Table1_Risk factors for drug-related acute pancreatitis: an analysis of the FDA adverse event reporting system (FAERS).DOCX

Objective: While several drugs have been linked to acute pancreatitis (AP), the AP-related risk of most drugs remains unclear. This study investigated the risk factors for drug-induced AP by analyzing a large dataset from the FDA Adverse Event Reporting System (FAERS).
Methods: The reporting odds ratios (ROR) were used to assess the reports of drug-induced AP from the first quarter of 2004 to the second quarter of 2022. Single-factor, LASSO, and multi-factor regression analysis were performed to explore drug-related AP-related risk factors. Bonferroni correction was applied for the multiple comparisons performed.
Results: A total of 264 drugs associated with AP, including antineoplastic drugs (35/264), antidiabetic drugs (28/264), antibacterial drugs (24/264), immunomodulatory drugs (11/264), antipsychotic drugs (6/264), and other drugs (160/264) were retrieved. Multi-factor analysis showed that males, age 41–54 years old, and 36 drugs, including Tigecycline, were risk factors for drug-related AP. The median time to drug-related AP onset was 31 days (interquartile range [IQR] 7–102 days) and about 75% of adverse events occurred within 100 days.
Conclusion: These findings may help clinicians to identify drug-related AP at the early stage and can be used to inform future studies of drug-related AP pathogenesis.

研究目标：尽管已有多种药物与急性胰腺炎（acute pancreatitis, AP）相关联，但大多数药物的AP相关风险仍不明确。本研究通过分析来自美国食品药品监督管理局不良事件报告系统（FDA Adverse Event Reporting System, FAERS）的大型数据集，探究药物诱导性AP的危险因素。
研究方法：本研究采用报告比值比（reporting odds ratios, ROR），对2004年第一季度至2022年第二季度期间的药物诱导性AP报告进行评估。通过单因素、套索（LASSO）回归及多因素回归分析，探索与药物相关的AP危险因素，并采用邦费罗尼校正（Bonferroni correction）处理多重比较问题。
研究结果：共检索到264种与AP相关的药物，其中包括抗肿瘤药物35种（35/264）、抗糖尿病药物28种（28/264）、抗菌药物24种（24/264）、免疫调节药物11种（11/264）、抗精神病药物6种（6/264）以及其他药物160种（160/264）。多因素分析结果显示，男性、41~54岁年龄段以及包括替加环素（Tigecycline）在内的36种药物为药物相关性AP的危险因素。药物相关性AP的中位发病时间为31天（四分位数间距[IQR] 7~102天），约75%的不良事件发生于用药后100天内。
研究结论：本研究结果有助于临床医生早期识别药物相关性AP，可为未来药物相关性AP发病机制的相关研究提供参考依据。