Zou Wenbin, Yang Han, Xi Yu, Zeng Chenxi, Chen Wei, Fu Xiangning
Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei Province, 430000, China.
Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei Province, 430000, China.
Heliyon. 2024 Sep 6;10(17):e37543. doi: 10.1016/j.heliyon.2024.e37543. eCollection 2024 Sep 15.
This study aimed to analyze the FAERS database to identify adverse event associated with sunitinib to offer valuable insights for the judicious utilization of medication in clinical settings.
Various disproportionality analysis techniques, such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPN), and multi-gamma Poisson shrinkage (MGPS), were employed to analyze adverse drug reaction (ADR) reports pertaining to sunitinib in the FAERS database from its market introduction up to the first quarter of 2023. Subsequently, a secondary screening process was conducted to identify reliable positive signals.
The analysis of sunitinib adverse event signals at the system-organ classification level encompassed 27 organ systems, with gastrointestinal and endocrine disorders emerging as the predominant SOCs. A total of 237 significant adverse events meeting all four algorithms were detected. Notably, this study revealed previously unreported adverse events, including pleural effusion and ascites, while potential adrenal toxicity-related adverse events, highlighted in the drug's specification, were not identified in this analysis. The study examined the relationship between the duration of sunitinib dosing and the onset of adverse events, revealing a median onset of 48 days (IQR, 15-160 days). The findings indicated that a majority of adverse events manifested early in the dosing period, with tumor progression, disease progression, and mortality becoming more prevalent after one year of treatment.
In the clinical utilization of sunitinib, vigilant monitoring of potential adverse reactions is imperative during the initial phase of drug administration. In addition to the documented adverse reactions outlined in the drug specification, healthcare providers should remain attentive to potential adverse reactions such as pleural effusion, ascites, and tumor development.
本研究旨在分析美国食品药品监督管理局不良事件报告系统（FAERS）数据库，以确定与舒尼替尼相关的不良事件，为临床合理用药提供有价值的见解。
采用多种不成比例分析技术，如报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPN）和多伽马泊松收缩法（MGPS），分析FAERS数据库中从舒尼替尼上市至2023年第一季度期间与舒尼替尼相关的药物不良反应（ADR）报告。随后，进行二次筛选以识别可靠的阳性信号。
在系统器官分类水平上对舒尼替尼不良事件信号的分析涵盖27个器官系统，其中胃肠道和内分泌紊乱是主要的系统器官分类。共检测到237例符合所有四种算法的严重不良事件。值得注意的是本研究发现了先前未报告的不良事件，包括胸腔积液和腹水，而该药物说明书中强调的潜在肾上腺毒性相关不良事件在本分析中未被识别。该研究检查了舒尼替尼给药持续时间与不良事件发生之间的关系，发现中位发病时间为48天（四分位间距，15 - 160天）。研究结果表明，大多数不良事件在给药期早期出现，肿瘤进展、疾病进展和死亡率在治疗一年后更为普遍。
在舒尼替尼的临床应用中，给药初期必须密切监测潜在的不良反应。除了药物说明书中记录的不良反应外，医疗保健提供者还应注意潜在的不良反应，如胸腔积液、腹水和肿瘤发展。
