Fong Harry H S
UIC/NIH Center for Botanical Dietary Supplements Research, College of Pharmacy, University of Illinois at Chicago, 60612, USA.
Integr Cancer Ther. 2002 Sep;1(3):287-93; discussion 293. doi: 10.1177/153473540200100313.
The integration of herbal medicine into modern medical practices including cancer treatments must take into account the interrelated issues of quality, safety, and efficacy. Quality is the paramount issue because it can affect the efficacy and/or safety of the herbal products being used. Current product quality ranges from very high to very low due to intrinsic, extrinsic, and regulatory factors. Intrinsically, species differences, organ specificity, diurnal and seasonal variations can affect the qualitative and quantitative accumulation of active chemical constituents in the source medicinal plants. Extrinsically, environmental factors; field collection methods such as cultivation, harvest, post-harvest transport and storage; manufacturing practices; inadvertent contamination and substitution; and intentional adulteration are contributing factors to the quality of herbal medicinal products. Source plant materials that are contaminated with microbes, microbial toxins, environmental pollutants, or heavy metals; or finished products that are adulterated with foreign toxic plants or synthetic pharmaceutical agents can lead to adverse events. Substandard source materials or finished products will yield therapeutically less effective agents. Herbal medicine quality can also be attributed to regulatory practices. In a number of countries, herbal medicines are unregulated, which has led to product quality differences. Product quality improvement may be achieved by implementing control measures from the point of medicinal plant procurement under good agricultural practices (GAPs) and the manufacture of the finished botanical products under good manufacturing practices (GMPs), plus post-marketing quality assurance surveillance. The lack of pharmacological and clinical data on the majority of herbal medicinal products is a major impediment to the integration of herbal medicines into conventional medical practices. For valid integration, pharmacological and especially, clinical studies, must be conducted on those plants lacking such data. Adverse events, including drug-herb interaction must also be monitored to promote a safe integration of efficacious herbal medicine into conventional medical practices.
将草药融入包括癌症治疗在内的现代医疗实践中，必须考虑质量、安全性和有效性等相互关联的问题。质量是首要问题，因为它会影响所使用草药产品的有效性和/或安全性。由于内在、外在和监管因素，目前产品质量参差不齐，从非常高到非常低。从内在因素来看，物种差异、器官特异性、昼夜和季节变化会影响源药用植物中活性化学成分的定性和定量积累。从外在因素来看，环境因素；田间采集方法，如种植、收获、收获后运输和储存；生产规范；无意的污染和替代；以及故意掺假都是影响草药产品质量的因素。被微生物、微生物毒素、环境污染物或重金属污染的源植物材料；或掺有外来有毒植物或合成药剂的成品可能会导致不良事件。不合格的源材料或成品会产生治疗效果较差的药剂。草药质量也可归因于监管措施。在许多国家，草药不受监管，这导致了产品质量差异。可以通过在良好农业规范（GAPs）下从药用植物采购环节实施控制措施，以及在良好生产规范（GMPs）下生产成品植物药产品，并加上上市后质量保证监督来提高产品质量。大多数草药产品缺乏药理和临床数据是将草药融入传统医疗实践的主要障碍。为了实现有效整合，必须对那些缺乏此类数据的植物进行药理研究，尤其是临床研究。还必须监测不良事件，包括药物与草药的相互作用，以促进有效的草药安全融入传统医疗实践。
