Kanbayashi Yuko, Tomii Rio, Yamamoto Naru, Wakabayashi Haruka, Anzai Miku, Shimizu Tadashi, Uchida Mayako
Department of Education and Research Center for Clinical Pharmacy, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, Japan;
Department of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Japan.
In Vivo. 2025 Jan-Feb;39(1):360-366. doi: 10.21873/invivo.13836.
BACKGROUND/AIM: Despite the seriousness of lung adverse events (AEs) associated with sorafenib, comprehensive data are limited. This study was conducted to examine the disproportionality, times to onset, incidence rates, and outcomes of sorafenib-associated lung AEs, using the Japanese Adverse Drug Event Report database.
Data for the period between April 2004 and May 2023 were analyzed. Data on lung AEs were extracted, and the relative disproportionality of AEs was estimated using reporting odds ratios (RORs).
A total of 2,230,863 reports were analyzed, and 8,374 reports of AEs associated with sorafenib, including 381 lung AEs, were identified. Signals were detected for two lung AEs: metastases to the lung and tracheal hemorrhage. Fatal outcomes were observed for both AEs. Histograms of the median times to onset of the two detected lung AE signals showed that AEs occurred from 49 to 275 days after sorafenib administration. Weibull distributions showed that the incidences of these AEs occurred constantly throughout the exposure period (random failure type).
This study focused on lung AEs associated with sorafenib, highlighting serious outcomes such as lung metastases and tracheal hemorrhage. Continuous monitoring for these AEs is crucial from treatment initiation through the entire therapy course.
背景/目的：尽管与索拉非尼相关的肺部不良事件（AE）较为严重，但全面的数据有限。本研究利用日本药品不良事件报告数据库，对索拉非尼相关肺部AE的不成比例性、发病时间、发病率及转归进行研究。
分析2004年4月至2023年5月期间的数据。提取肺部AE的数据，并使用报告比值比（ROR）估计AE的相对不成比例性。
共分析了2,230,863份报告，确定了8374份与索拉非尼相关的AE报告，其中包括381份肺部AE报告。检测到两种肺部AE的信号：肺转移和气管出血。两种AE均观察到致命结局。所检测到的两种肺部AE信号的中位发病时间直方图显示，AE发生在索拉非尼给药后49至275天。威布尔分布显示，这些AE的发病率在整个暴露期持续发生（随机失效类型）。
本研究聚焦于与索拉非尼相关的肺部AE，突出了肺转移和气管出血等严重结局。从治疗开始到整个治疗过程，持续监测这些AE至关重要。
