Rotinberg P, Kelemen S, Gramescu M, Rotinberg H, Nuta V
Institute of Biological Research, Jassy, Romania.
Rom J Physiol. 2000 Jan-Dec;37(1-4):91-103.
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.
我们研究了聚多酚生物制剂POLYAS I和POLYAS II(从叙利亚马利筋叶片中专门分离和纯化得到,在体外被表征为细胞毒性和/或细胞生长抑制剂)对肿瘤发生过程的影响。对它们作用于格林T - 8嗜淋巴细胞上皮瘤和沃克256癌肉瘤发展的一系列体内试验进行了研究。在临床前试验的第一阶段,我们使用了多项试验来评估它们的抗肿瘤活性指标。然后在上述实体肿瘤系统的类似实验条件下使用相同的试验。将我们试验得出的抗肿瘤活性评估指标与美国和德国临床前筛查项目设定的参考指标进行比较分析,结果表明它们具有兼容性。因此,我们发现平均肿瘤消退值、治疗组与对照组平均肿瘤重量之比以及连续重新测试得出的T/C乘积具有相似的值。重新测试得出的T/C值也在可接受的变异性范围内。所有这些结果突出了多酚生物制剂的抗肿瘤药物治疗效果,也证明了该效果是可重复的。对这些制剂药效学作用的定性评估是在临床前阶段对其抗肿瘤治疗效果进行进一步定量药理学评估的条件。