Roe Amy L, Paine Mary F, Gurley Bill J, Brouwer Kenneth R, Jordan Scott, Griffiths James C
Product Safety & Regulatory Affairs, The Procter & Gamble Company, Cincinnati, OH 45040, United States.
Experimental and Systems Pharmacology, College of Pharmacy, Washington State University, Spokane, WA 99210, United States.
Regul Toxicol Pharmacol. 2016 Apr;76:1-6. doi: 10.1016/j.yrtph.2016.01.004. Epub 2016 Jan 9.
The use of natural products (NPs), including herbal medicines and other dietary supplements, by North Americans continues to increase across all age groups. This population has access to conventional medications, with significant polypharmacy observed in older adults. Thus, the safety of the interactions between multi-ingredient NPs and drugs is a topic of paramount importance. Considerations such as history of safe use, literature data from animal toxicity and human clinical studies, and NP constituent characterization would provide guidance on whether to assess NP-drug interactions experimentally. The literature is replete with reports of various NP extracts and constituents as potent inhibitors of drug metabolizing enzymes, and transporters. However, without standard methods for NP characterization or in vitro testing, extrapolating these reports to clinically-relevant NP-drug interactions is difficult. This lack of a clear definition of risk precludes clinicians and consumers from making informed decisions about the safety of taking NPs with conventional medications. A framework is needed that describes an integrated robust approach for assessing NP-drug interactions; and, translation of the data into formulation alterations, dose adjustment, labelling, and/or post-marketing surveillance strategies. A session was held at the 41st Annual Summer Meeting of the Toxicology Forum in Colorado Springs, CO, to highlight the challenges and critical components that should be included in a framework approach.
北美各年龄段人群对天然产物（NPs）的使用持续增加，其中包括草药和其他膳食补充剂。该人群可以获取传统药物，在老年人中观察到显著的多重用药情况。因此，多成分天然产物与药物之间相互作用的安全性是一个至关重要的话题。诸如安全使用历史、动物毒性和人体临床研究的文献数据以及天然产物成分特征等因素，将为是否通过实验评估天然产物与药物的相互作用提供指导。文献中充斥着各种天然产物提取物和成分作为药物代谢酶和转运体的强效抑制剂的报道。然而，由于缺乏天然产物表征或体外测试的标准方法，将这些报道外推至临床相关的天然产物与药物相互作用是困难的。这种风险定义不明确的情况使临床医生和消费者无法就同时服用天然产物和传统药物的安全性做出明智决策。需要一个框架来描述评估天然产物与药物相互作用的综合稳健方法；并将数据转化为制剂变更、剂量调整、标签和/或上市后监测策略。在科罗拉多州斯普林斯举行的毒理学论坛第41届年度夏季会议上举办了一次会议，以强调框架方法中应包含的挑战和关键要素。
