University of Oulu, Department of Pharmacology and Toxicology, 90014 Oulu, Finland.
J Ethnopharmacol. 2012 Apr 10;140(3):587-93. doi: 10.1016/j.jep.2012.01.035. Epub 2012 Feb 1.
In traditional Chinese medicine (TCM), multicomponent and principally plant-derived drugs are used for disease prevention, symptom amelioration and treatment in a personalized manner. Because of their complex composition and consequent multiple targets and treatment objectives, the application of omics techniques and other integrative approaches seems inherently appropriate and even necessary for the demonstration of their potential preclinical and clinical safety and efficacy. This perspectives article provides proposals for the application of omics methods to the investigation of complex herbal products (CHP),(1) including Chinese herbal medicines (CHM), both in vitro and in vivo, for preclinical and clinical toxicity, pharmacokinetics, pharmacodynamics and efficacy tests. Ultimately, such approaches could aid regulatory scrutiny and potential acceptance, although currently there is no regulatory requirement of omics-based data in any submitted dossier to any regulatory agency, including for conventional drugs and CHP. However, it has been acknowledged that such studies are being increasingly performed, and almost surely will eventually be included into regulatory submission dossiers, possibly initially as supplementary materials. Specifically for CHM and CHP, omics can play a role both in determining product composition and its variability and in monitoring biological effects in carefully selected platforms. Predicting the future is difficult, but it seems possible that regulatory acceptance of omics techniques and a systems biology approach for the study of TCM, CHM and CHP will not be long delayed. It is expected that current studies and plans employing omics techniques and other integrative approaches will prove to be positive and informative.
在传统中医（TCM）中，多成分的、主要来源于植物的药物被用于个性化的疾病预防、症状改善和治疗。由于其复杂的成分，继而具有多个靶点和治疗目标，因此，对于其潜在的临床前和临床安全性和疗效的证明，似乎内在地适合甚至必须应用组学技术和其他综合方法。本文观点为将组学方法应用于复杂草药产品（CHP），包括中草药（CHM）的体外和体内的研究，提出了建议，用于临床前和临床毒性、药代动力学、药效学和疗效测试。最终，这些方法可以帮助监管审查和潜在的接受，尽管目前，对于任何监管机构提交的任何档案，包括常规药物和 CHP，都没有基于组学的数据的监管要求。然而，已经认识到，这种研究正在越来越多地进行，并且几乎可以肯定最终将被纳入监管提交档案，可能最初作为补充材料。对于 CHM 和 CHP 来说，组学可以在确定产品成分及其可变性和在精心选择的平台上监测生物效应方面发挥作用。预测未来是困难的，但似乎有可能，监管部门对组学技术和系统生物学方法的接受，以及对 TCM、CHM 和 CHP 的研究，不会被拖延太久。预计目前采用组学技术和其他综合方法的研究和计划将被证明是积极和有益的。
