Yang Yixuan, Xie Hanzhang, Liu Shuhan, Jia Ying, Cui Bingnan, Xiao Zhanshuo
Department of Dermatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Beijing University of Chinese Medicine, Beijing, China.
Front Med (Lausanne). 2025 Jan 23;12:1521697. doi: 10.3389/fmed.2025.1521697. eCollection 2025.
Linear IgA bullous dermatosis (LABD) is a rare autoimmune blistering disease. The induction of LABD by medications is a critical issue, with previous studies highlighting the link between specific drugs and the onset of LABD. This study aims to assess the reported associations between LABD and numerous available medications using the FDA adverse event reporting system (FAERS).
The study encompassed FAERS reports spanning the years 2004-2024. Medical Dictionary for Regulatory Activities (MedDRA) was used to identify cases of LABD. The Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical Bayes Geometric Mean were calculated to assess the reported associations between available drugs and LABD. A significant statistical association was considered when a drug signal met the criteria of all four algorithms.
In the FAERS database analysis, we identified 1,394 adverse event (AE) reports associated with LABD. The gender distribution of reports was relatively balanced, with the highest proportion in the 66-85 age group. The United States had the highest number of reports. Vancomycin and Amoxicillin were the most frequently reported drugs, with 559 and 58 reports, respectively. Through disproportionality analysis, we identified 34 drugs significantly associated with AEs of LABD, including antibiotics, antifungal medications, analgesics, nonsteroidal anti-inflammatory drugs, cardiovascular medications, and calcium channel blockers, among which the antibiotic Vancomycin showed the highest association. These results emphasize the need for further clinical attention to the safety of specific medications.
This is the first real-world study using the FAERS database to investigate drug-induced LABD. LABD is closely associated with antibiotic medications. Close monitoring of patients is required when these medications are used clinically to promptly detect and manage potential AEs such as LABD.
线状IgA大疱性皮肤病（LABD）是一种罕见的自身免疫性大疱性疾病。药物诱发LABD是一个关键问题，先前的研究强调了特定药物与LABD发病之间的联系。本研究旨在使用美国食品药品监督管理局不良事件报告系统（FAERS）评估LABD与众多现有药物之间已报道的关联。
该研究涵盖了2004年至2024年的FAERS报告。使用医学监管活动医学词典（MedDRA）来识别LABD病例。计算报告比值比、比例报告比、贝叶斯置信传播神经网络和经验贝叶斯几何均值，以评估现有药物与LABD之间已报道的关联。当药物信号符合所有四种算法的标准时，则认为存在显著的统计学关联。
在FAERS数据库分析中，我们确定了1394份与LABD相关的不良事件（AE）报告。报告的性别分布相对均衡，66 - 85岁年龄组的比例最高。美国的报告数量最多。万古霉素和阿莫西林是报告频率最高的药物，分别有559份和58份报告。通过不成比例分析，我们确定了34种与LABD不良事件显著相关的药物，包括抗生素、抗真菌药物、镇痛药、非甾体抗炎药、心血管药物和钙通道阻滞剂，其中抗生素万古霉素的关联性最高。这些结果强调了临床需要进一步关注特定药物的安全性。
这是第一项使用FAERS数据库调查药物诱发LABD的真实世界研究。LABD与抗生素密切相关。临床使用这些药物时需要密切监测患者，以便及时发现和处理潜在的不良事件，如LABD。
