回复：[仑卡奈单抗的上市后安全性问题：使用美国食品药品监督管理局不良事件报告系统的不成比例性分析]
Reply: [Post-marketing safety concerns with Lecanemab: a disproportionality analysis using the FDA adverse event reporting system].
作者信息
Xing Xiaoxuan, Wang Ke, Dong Xianzhe
机构信息
Department of Pharmacy, Xuanwu Hospital of Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing, P R China.
National Clinical Research Center for Geriatric Disorders, Beijing, China.
出版信息
Alzheimers Res Ther. 2025 Apr 8;17(1):77. doi: 10.1186/s13195-025-01728-4.
In this article, we have carefully read the author's comments on our published article regarding the post-marketing safety concerns of lecanemab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Pharmacovigilance studies based on the disproportionality analysis through the case/non-case design are common, and the details of this method deserve attention. We acknowledged the author's perspectives on the term "signal of disproportionate reporting (SDR)", and make some explanations on the SDR results for pancreatic carcinoma and the deduplication methods.
在本文中，我们仔细阅读了作者对我们已发表文章的评论，该评论基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库，涉及lecanemab的上市后安全性问题。基于病例/非病例设计的不成比例分析进行的药物警戒研究很常见，这种方法的细节值得关注。我们认可作者对“不成比例报告信号（SDR）”一词的观点，并对胰腺癌的SDR结果和去重方法做出一些解释。
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