{"title":"回复：[利卡耐单抗上市后的安全问题：使用FDA不良事件报告系统的歧化分析]。","authors":"Xiaoxuan Xing, Ke Wang, Xianzhe Dong","doi":"10.1186/s13195-025-01728-4","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":7516,"journal":{"name":"Alzheimer's Research & Therapy","volume":"17 1","pages":"77"},"PeriodicalIF":7.6000,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11980224/pdf/","citationCount":"0","resultStr":"{\"title\":\"Reply: [Post-marketing safety concerns with Lecanemab: a disproportionality analysis using the FDA adverse event reporting system].\",\"authors\":\"Xiaoxuan Xing, Ke Wang, Xianzhe Dong\",\"doi\":\"10.1186/s13195-025-01728-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":7516,\"journal\":{\"name\":\"Alzheimer's Research & Therapy\",\"volume\":\"17 1\",\"pages\":\"77\"},\"PeriodicalIF\":7.6000,\"publicationDate\":\"2025-04-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11980224/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Alzheimer's Research & Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13195-025-01728-4\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Alzheimer's Research & Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13195-025-01728-4","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Reply: [Post-marketing safety concerns with Lecanemab: a disproportionality analysis using the FDA adverse event reporting system].
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.
期刊介绍：
Alzheimer's Research & Therapy is an international peer-reviewed journal that focuses on translational research into Alzheimer's disease and other neurodegenerative diseases. It publishes open-access basic research, clinical trials, drug discovery and development studies, and epidemiologic studies. The journal also includes reviews, viewpoints, commentaries, debates, and reports. All articles published in Alzheimer's Research & Therapy are included in several reputable databases such as CAS, Current contents, DOAJ, Embase, Journal Citation Reports/Science Edition, MEDLINE, PubMed, PubMed Central, Science Citation Index Expanded (Web of Science) and Scopus.
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