基于FAERS数据库的达罗他胺不良反应信号挖掘与分析

目的：挖掘达罗他胺相关的不良反应风险信号，为临床安全用药提供参考。方法：利用报告比值比法（ROR）对美国FDA不良反应报告系统（FAERS）中2019年第三季度至2022年第四季度以达罗他胺为首要怀疑药物的不良反应进行挖掘，检测阈值为报告数 ≥ 3且ROR的95%置信区间下限 ＞ 1的不良反应。结果及结论：共筛选出以达罗他胺为首要怀疑药物的不良反应报告1376份，去除非药品不良反应后为1013份，涉及患者589例，检测出风险信号40个，涉及16个系统器官，主要集中在全身性疾病及给药部位各种反应、胃肠系统疾病、皮肤及皮下组织类疾病、各类检查及各类神经系统疾病。达罗他胺的不良反应最常出现在服药的第1个月。挖掘出药品说明书未提及的信号21个，具体包括横纹肌溶解、谵妄、男性乳腺发育、周围神经病变和水肿等。

Data Mining and Analysis of Adverse Events of Darolutamide Based on FAERS Database

Objective: To explore the risk signals of adverse reactions associated with darolutamide and provide reference for clinical safe drug use. Methods: The reported odds ratio (ROR) method of the proportional imbalance method was used to mine adverse reactions in the FDA Adverse Reaction Reporting System (FAERS) of the United States from the third quarter of 2019 to the fourth quarter of 2022 with darolutamide as the primary suspect drug. The detection threshold was for adverse reactions with a reported number ≥ 3 and a lower limit of the 95% confidence interval of the ROR greater than 1. Results & Conclusion: A total of 1376 adverse reaction reports with darolutamide as the primary suspected drug were screened, and after removing non drug adverse reactions, 1013 reports of darolutamide adverse reactions were obtained, involving 589 patients. Forty risk signals were detected, involving 16 systemic organs. The adverse reaction signals mainly focused on systemic diseases and various reactions at the administration sites, gastrointestinal system diseases, skin and subcutaneous tissue diseases, various examinations and various nervous system diseases. The most common adverse reactions of darolutamide occurred in the first month of medication. Twenty-one signals not mentioned in the medication package inserts were found, including rhabdomyolysis, delirium, gynecomastia, peripheral neuropathy and edema.