Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.
Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Br J Clin Pharmacol. 2021 Mar;87(3):741-753. doi: 10.1111/bcp.14460. Epub 2020 Jul 20.
Several cases of acute non-infectious cholestatic hepatitis recently appeared in Italy following consumption of Curcuma longa-containing dietary supplements. The aim of this research was to describe the Tuscan (Italy) cases of acute hepatitis and to compare them with similar cases of hepatotoxicity published in the literature by performing a systematic review.
Records of Tuscan cases of acute hepatitis were obtained from the Italian Phytovigilance system. Each spontaneous report was analysed in order to collect all relevant clinical information of patients and information concerning the Curcuma longa-containing dietary supplement. Moreover, both the RUCAM and WHO-UMC systems were used to evaluate the causal relationship between the use of dietary supplement and acute hepatitis. A systematic literature review was performed in MEDLINE and Embase and all case-reports and case-series published in English were included.
Seven cases of acute hepatitis occurring in Tuscany up to September 2019 are described. In all cases, hepatotoxicity was associated with Curcuma longa formulations with high bioavailability and high dosage of curcumin/curcuminoids. The causal relationship was also supported by the positive dechallenge observed in most cases. In the 23 cases identified through the systematic review, the majority of patients were concomitantly exposed to at least one other medication and 16 of them experienced a positive dechallenge.
Within the frame of poorly controlled and regulated products, such as dietary supplements, the evaluation of Italian cases of Curcuma longa-induced acute hepatitis and the systematic review of literature confirmed the association between Curcuma longa and liver injury.
近期在意大利，有几例食用含姜黄的膳食补充剂后出现的急性非传染性胆汁淤积性肝炎病例。本研究旨在描述托斯卡纳（意大利）的急性肝炎病例，并通过系统回顾比较与文献中报道的类似肝毒性病例。
从意大利植物药警戒系统中获取托斯卡纳地区急性肝炎病例记录。对每个自发报告进行分析，以收集患者的所有相关临床信息和含姜黄的膳食补充剂信息。此外，还使用 RUCAM 和 WHO-UMC 系统评估膳食补充剂使用与急性肝炎之间的因果关系。在 MEDLINE 和 Embase 上进行系统文献回顾，纳入所有以英文发表的病例报告和病例系列。
描述了截至 2019 年 9 月在托斯卡纳发生的 7 例急性肝炎病例。在所有情况下，肝毒性与具有高生物利用度和高剂量姜黄素/姜黄素类的姜黄制剂相关。大多数情况下观察到停药后病情改善，这也支持了因果关系。在通过系统回顾确定的 23 例病例中，大多数患者同时暴露于至少一种其他药物，其中 16 例经历了停药后病情改善。
在像膳食补充剂这样的管制和监管不完善的产品中，评估意大利的姜黄引起的急性肝炎病例和系统回顾文献证实了姜黄与肝损伤之间的关联。
