加拿大汉密尔顿圣约瑟夫医院Deborah Cook团队研究了有创机械通气期间应激性溃疡的预防策略。这一研究成果于2024年6月14日发表在《新英格兰医学杂志》上。

质子泵抑制剂对接受有创通气的危重患者的应激性溃疡预防是有益还是有害尚不清楚。

在这项国际随机试验中，研究组将正在接受有创通气的危重成年人分配给静脉注射泮托拉唑（每日40 mg）或匹配的安慰剂。主要疗效结局是90天时在重症监护室（ICU）发生的具有临床意义的上消化道出血，主要安全性结局是90天后的全因死亡。多重性调整后的关键次要结局是呼吸机相关肺炎、艰难梭菌感染和患者大出血。

共有4821名患者在68个重症监护室接受了随机分组。2385名接受泮托拉唑治疗的患者中有25名（1.0%）发生了临床上重要的上消化道出血，2377名接受安慰剂治疗的患者（3.5%）中有84名发生（危险比，0.30；95%置信区间[CI]，0.19-0.47；P<0.001）。90天时，泮托拉唑组2390名患者中有696人（29.1%）死亡，安慰剂组2379名患者中有734人（30.9%）死亡（危险比为0.94；95%可信区间为0.85至1.04；P=0.025）。泮托拉唑患者大出血减少；两组的所有其他关键次要结局相似。

研究结果表明，在接受有创通气的患者中，与安慰剂相比，泮托拉唑显著降低了临床上重要的上消化道出血的风险，对死亡率没有显著影响。

附：英文原文

Title: Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation

Author: Deborah Cook, Adam Deane, Franois Lauzier, Nicole Zytaruk, Gordon Guyatt, Lois Saunders, Miranda Hardie, Diane Heels-Ansdell, Waleed Alhazzani, John Marshall, John Muscedere, John Myburgh, Shane English, Yaseen M. Arabi, Marlies Ostermann, Serena Knowles, Naomi Hammond, Kathleen M. Byrne, Marianne Chapman, Balasubramanian Venkatesh, Paul Young, Dorrilyn Rajbhandari, Alexis Poole, Abdulrahman Al-Fares, Gilmar Reis, Daniel Johnson, Mobeen Iqbal, Richard Hall, Maureen Meade, Lori Hand, Erick Duan, France Clarke, Joanna C. Dionne, Jennifer L.Y. Tsang, Bram Rochwerg, Timothy Karachi, Francois Lamontagne, Frédérick D’Aragon, Charles St. Arnaud, Brenda Reeve, Anna Geagea, Daniel Niven, Gloria Vazquez-Grande, Ryan Zarychanski, Daniel Ovakim, Gordon Wood, Karen E.A. Burns, Alberto Goffi, M. Elizabeth Wilcox, William Henderson, David Forrest, Rob Fowler, Neill K.J. Adhikari, Ian Ball, Tina Mele, Alexandra Binnie, Sebastien Trop, Sangeeta Mehta, Ingrid Morgan, Osama Loubani, Meredith Vanstone, Kirsten Fiest, Emmanuel Charbonney, Yiorgos A. Cavayas, Patrick Archambault, Oleksa G. Rewa, Vincent Lau, Arnold S. Kristof, Kosar Khwaja, David Williamson, Salmaan Kanji, Eric Sy, Brittany Dennis, Steve Reynolds, Francois Marquis, Franois Lellouche, Adam Rahman, Paul Hosek, Jeffrey F. Barletta, Robert Cirrone, Mark Tutschka, Feng Xie, Laurent Billot, Lehana Thabane, Simon Finfer

Issue&Volume: 2024-06-14

Abstract:

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 key secondary outcomes were ventilator-associated pneumonia, Clostridioides difficile 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 key 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.

DOI: NJ202406140000006

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2404245