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Effect of Stress Ulcer Prophylaxis With Proton Pump Inhibitors vs Histamine-2 Receptor Blockers on In-Hospital Mortality Among ICU Patients Receiving Invasive Mechanical Ventilation: The PEPTIC Randomized Clinical Trial.

质子泵抑制剂与组胺-2 受体阻滞剂预防应激性溃疡对接受有创机械通气的 ICU 患者住院死亡率的影响: 消化性溃疡随机临床试验。

  • 影响因子:6.98
  • DOI:10.1001/jama.2019.22190
  • 作者列表:"PEPTIC Investigators for the Australian and New Zealand Intensive Care Society Clinical Trials Group, Alberta Health Services Critical Care Strategic Clinical Network, and the Irish Critical Care Trials Group.","Young PJ","Bagshaw SM","Forbes AB","Nichol AD","Wright SE","Bailey M","Bellomo R","Beasley R","Brickell K","Eastwood GM","Gattas DJ","van Haren F","Litton E","Mackle DM","McArthur CJ","McGuinness SP","Mouncey PR","Navarra L","Opgenorth D","Pilcher D","Saxena MK","Webb SA","Wiley D","Rowan KM
  • 发表时间:2020-01-17
Abstract

Importance:Proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs) are often prescribed for patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU). The comparative effect of these drugs on mortality is unknown. Objective:To compare in-hospital mortality rates using PPIs vs H2RBs for stress ulcer prophylaxis. Design, Setting, and Participants:Cluster crossover randomized clinical trial conducted at 50 ICUs in 5 countries between August 2016 and January 2019. Patients requiring invasive mechanical ventilation within 24 hours of ICU admission were followed up for 90 days at the hospital. Interventions:Two stress ulcer prophylaxis strategies were compared (preferential use with PPIs vs preferential use with H2RBs). Each ICU used each strategy sequentially for 6 months in random order; 25 ICUs were randomized to the sequence with use of PPIs and then use of H2RBs and 25 ICUs were randomized to the sequence with use of H2RBs and then use of PPIs (13 436 patients randomized by site to PPIs and 13 392 randomized by site to H2RBs). Main Outcomes and Measures:The primary outcome was all-cause mortality within 90 days during index hospitalization. Secondary outcomes were clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay. Results:Among 26 982 patients who were randomized, 154 opted out, and 26 828 were analyzed (mean [SD] age, 58 [17.0] years; 9691 [36.1%] were women). There were 26 771 patients (99.2%) included in the mortality analysis; 2459 of 13 415 patients (18.3%) in the PPI group died at the hospital by day 90 and 2333 of 13 356 patients (17.5%) in the H2RB group died at the hospital by day 90 (risk ratio, 1.05 [95% CI, 1.00 to 1.10]; absolute risk difference, 0.93 percentage points [95% CI, -0.01 to 1.88] percentage points; P = .054). An estimated 4.1% of patients randomized by ICU site to PPIs actually received H2RBs and an estimated 20.1% of patients randomized by ICU site to H2RBs actually received PPIs. Clinically important upper gastrointestinal bleeding occurred in 1.3% of the PPI group and 1.8% of the H2RB group (risk ratio, 0.73 [95% CI, 0.57 to 0.92]; absolute risk difference, -0.51 percentage points [95% CI, -0.90 to -0.12 percentage points]; P = .009). Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group. One adverse event (an allergic reaction) was reported in 1 patient in the PPI group. Conclusions and Relevance:Among ICU patients requiring mechanical ventilation, a strategy of stress ulcer prophylaxis with use of proton pump inhibitors vs histamine-2 receptor blockers resulted in hospital mortality rates of 18.3% vs 17.5%, respectively, a difference that did not reach the significance threshold. However, study interpretation may be limited by crossover in the use of the assigned medication. Trial Registration:anzctr.org.au Identifier: ACTRN12616000481471.

摘要

重要性: 在重症监护病房 (ICU),质子泵抑制剂 (PPIs) 或组胺-2 受体阻滞剂 (H2RBs) 常作为应激性溃疡预防药物用于患者。这些药物对死亡率的比较效果尚不清楚。 目的: 比较 PPIs 与 H2RBs 预防应激性溃疡的住院死亡率。 设计、地点和参与者: 2016年8月至 2019年1月在 5 个国家的 50 个 icu 进行的集群交叉随机临床试验。在入住 ICU 24 小时内需要有创机械通气的患者在医院进行 90 天的随访。 干预措施: 比较了两种应激性溃疡预防策略 (PPIs 优先使用与 H2RBs 优先使用)。每个 ICU 按随机顺序依次使用每种策略 6 个月; 25 个 ICUs 被随机分配到使用 PPIs 的序列,然后使用 H2RBs,25 个 ICUs 被随机分配到使用 H2RBs 的序列,然后使用 PPIs。(13 436 例患者按部位随机分配至 PPIs,13 392 按部位随机分配至 H2RBs)。 主要结局和措施: 主要结局是指数住院期间 90 天内的全因死亡率。次要结局是临床上重要的上消化道出血、艰难梭菌感染以及 ICU 和住院时间。 结果: 在 26 982 例随机患者中,154 例选择退出,26 828 例被分析 (平均 [SD] 年龄,58 [17.0] 岁; 9691 [36.1%] 为女性)。死亡分析纳入 26 771 例患者 (99.2%); 13 2459 例患者中的 415 例 (18.3%) 在 PPI 组中,90 天在医院死亡,H2RB 组 2333 例患者 (356) 中,17.5% 例在 90 天在医院死亡 (风险比, 1.05 [95% CI,1.00 ~ 1.10]; 绝对风险差异,0.93 个百分点 [95% CI,-0.01 ~ 1.88] 个百分点; p =  .054)。估计 4.1% 的由 ICU 站点随机分配到 PPIs 的患者实际上接受了 H2RBs,估计 20.1% 的由 ICU 站点随机分配到 H2RBs 的患者实际上接受了 PPIs。临床上重要的上消化道出血发生在 PPI 组的 1.3% 和 H2RB 组的 1.8% (风险比,0.73 [95% CI,0.57 ~ 0.92]; 绝对风险差异, -0.51 个百分点 [95% CI,-0.90 至-0.12 个百分点]; p =  。 009)。治疗组艰难梭菌感染率、 ICU 和住院时间无明显差异。PPI 组 1 例患者报告了 1 例不良事件 (过敏反应)。 结论和相关性: 在需要机械通气的 ICU 患者中,使用质子泵抑制剂 vs 组胺-2 受体阻滞剂的应激性溃疡预防策略导致医院死亡率为 18.3% vs 17.5%, 分别,没有达到显著性阈值的差异。然而,研究解释可能受到指定药物使用交叉的限制。 试用注册: anzctr.org.au 标识符: actrn12616000481471。

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影响因子:2.87
发表时间:2020-01-28
来源期刊:Bioscience reports
DOI:10.1042/BSR20192435
作者列表:["Yu H","Luo J","Ni Y","Hu Y","Liu D","Wang M","Liang B","Liang Z"]

METHODS::Backgroud Severe pneumonia is one of the most common causes for mechanical ventilation. We aimed to early identify severe pneumonia patients with high risk of extubation failure in order to improve prognosis. Methods From April 2014 to December 2015, medical records of intubated patients with severe pneumonia in intensive care unit were retrieved from database. Patients were divided into extubation success and failure groups, and multivariate logistic regressions were performed to identify independent predictors for extubation failure. Results A total of 125 eligible patients were included, of which 82 and 43 patients had extubation success and failure, respectively. APACHE II score (odds ration (OR) 1.141, 95% confident interval (CI) 1.022-1.273, P = 0.019, cutoff at 17.5), blood glucose (OR 1.122, 95%CI 1.008-1.249, P = 0.035, cutoff at 9.87mmol/L), dose of fentanyl (OR 3.010, 95%CI 1.100-8.237, P = 0.032, cutoff at 1.135mg/d), and the need for red blood cell (RBC) transfusion (OR 2.774, 95%CI 1.062-7.252, P = 0.037) were independent risk factors for extubation failure. Conclusions In patients with severe pneumonia, APACHE II score > 17.5, blood glucose > 9.87mmol/L, fentanyl usage > 1.135mg/d, and the need for RBC transfusion might be associated with higher risk of extubation failure.

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影响因子:3.86
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DOI:10.1016/j.resuscitation.2020.01.013
作者列表:["Lundin A","Karlsson T","Herlitz J","Lundgren P","Rylander C"]

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