测试范围为欧洲,是采用多中心法和单盲法的平行组试验。如果是在急性条件下(即非计划性地)接收进入重症监护室或者有胃肠道出血风险的成年病人,会随机分组,在ICU监护期内每天摄入40 mg的静脉注射泮托拉唑(质子泵抑制剂)或安慰剂。研究结果的主要指标是随机分组后90天内的死亡案例。


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.
研究结果
我们共计登记了3298名患者;1645名随机分到了泮托拉唑组,1653名随机分到了安慰剂组。研究结果主要指标数据对3282名患者有效(占比99.5%)。试验进行了90天,泮托拉唑组有510名患者(占比31.1%),安慰剂组有499名患者(占比30.4%)已经死亡(相对风险度为1.02;95%置信区间[CI] 0.91 ~ 1.13; P = 0.76)。在ICU监护期内,泮托拉唑组有21.9%的患者、安慰剂组有22.6%的患者出现了至少一种具有重要临床意义的结果(包括胃肠出血、肺炎、梭菌深度感染或心肌缺血)(相对风险度0.96;95%置信区间0.83 ~ 1.11)。泮托拉唑组有2.5%的患者出现了具有重要临床意义的胃肠道出血,而安慰剂组为4.2%。而90天内出现感染或严重不良反应症状的数量以及在没有生命补给情况下存活的天数所占的百分比,两组的数据是差不多的。


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.)
结论
对于处于重症监护状态下有胃肠道出血风险的成年患者来说,不管是摄入泮托拉唑还是摄入安慰剂,90天内死亡率和有重要临床意义事件的数量都是差不多的。






作者:Mette Krag, M.D., Ph.D., Søren Marker, M.D., Anders Perner, M.D., Ph.D., Jørn Wetterslev, M.D., Ph.D., Matt P. Wise, M.D., Ph.D., Joerg C. Schefold, M.D., Frederik Keus, M.D., Ph.D., Anne B. Guttormsen, M.D., Ph.D., Stepani Bendel, M.D., Ph.D., Mark Borthwick, M.Sc., Theis Lange, Ph.D., Bodil S. Rasmussen, M.D., Ph.D., Martin Siegemund, M.D., Helle Bundgaard, M.D., Ph.D., Thomas Elkmann, M.D., D.M.Sc., Jacob V. Jensen, M.D., Rune D. Nielsen, M.D., Lisbeth Liboriussen, M.D., Morten H. Bestle, M.D., Ph.D., Jeanie M. Elkjær, M.D., Dorte F. Palmqvist, M.D., Minna Bäcklund, M.D., Ph.D., Jon H. Laake, M.D., Ph.D., Per M. Bådstøløkken, M.D., Juha Grönlund, M.D., Ph.D., Olena Breum, M.D., Akil Walli, M.D., Robert Winding, M.D., Susanne Iversen, M.D., Inge-Lise Jarnvig, M.D., Jonathan O. White, M.D., Björn Brand, M.D., Martin B. Madsen, M.D., Lars Quist, M.D., Klaus J. Thornberg, M.D., Anders Møller, M.D., Jørgen Wiis, M.D., Anders Granholm, B.M.Sc., Carl T. Anthon, M.D., Tine S. Meyhoff, M.D., Peter B. Hjortrup, M.D., Ph.D., Søren R. Aagaard, M.D., Jo B. Andreasen, M.D., Ph.D., Christina A. Sørensen, M.D., Pernille Haure, M.D., Jacob Hauge, M.D., Alexa Hollinger, M.D., Jonas Scheuzger, M.D., Daniel Tuchscherer, M.D., Thierry Vuilliomenet, M.D., Jukka Takala, M.D., Ph.D., Stephan M. Jakob, M.D., Ph.D., Marianne L. Vang, M.D., Kim B. Pælestik, M.D., Karen L.D. Andersen, M.D., Iwan C.C. van der Horst, M.D., Ph.D., Willem Dieperink, Ph.D., Jesper Fjølner, M.D., Cilia K.W. Kjer, B.M.Sc., Christine Sølling, M.D., Ph.D., Christoffer G. Sølling, M.D., Ph.D., Johanna Karttunen, M.D., Matt P.G. Morgan, M.D., Ph.D., Brit Sjøbø, R.N., Janus Engstrøm, B.Sc., Birgit Agerholm-Larsen, Ph.D., and Morten H. Møller, M.D., Ph.D. for the SUP-ICU trial group
期刊名称:The New England Journal of Medicine
发表时间:2018-12-06
N Engl J Med 2018; 379:2199-2208 | DOI: 10.1056/NEJMoa1714919


2015级英语翻译 卢君帅 3151201059

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