近日，瑞典卡罗林斯卡学院Robin Hofmann团队研究了急性心肌梗死后幽门螺杆菌筛查能否改善患者上消化道出血。这一研究成果于2025年9月2日发表在《美国医学会杂志》上。

上消化道出血在心肌梗死后很常见。为了确定心肌梗死住院期间常规筛查幽门螺杆菌感染是否能减少出血事件并改善临床预后。研究组进行了一项全国性、开放标签、2期、2序列、聚类随机、交叉临床试验，使用临床登记进行研究人群定义，并将数据收集与瑞典国家健康数据登记合并。

从2021年11月17日至2024年1月17日，研究组将35家瑞典医院分为18组，随机分为1年的序列，对所有急性心肌梗死患者进行常规幽门螺杆菌筛查，然后进行2个月的洗脱期，然后再进行1年的常规护理，反之亦然。患者随访至2025年1月17日。在筛查期间所有心肌梗死住院患者的标准护理中常规加入尿素呼气试验筛查幽门螺杆菌。主要结局为上消化道出血，在意向治疗人群中采用负二项模型分析。

共随访了18466名心肌梗死患者（中位年龄71岁[IQR，61-79]，男性13138名[71%]）：筛查期为9245名，非筛查期为9221名。入院时，2284名筛查期患者和2275名非筛查期患者（均为24.7%）报告使用了质子泵抑制剂。在筛查期间，6480名患者（70%）接受了检测，其中1532名（23.6%）幽门螺杆菌检测呈阳性。经过1.9年的中位随访，筛查组299名患者（发病率，每1000人年16.8起事件；3年的累积风险，4.1%）和常规护理组336名患者（发生率，每千人年19.2起事件，3年的累计风险，4.6%）经历了上消化道出血的主要终点（比率[RR]，0.90；95%CI，0.77-1.05；P=0.18）。预定义的非多重调整亚组分析显示异质性干预效果；无贫血（RR, 0.98; 95% CI, 0.80-1.21）、轻度贫血（RR, 0.64; 95% CI, 0.42-0.98）和中度至重度贫血（RR, 0.44; 95% CI, 0.23-0.87；相互作用P = 0.03）。

研究结果表明，在未入组的急性心肌梗死患者中，常规幽门螺杆菌筛查并没有显著降低上消化道出血的风险。

附：英文原文

Title: Helicobacter pylori Screening After Acute Myocardial Infarction: The Cluster Randomized Crossover HELP-MI SWEDEHEART Trial

Author: Robin Hofmann, Stefan James, Martin O. Sundqvist, Jonatan Wrme, Oskar Angers, Joakim Alfredsson, David Erlinge, Gabriel Arefalk, Gran Arstad, Simon Blomberg, Ole Frbert, Kristina Hambraeus, Per M. Hellstrm, Jrg Lauermann, Matthias Lidin, Lars Lindhagen, Georgios Mourtzinis, Carolina Schoede, Erik Thunstrm, Birgitta Voldberg, Henrik Wagner, Ollie stlund, Tomas Jernberg, Magnus Bck

Issue&Volume: 2025-09-01

Abstract:

Importance  Upper gastrointestinal bleeding is common after myocardial infarction.

Objective  To determine whether routine screening for Helicobacter pylori infection during hospitalization for myocardial infarction reduces bleeding events and improves clinical outcomes.

Design, Setting, and Participants  A nationwide, open-label, 2-period, 2-sequence, cluster randomized, crossover clinical trial using a clinical registry for study population definition and data collection merged with national Swedish health data registries. From November 17, 2021, through January 17, 2024, thirty-five Swedish hospitals grouped into 18 clusters were randomized to a sequence of 1 year with routine H pylori screening of all patients with acute myocardial infarction followed by a washout period of 2 months before crossing over to 1 year with usual care or vice versa. Patients were followed up until January 17, 2025.

Intervention  Routine addition of H pylori screening by urea breath test to standard care in all patients hospitalized for myocardial infarction during the screening periods.

Main Outcome and Measure  Upper gastrointestinal bleeding, analyzed by a negative binomial model in the intention-to-treat population.

Results  A total of 18466 patients (median age, 71 years [IQR, 61-79], 13138 males [71%]) with myocardial infarction were followed up: 9245 during the screening periods and 9221 during the nonscreening periods. At admission, 2284 during the screening periods and 2275 during the nonscreening periods (both 24.7%) reported proton pump inhibitor use. During screening periods, 6480 patients (70%) had undergone testing, of those 1532 (23.6%) tested positive for H pylori. After a median follow-up of 1.9 years, 299 patients in the screening group (incidence rate, 16.8 events per 1000 person-years; cumulative hazard at 3 years, 4.1%) and 336 in the usual care group (incidence rate, 19.2 events per 1000 person-years; cumulative hazard at 3 years, 4.6%) experienced the primary end point of upper gastrointestinal bleeding (rate ratio [RR], 0.90; 95% CI, 0.77-1.05; P=.18). Predefined nonmultiplicity adjusted subgroup analyses showed a heterogeneous intervention effect; for no anemia (RR, 0.98; 95% CI, 0.80-1.21), mild anemia (RR, 0.64; 95% CI, 0.42-0.98), and moderate to severe anemia (RR, 0.44; 95% CI, 0.23-0.87; P for interaction=.03).

Conclusions and Relevance  Among unselected patients with acute myocardial infarction, routine H pylori screening did not significantly reduce the risk of upper gastrointestinal bleeding.

DOI: 10.1001/jama.2025.15047

Source: https://jamanetwork.com/journals/jama/fullarticle/2838493