Wang Yitong, Tan Weifu, Li Xuyang, Yang Guangli, Wang Yunxiao, Liao Jing, Lu Aner, Zhang Guoqing, Chen Kuidai, Yang Liling, Li Wei
Department of Neonatology, Binhaiwan Central Hospital of Dongguan, Dongguan, China.
Department of Pediatric, The First Clinical Medical College of Jinan University, The First Affiliated Hospital of Jinan University, Guangzhou, China.
Front Cell Infect Microbiol. 2025 May 13;15:1455735. doi: 10.3389/fcimb.2025.1455735. eCollection 2025.
Probiotics are recognized as beneficial foods, but adverse reactions reported by individuals still exist. This study aims to analysis adverse events (AE) related to probiotics from the FAERS database from the first quarter (Q1) of 2005 to the fourth quarter (Q4) of 2023.
The AE data related to probiotic from the 2005 Q1 to the 2023 Q4 were collected. R language was applied to analyze the standardized AE data and three algorithms including the reporting odds ratio (ROR), the proportional reporting ratio (PRR) and the empirical Bayes geometric mean (EBGM) were used to identify AE signals.
In this study, 10,698,312 reports were collected from the FAERS database, of which 74 probiotic-related adverse events were reported. About one third of the reported cases were older than 60 years.36.36% of the reported cases required Hospitalization. A total of 285 preference terms (PTS) and 15 system organ classes (SOC) were identified. In the overall analysis, only 9 PTs and 2 SOCs met significant disproportionality for all three algorithms simultaneously. SOCs included Gastrointestinal disorders (N=97, ROR=5.3, PRR=3.84, EBGM=3.84) and Hepatobiliary disorders (N=9, ROR =3.39, PRR=3.32, EBGM=3.32). PTs included Gastrointestinal pain (ROR=77.76, PRR=76.69, EBGM=76.63), Hypophagia (ROR=24.13, PRR=23.88, EBGM=28.88), and Hepatobiliary disorders (N=97, ROR=5.3, PRR=3.84, EBGM=3.84) and Flatulence (ROR=23.75, PRR=23.28, EBGM=23.27) were the top four highest. Meanwhile, s found new unique adverse signals such as Agitation (ROR=12.48, PRR=12.32, EBGM=12.32) and Anxiety (ROR=4.10, PRR=4.04, EBGM=4.04). Additionally, subgroup analyses were performed to identify AE signals based on gender and age. Metabolism and nutrition disorders (N=6, ROR=3.21, PRR=3.04, EBGM=3.04) and Asthenia (N=3, ROR=5.9, PRR=5.71, EBGM=5.71) were unique AE signal for the male group.
Although, the risk of adverse reactions arising from the application of probiotics cannot be ignored. However, However, the results of this FAERS-based study continue to support the overall safety of probiotic preparations. It is necessary to pay attention to the potential influence of factors such as gender and age on the effects and adverse reactions of probiotic application in basic research and clinical application.
益生菌被认为是有益食品，但仍有个体报告的不良反应存在。本研究旨在分析2005年第一季度（Q1）至2023年第四季度（Q4）来自美国食品药品监督管理局不良事件报告系统（FAERS）数据库中与益生菌相关的不良事件（AE）。
收集2005年第一季度至2023年第四季度与益生菌相关的AE数据。应用R语言分析标准化的AE数据，并使用三种算法，包括报告比值比（ROR）、比例报告比值比（PRR）和经验贝叶斯几何均值（EBGM）来识别AE信号。
在本研究中，从FAERS数据库收集了10,698,312份报告，其中报告了74例与益生菌相关的不良事件。约三分之一的报告病例年龄超过60岁。36.36%的报告病例需要住院治疗。共识别出285个首选术语（PTS）和15个系统器官类别（SOC）。在总体分析中，只有9个PTS和2个SOC同时满足所有三种算法的显著不成比例性。SOC包括胃肠疾病（N = 97，ROR = 5.3，PRR = 3.84，EBGM = 3.84）和肝胆疾病（N = 9，ROR = 3.39，PRR = 3.32，EBGM = 3.32）。PTS包括胃肠疼痛（ROR = 77.76，PRR = 76.69，EBGM = 76.63）、食欲减退（ROR = 24.13，PRR = 23.88，EBGM = 28.88）、肝胆疾病（N = 97，ROR = 5.3，PRR = 3.84，EBGM = 3.84）和肠胃胀气（ROR = 23.75，PRR = 23.28，EBGM = 23.27）是前四大最高的。同时，发现了新的独特不良信号，如激动（ROR = 12.48，PRR = 12.32，EBGM = 12.32）和焦虑（ROR = 4.10，PRR = 4.04，EBGM = 4.04）。此外，进行亚组分析以根据性别和年龄识别AE信号。代谢和营养障碍（N = 6，ROR = 3.21，PRR = 3.04，EBGM = 3.04）和虚弱（N = 3，ROR = 5.9，PRR = 5.71，EBGM = 5.71）是男性组独特的AE信号。
虽然，应用益生菌引起不良反应的风险不容忽视。然而，然而，这项基于FAERS的研究结果继续支持益生菌制剂的总体安全性。在基础研究和临床应用中，有必要关注性别和年龄等因素对益生菌应用效果和不良反应的潜在影响。
