基于FAERS的益生菌制剂相关不良事件信号挖掘与分析  

Mining and Analysis of Adverse Event Signals Related to Probiotic Preparations Based on FAERS

作　　者：戴梦飞 丁海樱[1] 潘利斌 王婷婷 米秀芳 辛文秀 方罗[1] DAI Mengfei;DING Haiying;PAN Libin;WANG Tingting;MI Xiufang;XIN Wenxiu;FANG Luo(Department of Pharmacy,Zhejiang Cancer Hospital,Hangzhou Institute of Medicine(HIM),Chinese Academy of Sciences,Hangzhou 310022,China)

机构地区：[1]浙江省肿瘤医院药剂科,中国科学院杭州医学研究所,杭州310022

出　　处：《中国现代应用药学》2024年第21期2966-2970,共5页Chinese Journal of Modern Applied Pharmacy

基　　金：国家自然科学基金青年项目(82304608);浙江省自然科学基金项目(LQ23H310002);中国博士后科学基金项目(2023M743563);浙江省医药卫生科技计划项目(2023KY606,2023KY608)。

摘　　要：目的基于美国FDA不良事件报告系统(FDA adverse event reporting system,FAERS)数据库挖掘益生菌制剂相关的不良事件风险信号。方法收集FAERS数据库2004年第1季度—2023年第4季度期间报告的益生菌制剂相关不良事件数据,选择益生菌为首选可疑药物的记录进行分析。利用比例失衡法中的报告比值比法和综合标准法进行数据挖掘。结果共获取益生菌作为首选可疑药物的报告63份,报告了257条不良事件。使用比例失衡法共挖掘出益生菌相关不良事件信号13个,涉及6个系统器官分类,主要集中于胃肠系统功能紊乱。少部分不良事件未在中国批准的益生菌类药品说明书中记载,需更多直接证据证明益生菌与这些不良事件的因果关系。结论FAERS中益生菌制剂相关不良事件报告少,但仍存在一定的不良事件风险。这项研究为益生菌制剂的使用和不良反应的管理提供了重要参考。OBJECTIVE To mine the risk signals of adverse events associated with probiotics based on the Food and Drug Administration adverse event reporting system(FAERS)database.METHODS Data on adverse events related to probiotics reported in the FAERS database from the first quarter of 2004 to the fourth quarter of 2023 were collected.Records with probiotics as the primary suspect were selected for analysis.Data mining was conducted using the reporting odds ratio method and the medicines and health care products regulatory agency method within the disproportionality analysis.RESULTS A total of 63 reports with probiotics as the primary suspect were obtained,reporting 257 adverse events.Thirteen signals of adverse events related to probiotics were identified according to the disproportionality analysis,involving six system organ classes,primarily centered on gastrointestinal disorders.Some adverse events were not documented in the package inserts of probiotics approved in China,necessitating more evidence to establish causality between probiotics and these adverse events.CONCLUSION Although the number of reports of adverse events related to probiotics in FAERS is relatively low,some signals of adverse events are identified.This study provides important reference information for the management of adverse events of probiotics.

关 键 词：益生菌 FDA不良事件报告系统 药物警戒 比例失衡法 不良事件信号挖掘 

分 类 号：R969.3[医药卫生—药理学]