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用于治疗癌症的植物药:理论依据、当前数据概述以及I期和II期试验的方法学考量

Botanical medicines for the treatment of cancer: rationale, overview of current data, and methodological considerations for phase I and II trials.

作者信息

Vickers Andrew

机构信息

Integrative Medicine Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA.

出版信息

Cancer Invest. 2002;20(7-8):1069-79. doi: 10.1081/cnv-120005926.

DOI:10.1081/cnv-120005926
PMID:12449740
Abstract

There appears to be exceptional and growing public enthusiasm for botanical, or "herbal", medicines, especially amongst cancer patients. This has recently begun to be matched by increasing scientific attention. Whilst it is known that plant extracts are active against cancer, the standard approach has been to isolate, synthesize and administer the single chemical compound thought responsible for this effect. However, different components in a botanical may have synergistic activities. There is also some evidence that the presence of multiple compounds in a botanical extract can buffer the toxic effects of a single constituent. Though many of the botanicals popular among patients are probably not of benefit (e.g. Mistletoe, Pau D'arco), several botanicals have shown promise in Phase III (Sho-saiko-to, PSK) or Phase II (PC-SPES) trial. Quality control of botanicals poses significant challenges: small differences in genetics, soil, temperature, moisture and time of harvesting can lead to significant differences in the concentration of important constituents. Phase I and II methodology is also problematic: botanicals have low toxicity and are unlikely to cause rapid tumor regression. There is currently minimal regulation of botanical medicines.

摘要

对于植物药或“草药”,公众表现出了格外且不断增长的热情,尤其是在癌症患者当中。最近,这种热情开始得到越来越多的科学关注。虽然已知植物提取物对癌症有活性,但标准方法一直是分离、合成并施用被认为对此效果负责的单一化合物。然而,一种植物中的不同成分可能具有协同活性。也有一些证据表明,植物提取物中多种化合物的存在可以缓冲单一成分的毒性作用。虽然患者中流行的许多植物药可能并无益处(如槲寄生、南非茶),但几种植物药在III期试验(小柴胡汤、PSK)或II期试验(PC-SPES)中显示出了前景。植物药的质量控制面临重大挑战:遗传、土壤、温度、湿度和收获时间的微小差异都可能导致重要成分浓度的显著差异。I期和II期试验方法也存在问题:植物药毒性低,不太可能导致肿瘤迅速消退。目前对植物药的监管极少。

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