Lee Moonhyung, Kim Myoungsuk, Cha Jae Myung
Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, School of Medicine, Kyung Hee University, Seoul, Korea.
Department of Healthcare Big-Data Center, Research Institute of Clinical Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
Gut Liver. 2025 Mar 15;19(2):243-252. doi: 10.5009/gnl240247. Epub 2025 Jan 3.
BACKGROUND/AIMS: Recent studies have shown an increased risk of lower gastrointestinal bleeding in patients who use both nonsteroidal anti-inflammatory drugs (NSAIDs) and proton pump inhibitors (PPIs). We analyzed the risk of lower gastrointestinal bleeding and compared this risk between NSAID+PPI users and NSAID-only users.
In this retrospective, observational study, data from five hospitals were analyzed using a common data model to determine the risk of lower gastrointestinal bleeding and compare this risk between NSAID+PPI users (target cohort) and NSAID-only users (comparative cohort). Cox proportional hazard models and the Kaplan-Meier estimations were employed after extensive propensity score matching.
Among 24,530 individuals in the target cohort and 57,264 in the comparative cohort, 8,728 propensity score-matched pairs were analyzed. The risk of lower gastrointestinal bleeding was significantly higher in NSAID+PPI users than in NSAID-only users (hazard ratio [HR], 2.843; 95% confidence interval [CI], 1.998 to 4.044; p<0.001). Similar findings were also noted in elderly patients >65 years (HR, 2.737), males (HR, 2.963), and females (HR, 3.221). However, the risk of lower gastrointestinal bleeding was comparable between NSAID+mucoprotective agent users and NSAID-only users (HR, 2.057; 95% CI, 0.714 to 5.924; p=0.172).
The risk of lower gastrointestinal bleeding was higher in NSAID+PPI users than in NSAID-only users. However, the risk of lower gastrointestinal bleeding was comparable between NSAID+mucoprotective agent users and NSAID-only users.
背景/目的：近期研究表明，同时使用非甾体抗炎药（NSAIDs）和质子泵抑制剂（PPIs）的患者发生下消化道出血的风险增加。我们分析了下消化道出血的风险，并比较了NSAID+PPI使用者与仅使用NSAID者之间的这种风险。
在这项回顾性观察研究中，使用通用数据模型分析了五家医院的数据，以确定下消化道出血的风险，并比较NSAID+PPI使用者（目标队列）和仅使用NSAID者（对照队列）之间的这种风险。在进行广泛的倾向评分匹配后，采用Cox比例风险模型和Kaplan-Meier估计法。
在目标队列的24,530名个体和对照队列的57,264名个体中，分析了8,728对倾向评分匹配的个体。NSAID+PPI使用者发生下消化道出血的风险显著高于仅使用NSAID者（风险比[HR]，2.843；95%置信区间[CI]，1.998至4.044；p<0.001）。在65岁以上的老年患者（HR，2.737）、男性（HR，2.963）和女性（HR，3.221）中也观察到了类似的结果。然而，NSAID+黏膜保护剂使用者与仅使用NSAID者之间下消化道出血的风险相当（HR，2.057；95%CI，0.714至5.924；p=0.172）。
NSAID+PPI使用者发生下消化道出血的风险高于仅使用NSAID者。然而，NSAID+黏膜保护剂使用者与仅使用NSAID者之间下消化道出血的风险相当。
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