与仅使用非甾体抗炎药（NSAID）的使用者相比，同时使用NSAID和质子泵抑制剂的使用者发生下消化道出血的风险：一项通用数据模型分析。

Risk of Lower Gastrointestinal Bleeding in Nonsteroidal Anti-inflammatory Drug (NSAID) and Proton Pump Inhibitor Users Compared with NSAID-Only Users: A Common Data Model Analysis.

作者信息

Lee Moonhyung, Kim Myoungsuk, Cha Jae Myung

机构信息

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.

出版信息

Gut Liver. 2025 Mar 15;19(2):243-252. doi: 10.5009/gnl240247. Epub 2025 Jan 3.

DOI:10.5009/gnl240247

PMID:39748650

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11907254/

Abstract

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

摘要

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。

方法

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。

结果

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）。