Unità di Farmacoepidemiologia e Farmacosorveglianza, Centro Nazionale Ricerca e Valutazione Preclinica e Clinica dei Farmaci, Istituto Superiore di Sanità, Rome, Italy.
Dipartimento di Sicurezza Alimentare, Nutrizione e Sanità Pubblica Veterinaria, Istituto Superiore di Sanità, Rome, Italy.
Ann Ist Super Sanita. 2024 Jul-Sep;60(3):225-233. doi: 10.4415/ANN_24_03_08.
Beehive products are widely used in food supplements; however, their composition variability and allergenic components have raised some concerns. This work aims to provide information about the beehive products safety profile by evaluating the suspected adverse reactions (ARs).
The suspected report of ARs collected within the Italian Phytovigilance System (IPS) were evaluated. The clinical and demographic characteristics of the cases were described, and the causality assessment performed.
61 reports were analysed, mainly concerned women. Serious events were reported in 17 forms (28%). The ARs (n=116) referred to respiratory (25.0%), skin (24.1%), and gastrointestinal disorders (21.5%). Label warnings for atopic subjects were present only in 7 food supplements. The causality assessment was mostly probable (54.1%).
Present findings outline relevant information about the safety issues of beehive product consumption, especially in atopic or allergic subjects, and strengthen the importance of IPS to point out safety signals.
蜂巢产品广泛应用于食品补充剂；然而，其组成的可变性和变应原成分引起了一些关注。本工作旨在通过评估疑似不良反应（ARs）来提供有关蜂巢产品安全性概况的信息。
评估了在意大利植物药警戒系统（IPS）中收集的疑似 ARs 报告。描述了病例的临床和人口统计学特征，并进行了因果关系评估。
分析了 61 份报告，主要涉及女性。17 种（28%）报告了严重事件。ARs（n=116）涉及呼吸系统（25.0%）、皮肤（24.1%）和胃肠道疾病（21.5%）。仅有 7 种食品补充剂对过敏体质者的标签警告。因果关系评估大多是可能的（54.1%）。
目前的研究结果概述了有关蜂巢产品消费安全性问题的重要信息，特别是在过敏或过敏体质者中，并且强调了 IPS 指出安全信号的重要性。
