第三代芳香化酶抑制剂(AI),以来曲唑为代表,阿那曲唑,和依西美坦,已被用作激素受体阳性的绝经后乳腺癌患者的标准一线辅助治疗。然而,它们在现实世界中的安全性尚未得到系统分析。我们使用美国食品和药物管理局不良事件报告系统(FAERS)来调查三个AI的不良事件(AE)概况,涵盖2004年第一季度至2023年第三季度。通过Weibull形状参数检验和Kaplan-Meier方法分析事件发生时间和累积发生率。分别。不相称性分析用于评估药物毒性风险。根据FAERS数据库,18,035、8242和7011报告列出了来曲唑,阿那曲唑,和依西美坦作为主要的可疑药物被提取,分别。与阿那曲唑相关的不良事件表现为最新发作(p<0.0001);同时,WSP测试表明,所有三个AI都具有早期故障类型特征。在首选术语级别,我们获得了95、59和42个与来曲唑相关的重要信号,阿那曲唑,和依西美坦,其中涉及18、13和15个系统器官类别,分别。三个AI均报告其最强的AE信号是触发手指。中性粒细胞减少症是来曲唑最常见的AE,而阿那曲唑和依西美坦的发生率最高的是关节痛。我们还发现间质性肺病,罕见但严重的AE,在所有三个AI中均显示出强信号强度。此外,来曲唑还与许多其他罕见但严重的血液学不良事件有关,呼吸,和肝脏系统,没有记录在说明书中。我们从FAERS数据库中分析第三代AI的安全预警信号,为临床安全合理用药提供参考。
The third-generation aromatase inhibitors (AIs), represented by letrozole, anastrozole, and exemestane, have been used as a standard first-line adjuvant therapy for postmenopausal breast cancer patients with positive hormone receptor. However, their safety in the real world has not been systematically analyzed. We used the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) to investigate adverse event (AE) profiles of the three AIs, covering the period from Q1 2004 to Q3 2023. The time-to-event onset profiles and cumulative incidence were analyzed by Weibull shape parameter test and Kaplan-Meier method, respectively. The disproportionality analysis was utilized to assess drug toxicity risk. Based on the FAERS database, 18,035, 8242, and 7011 reports listing letrozole, anastrozole, and exemestane as primary suspected drugs were extracted, respectively. AEs associated with anastrozole displayed the latest onset (p < 0.0001); meanwhile, WSP test showed that all three AIs had early failure-type profiles. At the preferred term level, we acquired 95, 59, and 42 significant signals associated with letrozole, anastrozole, and exemestane, which involved 18, 13, and 15 system organ classes, respectively. The three AIs all reported that their strongest AE signal was trigger finger. Neutropenia was the most frequent AE for letrozole, while the highest occurrences of anastrozole and exemestane were arthralgia. We also found that interstitial lung disease, a rare but serious AE, showed strong signal intensity in all three AIs. Additionally, letrozole was also associated with lots of other rare but serious AEs in hematologic, respiratory, and hepatic systems, which were not recorded in the instructions. Our analysis of safety warning signals of the third-generation AIs from the FAERS database provided reference for clinical safe and rational drug use.