Worldwide Scientific Affairs, Herbalife Nutrition, Torrance, CA 90502, USA.
Product Science, Herbalife Nutrition, Torrance, CA 90502, USA.
Regul Toxicol Pharmacol. 2018 Jun;95:412-433. doi: 10.1016/j.yrtph.2018.03.019. Epub 2018 Mar 24.
A systematic review of published toxicology and human intervention studies was performed to characterize potential hazards associated with consumption of green tea and its preparations. A review of toxicological evidence from laboratory studies revealed the liver as the target organ and hepatotoxicity as the critical effect, which was strongly associated with certain dosing conditions (e.g. bolus dose via gavage, fasting), and positively correlated with total catechin and epigallocatechingallate (EGCG) content. A review of adverse event (AE) data from 159 human intervention studies yielded findings consistent with toxicological evidence in that a limited range of concentrated, catechin-rich green tea preparations resulted in hepatic AEs in a dose-dependent manner when ingested in large bolus doses, but not when consumed as brewed tea or extracts in beverages or as part of food. Toxico- and pharmacokinetic evidence further suggests internal dose of catechins is a key determinant in the occurrence and severity of hepatotoxicity. A safe intake level of 338 mg EGCG/day for adults was derived from toxicological and human safety data for tea preparations ingested as a solid bolus dose. An Observed Safe Level (OSL) of 704 mg EGCG/day might be considered for tea preparations in beverage form based on human AE data.
系统综述了已发表的毒理学和人体干预研究,以描述与饮用绿茶及其制剂相关的潜在危害。对实验室研究的毒理学证据的回顾表明,肝脏是靶器官,肝毒性是关键效应,这与某些给药条件(例如灌胃给予大剂量、禁食)强烈相关,并且与总儿茶素和表没食子儿茶素没食子酸酯(EGCG)含量呈正相关。对来自 159 项人体干预研究的不良事件(AE)数据的回顾得出的结果与毒理学证据一致,即当以大剂量给予浓缩、富含儿茶素的绿茶制剂时,仅在有限范围内的制剂会以剂量依赖的方式导致肝 AE,但当作为冲泡茶或以饮料形式或以食物的一部分摄入时则不会。毒理学和药代动力学证据进一步表明,儿茶素的内剂量是肝毒性发生和严重程度的关键决定因素。从作为固体大剂量给予的茶制剂的毒理学和人体安全性数据中得出了成年人每天 338mg EGCG 的安全摄入量水平。根据人体 AE 数据,对于饮料形式的茶制剂,可考虑将每天 704mg EGCG 的观察到的安全水平(OSL)。