与草药膳食补充剂和含泻药的非处方药相关的不良事件：意大利植物药警戒和药物警戒系统的 10 年更新。
Adverse events related to herbal dietary supplements and over-the-counter medications containing laxatives: a 10-year update from the Italian Phytovigilance and Pharmacovigilance systems.
机构信息
Dipartimento di Neuroscienze, Psicologia, Area del Farmaco e Salute del Bambino, Sezione di Farmacologia e Tossicologia, Università degli Studi di Firenze, Florence, Italy - Centro Regionale Toscano di Farmacovigilanza, Florence, Italy.
Dipartimento di Neuroscienze, Psicologia, Area del Farmaco e Salute del Bambino, Sezione di Farmacologia e Tossicologia, Università degli Studi di Firenze, Florence, Italy - Centro di Ricerca e Innovazione in Fitoterapia e Medicina Integrata, Centro di Riferimento per la Fitoterapia, Regione Toscana, Azienda Ospedaliera Universitaria Careggi, Florence, Italy.
出版信息
Ann Ist Super Sanita. 2022 Apr-Jun;58(2):131-138. doi: 10.4415/ANN_22_02_09.
INTRODUCTION
Products containing anthraquinones (AQ) are associated with an increased risk of serious adverse events (AEs). We performed an update of the available evidence retrieved by the spontaneous reports of AE associated with herbal dietary supplement (DS) and over-the-counter medications (OTC-M) used as laxatives.
METHODS
Analysis and evaluation of AE reports retrieved from the Italian Phytovigilance and Pharmacovigilance systems was performed from February 2011 to December 2020.
RESULTS
Totally 110 AE reports, 24 related to herbal DS and 86 to OTC-M, were analyzed. Most subjects were females. Herbal products analyzed mostly contained AQ derivatives. Most AEs were gastrointestinal (41.6%), central nervous system (18.2%), and dermatological disorders (12.6%).
CONCLUSIONS
The number of AE reports recorded in the last 10 years is still relatively low. However, given the seriousness of some AEs, that does not represent a guarantee of safety. This study may contribute to enhance public awareness on the risks associated with misuse or abuse of laxatives.
简介
含蒽醌类（AQ）的产品与严重不良事件（AE）的风险增加有关。我们对与作为泻药使用的草药膳食补充剂（DS）和非处方药物（OTC-M）相关的 AE 自发报告中检索到的现有证据进行了更新。
方法
从 2011 年 2 月至 2020 年 12 月，对从意大利植物药和药物警戒系统中检索到的 AE 报告进行了分析和评估。
结果
共分析了 110 份 AE 报告，其中 24 份与草药 DS 相关，86 份与 OTC-M 相关。大多数受试者为女性。分析的草药产品大多含有 AQ 衍生物。大多数 AE 为胃肠道（41.6%）、中枢神经系统（18.2%）和皮肤病（12.6%）。
结论
在过去 10 年中记录的 AE 报告数量仍然相对较低。然而，鉴于一些 AE 的严重性，这并不能保证安全性。本研究可能有助于提高公众对滥用或滥用泻药相关风险的认识。
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