一些天然多酚类生物修复剂抗肿瘤药效学作用的临床前定性评价。

P Rotinberg, S Kelemen, M Gramescu, H Rotinberg, V Nuta
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摘要

我们研究了POLYAS I和POLYAS II多酚生物修复剂对肿瘤生成过程的影响。POLYAS I和POLYAS II多酚生物修复剂是从叙利亚芦仙叶中分离纯化的,并在体外被鉴定为细胞毒性和/或细胞抑制剂。我们进行了一系列体内试验,研究了它们对Guerin T-8淋巴细胞嗜性上皮瘤和Walker 256癌肉瘤的影响。在临床前试验的第一阶段,我们使用了几种旨在评估其抗肿瘤活性指数的测试。然后在上述实体肿瘤系统的类似实验条件下使用相同的测试。我们的试验得出的抗肿瘤活性评价指标与美国和德国临床前筛选项目设定的参考指标进行了比较分析,指出了它们的相容性。因此,我们发现了相似的平均肿瘤回归值,分别是治疗组和对照组的平均肿瘤重量之比,以及连续重新测试产生的T/C产物。此外,由复测得出的T/C值在可接受的变异性范围内。这些结果突出了多酚类生物修复剂的抗肿瘤药物治疗作用,也证明了这种作用是可复制的。对这些制剂的药效学作用进行定性评价是进一步在临床前阶段对其抗肿瘤治疗效果进行定量药理学评价的条件。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Preclinical qualitative evaluation of the antitumoral pharmacodynamic action of some natural polyphenolic biopreparations.

We have investigated the impact of POLYAS I and POLYAS II polyphenolic biopreparations - specifically separated and purified from Asclepias syriaca leaves, and characterized in vitro as cytotoxic and/or cytostatic agents - on the tumor generation process. A series of in vivo tests of their effect on the development of Guerin T-8 lymphotropic epithelioma and Walker 256 carcinosarcoma were conducted. In a first stage of preclinical trial we had used several tests meant to evaluate their antitumoural activity indices. The same tests were then used under similar experimental conditions in the solid tumoral systems mentioned. A comparative analysis of the antitumoral activity evaluation indices resulting from our tests with the reference indices set by the American and German preclinical screening programs pointed to their compatibility. Thus, we found similar values of mean tumoral regressions, of the ratio between mean tumoral weights of the treated and control groups, respectively, of the T/C products resulting from successive re-tests. Also T/C values resulting from retests were within the limits of admissible variability range. All those results highlighted the antineoplastic pharmacotherapeutic effect of the polyphenolic biopreparations and also proved that effect to be replicable. The qualitative evaluation of the pharmacodynamic action of those preparations was a condition for their further quantitative pharmacological evaluation in point of antitumoral therapeutic effectiveness in a preclinical stage.

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