Dobos G J, Tan L, Cohen M H, McIntyre M, Bauer R, Li X, Bensoussan A
Alfried Krupp von Bohlen and Halbach-Foundation, University Duisburg-Essen at the Kliniken Essen-Mitte, Am Deimelsberg 34 A, 45276 Essen, Germany.
Complement Ther Med. 2005 Sep;13(3):183-90. doi: 10.1016/j.ctim.2005.06.004.
Traditional Chinese herbal Medicine (TCHM) has been gaining interest and acceptance world wide. TCHM provides on the one side promising perspective of scientific interest and on the other side possible health risks if TCHM drugs are not controlled with respect to quality standards or if practitioners for TCHM are not well trained. This paper outlines an introduction to the scientific aspects and potential risks of TCHM therapy followed by a brief, exploratory overview of the current status of TCHM regulations in certain Western countries like the USA, United Kingdom, Germany, Australia and in China as the Eastern origin country of TCHM. Legal foundations to establish quality and safety standards for TCHM crude drugs and ready-made formulas exist in some countries on a local basis but in practice are poorly enforced, where this products have no drug status. In addition practitioners treating patients with TCHM should be well versed in the pharmacology, side effects, and interactions of these substances with Western medicines and should be certified on a regular basis.
传统中药（TCHM）在全球范围内越来越受到关注和认可。一方面，传统中药展现出了具有科学研究价值的前景；另一方面，如果不对传统中药的质量标准进行管控，或者传统中药从业者未接受良好培训，那么传统中药可能会带来健康风险。本文概述了传统中医疗法的科学层面和潜在风险，随后简要、探索性地综述了美国、英国、德国、澳大利亚等某些西方国家以及作为传统中药发源地的中国的传统中药监管现状。一些国家在地方层面存在建立传统中药原料药和成品配方质量与安全标准的法律基础，但在实际操作中执行不力，因为这类产品没有药品地位。此外，使用传统中药治疗患者的从业者应精通这些药物的药理学、副作用以及它们与西药的相互作用，并且应定期获得认证。
