Department of Pharmacy, Ningbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University, Ningbo, 315010, Zhejiang, China.
Department of Nursing, Ningbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University, Ningbo, 315010, Zhejiang, China.
Int J Clin Pharm. 2024 Dec;46(6):1381-1390. doi: 10.1007/s11096-024-01778-y. Epub 2024 Jul 23.
Proton pump inhibitors (PPIs) are commonly prescribed for treating upper gastrointestinal hemorrhage, eradicating Helicobacter pylori, and stress ulcer prophylaxis, among other digestive system diseases. Recent case reports provided limited evidence of a correlation between PPIs and drug reactions with eosinophilia and systemic symptoms (DRESS). However, there is currently no established association between PPIs and DRESS.
This research aimed to identify the associations between PPIs and DRESS using the US Food and Drug Administration Adverse Events Reporting System (FAERS) database.
A retrospective investigation of DRESS associated with six PPIs used FAERS data from Q1 2004 to Q3 2023. Data mining algorithms were used to identify adverse events in the FAERS database that met the following criteria: (1) proportional reporting ratio (PRR) ≥ 2; (2) reporting odds ratio (ROR) > 1; (3) 95% confidence interval (CI) of ROR > 1; (4) Chi-square (χ) ≥ 4 and case count ≥ 3.
There were 495 reports of PPI-related DRESS, including pantoprazole (174, 35.2%), omeprazole (103, 20.8%), lansoprazole (103, 20.8%), esomeprazole (101, 20.4%), rabeprazole (8, 1.6%), and dexlansoprazole (6, 1.2%). The results indicated a significant association of three PPIs (pantoprazole, omeprazole, and lansoprazole) with DRESS. The sensitivity analysis demonstrated that only pantoprazole remained significantly associated with DRESS after 10 concomitant drugs had been removed (ROR: 3.00, PRR: 2.99, and information component [IC]: 1.57).
This study identified the signals suggesting a potential association between DRESS and six PPIs. However, more investigation of epidemiological data is required to validate of these conclusions.
质子泵抑制剂 (PPI) 常用于治疗上消化道出血、根除幽门螺杆菌和应激性溃疡预防等消化系统疾病。最近的病例报告提供的有限证据表明，PPI 与药物反应伴嗜酸性粒细胞增多和全身性症状 (DRESS) 之间存在相关性。然而，目前尚未确定 PPI 与 DRESS 之间存在关联。
本研究旨在使用美国食品和药物管理局不良事件报告系统 (FAERS) 数据库确定 PPI 与 DRESS 之间的关联。
对 2004 年第一季度至 2023 年第三季度 FAERS 数据中与六种 PPI 相关的 DRESS 进行回顾性调查。使用数据挖掘算法识别 FAERS 数据库中符合以下标准的不良事件：(1) 比例报告比 (PRR)≥2；(2) 报告比值比 (ROR) > 1；(3) ROR 的 95%置信区间 (CI) > 1；(4) χ 平方 (χ)≥4 且病例数≥3。
共有 495 例 PPI 相关 DRESS 报告，其中泮托拉唑 (174 例，35.2%)、奥美拉唑 (103 例，20.8%)、兰索拉唑 (103 例，20.8%)、艾司奥美拉唑 (101 例，20.4%)、雷贝拉唑 (8 例，1.6%) 和地塞米拉唑 (6 例，1.2%)。结果表明，三种 PPI（泮托拉唑、奥美拉唑和兰索拉唑）与 DRESS 显著相关。敏感性分析表明，在去除 10 种伴随药物后，只有泮托拉唑与 DRESS 仍显著相关 (ROR：3.00，PRR：2.99，信息成分 [IC]：1.57)。
本研究确定了提示 DRESS 与六种 PPI 之间存在潜在关联的信号。然而，需要进一步研究流行病学数据来验证这些结论。
