Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.
Department of Clinical Pharmacology and Pharmacy, University of Southern Denmark, Odense, Denmark.
Basic Clin Pharmacol Toxicol. 2020 May;126(5):437-443. doi: 10.1111/bcpt.13370. Epub 2019 Dec 19.
Upper gastrointestinal bleeding is a feared complication of using non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin. Studies predicting the incidence rate for individuals with a given set of characteristics are lacking. The aim of this study was to develop a risk model to predict the incidence rate of upper gastrointestinal bleeding (UGIB) in users of aspirin/NSAID based on presence of well-defined risk factors for the individual patient.
The model was developed from data from a case-control study, sampled from a well-defined source population, residents of the Funen County 1995-2006. All cases and controls were characterized in terms of factors known to affect the risk of UGIB. By using census data, we rescaled the control group, so their composition accurately reflected age and sex distribution of the source population. Only persons using NSAIDs or/and aspirin and no PPI were included in the analysis. As reference group, we chose 80- to 89-year-old women with no ulcer history, using NSAID, but neither aspirin, other platelet inhibitors, vitamin K antagonists, selective serotonin reuptake inhibitors nor corticosteroids.
We identified 1388 cases among non-users of PPIs. We found a modelled baseline incidence rate of 10.7 per 1000 person-years for the reference group. The strongest associations were found for ADP inhibitors (OR 5.80), followed by anticoagulants treatment (OR 2.62) and prior ulcer (OR 2.68). The model performed well in terms of calibration and discriminatory power.
This study is the first to describe a model, which estimates the incidence rate of UGIB for patients using aspirin/NSAID, based on the specific combination of risk factors. Risk of upper gastrointestinal bleeding for a given patient can be accurately estimated using this model.
上消化道出血是使用非甾体抗炎药(NSAIDs)或阿司匹林的可怕并发症。缺乏预测具有特定特征的个体发生率的研究。本研究旨在建立一个风险模型,以预测基于个体患者明确危险因素的阿司匹林/NSAID 使用者上消化道出血(UGIB)的发生率。
该模型是从病例对照研究的数据中开发的,该研究是从一个明确界定的来源人群(1995-2006 年的菲英郡居民)中抽取的样本。所有病例和对照均根据已知影响 UGIB 风险的因素进行了特征描述。通过使用人口普查数据,我们对对照组进行了重新缩放,使其组成准确反映了来源人群的年龄和性别分布。仅包括使用 NSAIDs 或/和阿司匹林且未使用 PPI 的患者。作为参考组,我们选择了一位 80-89 岁、无溃疡史、使用 NSAID、但未使用阿司匹林、其他血小板抑制剂、维生素 K 拮抗剂、选择性 5-羟色胺再摄取抑制剂或皮质类固醇的女性。
我们在未使用 PPI 的患者中发现了 1388 例病例。我们发现参考组的模型基线发生率为每 1000 人年 10.7 例。最强的关联是 ADP 抑制剂(OR 5.80),其次是抗凝剂治疗(OR 2.62)和既往溃疡(OR 2.68)。该模型在校准和区分能力方面表现良好。
本研究首次描述了一种模型,该模型基于特定的危险因素组合,估计使用阿司匹林/NSAID 的患者的 UGIB 发生率。可以使用该模型准确估计给定患者的上消化道出血风险。