服用阿司匹林的患者的消化性溃疡与幽门螺杆菌感染有关。我们的目的是研究根除幽门螺杆菌是否能防止阿斯匹林相关的溃疡出血。

共有30166例患者进行了幽门螺杆菌呼吸检测，5367例结果为阳性，5352例随机分配接受主动根除(n=2677)或安慰剂(n=2675)，与对照组相比，主动根除组在前2·5年的随访中主要结局的发生率显著降低(确诊或可能消化性溃疡出血6次，发生率0.92 [95% CI 0.41 - 0.02] / 1000人-年vs 17次，发生率2.61[1.62 -4·19]/ 1000人-年;风险比[HR] 0.35 [95% CI 0.14 - 0.89];p = 0·028)。

在我们的试验中溃疡出血的低背景率，以及根除幽门螺杆菌和抑制酸作为预防的可用性，也应该为评估阿司匹林的风险和收益的平衡提供信息，并可能支持更自由地使用该药物。在重新评估阿司匹林在心血管疾病中的作用时，应考虑到这些信息，并可能扩展到预防结直肠癌和其他癌症。

Abstract

Background: Peptic ulcers in patients receiving aspirin are associated with Helicobacter pylori infection. We aimed to investigate whether H pylori eradication would protect against aspirin-associated ulcer bleeding.

Methods: We conducted a randomised, double-blind, placebo-controlled trial (Helicobacter Eradication Aspirin Trial [HEAT]) at 1208 primary care centres in the UK, using routinely collected clinical data. Eligible patients were aged 60 years or older who were receiving aspirin at a daily dose of 325 mg or less (with four or more 28-day prescriptions in the past year) and had a positive C13 urea breath test for H pylori at screening. Patients receiving ulcerogenic or gastroprotective medication were excluded. Participants were randomly assigned (1:1) to receive either a combination of oral clarithromycin 500 mg, metronidazole 400 mg, and lansoprazole 30 mg (active eradication), or oral placebo (control), twice daily for 1 week. Participants, their general practitioners and health-care providers, and the research nurses, trial team, adjudication committee, and analysis team were all masked to group allocation throughout the trial. Follow-up was by scrutiny of electronic data in primary and secondary care. The primary outcome was time to hospitalisation or death due to definite or probable peptic ulcer bleeding, and was analysed by Cox proportional hazards methods in the intention-to-treat population. This trial is registered with EudraCT, 2011-003425-96.

Findings: Between Sept 14, 2012, and Nov 22, 2017, 30 166 patients had breath testing for H pylori, 5367 had a positive result, and 5352 were randomly assigned to receive active eradication (n=2677) or placebo (n=2675) and were followed up for a median of 5·0 years (IQR 3·9-6·4). Analysis of the primary outcome showed a significant departure from proportional hazards assumptions (p=0·0068), requiring analysis over separate time periods. There was a significant reduction in incidence of the primary outcome in the active eradication group in the first 2·5 years of follow-up compared with the control group (six episodes adjudicated as definite or probable peptic ulcer bleeds, rate 0·92 [95% CI 0·41-2·04] per 1000 person-years vs 17 episodes, rate 2·61 [1·62-4·19] per 1000 person-years; hazard ratio [HR] 0·35 [95% CI 0·14-0·89]; p=0·028). This advantage remained significant after adjusting for the competing risk of death (p=0·028) but was lost with longer follow-up (HR 1·31 [95% CI 0·55-3·11] in the period after the first 2·5 years; p=0·54). Reports of adverse events were actively solicited; taste disturbance was the most common event (787 patients).

Interpretation: H pylori eradication protects against aspirin-associated peptic ulcer bleeding, but this might not be sustained in the long term.

文章连接：

www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01843-8/fulltext

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