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

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

Key words:  probiotics  FDA Adverse Event Reporting System (FAERS)  pharmacovigilance  disproportionality analysis  adverse event signal mining

摘要:

目的：基于美国FDA不良事件报告系统(FAERS)数据库挖掘益生菌制剂相关的不良事件风险信号,为益生菌制剂的安全使用提供参考。方法：收集FAERS数据库2004年第一季度至2023年第四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(PS)的记录进行分析。利用比例失衡法中的报告比值比(ROR)法和综合标准法(MHRA)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(SOC),主要集中于胃肠系统功能紊乱。少部分不良事件未在我国批准的益生菌类药品说明书中记载,需更多的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信息。

Abstract:

ABSTRACT: OBJECTIVE To mine the signals of adverse events related to probiotics based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database, providing a reference for the safety of probiotics. 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 (PS) were selected for analysis. Data mining was conducted using the Reporting Odds Ratio (ROR) method and the Medicines and Healthcare Products Regulatory Agency (MHRA) method within the disproportionality analysis. RESULTS A total of 63 reports with probiotics as the PS 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 (SOCs), 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 were identified. This study provides important reference information for the management of adverse events of probiotics.