Bae Ji-Won, Kim Da-Hyun, Lee Wha-Won, Kim Hyo-Young, Son Chang-Gue
Korean Medical College of Daejeon University, 22-5 Yongwoon-dong, Dong-gu, Daejeon 301-724, Republic of Korea.
Liver and Immunology Research Center, Daejeon Oriental Hospital of Daejeon University, 22-5 Daeheung-dong, Jung-gu, Daejeon 301-704, Republic of Korea.
J Ethnopharmacol. 2015 Mar 13;162:1-6. doi: 10.1016/j.jep.2014.12.023. Epub 2014 Dec 24.
Herbal medicines have been generally believed to be safe. With the increasing use of herbal medicine worldwide, however, the safety of traditional herbal drugs frequently becomes a medical issue.
This study was aimed to characterize the safe dose of herbal medicines through the systematic review for "human equivalent dose (HED)" from animal-based toxicity studies.
A literature search for animal-based toxicity studies of herbal medicines in eight databases, including PubMed and Embase, was performed without language restriction. From the "no observed adverse effect level (NOAEL)" of each animal study, HED values were then calculated according to the composition (single or multiple herbs) and indication of the medicines.
Among 729 relevant articles identified in the initial screening, 112 (233 studies comprising 105 single-herb and 128 multiple-herb studies) that met our inclusion criteria were finally reviewed. The total average HED value (from mouse, rat, rabbit and dog) was 278.1±358.0 mg/kg, and the values for single- and multiple-herb studies were 322.7±488.4 mg/kg and 241.5±189.2 mg/kg, respectively. When the studies were analyzed according to herbal drug indication, drugs used for revitalization had the highest HED value (433.0±265.2 mg/kg), while those for infectious diseases had the lowest (110.6±118.6 mg/kg).
Our results provide important information regarding the safe dose of herbal medicines; thus, these data offer researchers and practitioners information critical for drug development or clinical application.
人们普遍认为草药是安全的。然而，随着草药在全球范围内的使用日益增加，传统草药的安全性常常成为一个医学问题。
本研究旨在通过对基于动物毒性研究的“人类等效剂量（HED）”进行系统评价，来确定草药的安全剂量。
在包括PubMed和Embase在内的八个数据库中，对草药的基于动物的毒性研究进行了文献检索，无语言限制。然后根据每种动物研究的“未观察到不良反应水平（NOAEL）”，按照药物的成分（单味或多味草药）和适应证计算HED值。
在初步筛选出的729篇相关文章中，最终对符合纳入标准的112篇（233项研究，包括105项单味草药研究和128项多味草药研究）进行了综述。总的平均HED值（来自小鼠、大鼠、兔子和狗）为278.1±358.0mg/kg，单味草药研究和多味草药研究的值分别为322.7±488.4mg/kg和241.5±189.2mg/kg。当根据草药适应证对研究进行分析时，用于滋补的药物HED值最高（433.0±265.2mg/kg），而用于传染病的药物HED值最低（110.6±118.6mg/kg）。
我们的结果提供了有关草药安全剂量的重要信息；因此，这些数据为研究人员和从业者提供了对药物开发或临床应用至关重要的信息。
