Basch Ethan M, Servoss Julie C, Tedrow Usha B
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
J Herb Pharmacother. 2005;5(1):3-15.
Herbal therapies are used by more than 12% of the U.S. population each year, resulting in annual out-of-pocket expenses above $5 billion. Utilization rates are particularly high among patients with chronic diseases, and in patients frequently seen in clinic by physicians and nurse practitioners. Most physicians do not receive formal education regarding the safety of these therapies, and there is growing concern in the medical community about the potential risks to patients and the paucity of reliable information. Numerous adverse effects and interactions have been attributed to dietary supplements, based on variable levels of evidence ranging from historical use or anecdotes to pre-clinical research or high-quality clinical trials. Significant potential morbidity and costs have been indirectly associated with herb/supplement-drug interactions, including increased emergency room visits, outpatient clinic visits, and perioperative complications. However, most research has focused on efficacy rather than safety. Post-market surveillance is complicated by the uneven standardization of products between manufacturers, and in some cases between batches produced by the same manufacturer. To assure public safety around the use of dietary supplements within the framework of existing legislation and market realities, schema must evolve to more systematically monitor the safety of agents in the post-market environment; identify potentially dangerous supplements (and/or constituents); study the mechanism and potential hazards of these identified products; and clarify the process by which products may be considered for removal from the market. We discuss research and educational paradigms within this context which make use of existing surveillance mechanisms to more efficiently identify agents of particular concern. Specific examples are given.
每年超过12%的美国人口使用草药疗法，导致每年自付费用超过50亿美元。慢性病患者以及医生和执业护士在诊所中经常见到的患者的使用率尤其高。大多数医生没有接受过关于这些疗法安全性的正规教育，医学界对患者的潜在风险以及可靠信息的匮乏越来越担忧。基于从历史使用或轶事到临床前研究或高质量临床试验等不同程度的证据，许多不良反应和相互作用都归因于膳食补充剂。草药/补充剂与药物的相互作用间接导致了重大的潜在发病率和成本，包括急诊室就诊、门诊就诊和围手术期并发症的增加。然而，大多数研究都集中在疗效而非安全性上。由于制造商之间产品标准化程度参差不齐，在某些情况下同一制造商生产的不同批次产品之间也存在差异，使得上市后监测变得复杂。为了在现有立法和市场现实的框架内确保膳食补充剂使用的公共安全，必须改进模式，以便更系统地监测上市后环境中药物的安全性；识别潜在危险的补充剂（和/或成分）；研究这些已识别产品的作用机制和潜在危害；并阐明可考虑将产品从市场上移除的程序。我们在此背景下讨论研究和教育范式，这些范式利用现有的监测机制来更有效地识别特别值得关注的药物。并给出了具体例子。
