Deng Ying-Han, Jiang Meiting, Chen Yun, Chen Hong-Bin
Department of Gastroenterology, Sanming First Hospital Affiliated to Fujian Medical University, Sanming, China.
Department of Gastroenterology, Sanming First Hospital Affiliated to Fujian Medical University, Sanming 365000, China.
Ther Adv Drug Saf. 2025 May 6;16:20420986251318848. doi: 10.1177/20420986251318848. eCollection 2025.
Currently, the factors influencing small bowel bleeding caused by nonsteroidal anti-inflammatory drugs (NSAIDs) remain unclear.
This study aimed to assess NSAID-associated small bowel bleeding and evaluate the impact of other drugs on it through a pharmacovigilance study, thereby providing valuable insights for clinical practice.
Data on NSAID-associated small bowel bleeding were retrospectively extracted from two public adverse drug reaction databases-the Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) and the Japan Pharmaceuticals and Medical Devices Agency's Adverse Drug Event Reporting (JADER)-from 2004 to 2023 for further analysis.
The reporting odds ratio (ROR), a pharmacovigilance technique, was employed to identify signals of adverse reactions, and the Chi-square test was utilized to assess differences between groups.
Multiple NSAIDs associated with small bowel bleeding were identified in both databases. In the drug combination analysis, no significant differences in the risk of small bowel bleeding were found between NSAIDs combined with proton pump inhibitors (PPIs) and NSAIDs alone in FAERS (all > 0.05). Decreasing risks were found when multiple NSAIDs were combined with rebamipide or probiotics compared to NSAIDs alone in JADER ( < 0.05 and ROR < 1). In subgroup analyses of age and sex, older adults and males who used aspirin showed higher risk signals in both databases (all < 0.05 and ROR > 1).
PPIs did not show a significant impact on NSAIDs-associated small bowel bleeding, while rebamipide and probiotics may exhibited a preventive effect against NSAIDs-associated small bowel bleeding. Older adults and males constituted risk factors for aspirin-associated small bowel bleeding.
目前，非甾体抗炎药（NSAIDs）所致小肠出血的影响因素尚不清楚。
本研究旨在通过药物警戒研究评估NSAIDs相关小肠出血情况，并评估其他药物对其的影响，从而为临床实践提供有价值的见解。
从两个公共药物不良反应数据库——美国食品药品监督管理局（FDA）的不良事件报告系统（FAERS）和日本药品和医疗器械管理局的药品不良事件报告（JADER）中，回顾性提取2004年至2023年期间与NSAIDs相关的小肠出血数据，进行进一步分析。
采用药物警戒技术报告比值比（ROR）来识别不良反应信号，并使用卡方检验评估组间差异。
两个数据库中均识别出多种与小肠出血相关的NSAIDs。在药物联合分析中，FAERS中NSAIDs联合质子泵抑制剂（PPIs）与单独使用NSAIDs相比，小肠出血风险无显著差异（均>0.05）。在JADER中，与单独使用NSAIDs相比，多种NSAIDs联合瑞巴派特或益生菌时出血风险降低（<0.05且ROR<1）。在年龄和性别的亚组分析中，两个数据库中使用阿司匹林的老年人和男性显示出较高的风险信号（均<0.05且ROR>1）。
PPIs对NSAIDs相关小肠出血未显示出显著影响，而瑞巴派特和益生菌可能对NSAIDs相关小肠出血具有预防作用。老年人和男性是阿司匹林相关小肠出血的危险因素。
