Zhong Zilan, Liu Manting, Zhong Qian, Zhou Miao, Di Xingwei
Shenzhen Clinical Medical College, Guangzhou University of Chinese Medicine, Shenzhen, China.
Clifford Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
Braz J Med Biol Res. 2025 Aug 22;58:e14566. doi: 10.1590/1414-431X2025e14566. eCollection 2025.
This study aimed to systematically evaluate the risk of drug-induced pulmonary edema (DIPE) using the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. This retrospective pharmacovigilance study utilized FAERS data from the first quarter of 2004 to the second quarter of 2024. We identified drugs with at least 10 reported DIPE cases as primary suspects (PS). The DIPE signals were assessed using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM). Multivariate logistic regression was employed to control for confounding factors, and the timing of DIPE onset was statistically analyzed. Out of 173 target drugs, 37 were identified with DIPE risk. The top five drugs were naloxone, dasatinib, nifedipine, anti-thymocyte globulin, and pioglitazone. Multivariate logistic regression indicated that all except pioglitazone were independent risk factors for DIPE. The onset time of DIPE varied by age and gender for some drugs. This study is the first to identify the DIPE risk systematically associated with multiple drugs. It highlights the need for clinicians and pharmacists to be aware of these high-risk drugs and to monitor high-risk populations closely to ensure medication safety.
本研究旨在利用美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库，系统评估药物性肺水肿（DIPE）的风险。这项回顾性药物警戒研究使用了2004年第一季度至2024年第二季度的FAERS数据。我们将报告的DIPE病例至少有10例的药物确定为主要怀疑药物（PS）。使用四种方法评估DIPE信号：报告比值比（ROR）、比例报告比值比（PRR）、贝叶斯置信传播神经网络（BCPNN）和经验贝叶斯几何均值（EBGM）。采用多因素逻辑回归控制混杂因素，并对DIPE发病时间进行统计学分析。在173种目标药物中，有37种被确定存在DIPE风险。排名前五的药物是纳洛酮、达沙替尼、硝苯地平、抗胸腺细胞球蛋白和吡格列酮。多因素逻辑回归表明，除吡格列酮外，所有药物都是DIPE的独立危险因素。某些药物的DIPE发病时间因年龄和性别而异。本研究首次系统地确定了与多种药物相关的DIPE风险。它强调临床医生和药剂师需要了解这些高风险药物，并密切监测高风险人群，以确保用药安全。
