中草药三叶青抗肿瘤作用机制实验研究和临床应用

目的拟对民间常用中草药三叶青抗恶性肿瘤作用机制做深入的实验研究,并在此基础上按《保健食品注册管理办法(试行)》要求以三叶青为主,配以药食同用的黄芪、人参皂苷制成制剂金芪片经过临床验证研制成抗恶性肿瘤的功能性保健食品。方法按《保健食品检验与评价技术规范》对三叶青进行抗肿瘤功能实验、提高人体免疫功能实验和食品安全性毒理学评价实验,证实三叶青有明显抗肿瘤作用,且长期服用安全无毒。以三叶青为主配以黄芪、人参皂苷制成的制剂金芪片经临床验证,证实疗效确切无毒副反应。结果各项实验结果证实三叶青及金芪片提取物对人体肝癌细胞HepG2活性具有较强抑制作用,对小鼠HepG2细胞的端粒酶基因表达有抑制作用,并又增强小鼠细胞免疫和体液免疫功能的作用。三叶青提取物经急性毒性试验及长期毒性实验证实安全无毒。金芪片临床验证:120例恶性肿瘤病人服用90天,完全缓解52例,部分缓解42例,稳定18例,进展8例,总有效率78.33%。结论表明三叶青及其制剂金芪片对恶性肿瘤病人有较好的效果,值得推广,并可期盼做进一步研究开发成抗恶性肿瘤新药。

Study on the Anti - tumor Mechanism and the Clinical Application of Tetrastigma Hemsleyanum Diels et. Gilg

Objective To reveal the anti-tumor mechanism of Tetrastigma Hemsleyanum Diels et.Gilg penetratingly and make it into a new praeparatum-Jinqi Pian,and furtherly evaluate the anti-tumor effects of Jinqi Pian in the clinical application.Methods We study the anti-tumor effects and mechanism of Tetrastigma Hemsleyanum Diels et.Gilg,and evaluate the toxicity of Tetrastigma Hemsleyanum Diels et.Gilg according to the SFDA' regulation on supplement food.In the clinical application,we evaluate the anti-tumor effects and its toxicity of Jinqi Pian.Results The extract of Tetrastigma Hemsleyanum Diels et.Gilg have a significant toxicological effect on hepatocellular carcinoma cell line HepG2,as it was conformed to inhibit the gene expression of telomerase of HepG2,and enhance immune function of mice including cellar immunity and humoral immunity,and these could be some of the anti-tumor mechanisms of Tetrastigma Hemsleyanum Diels et.Gilg.The toxicity experiment indicated that the toxicity of Tetrastigma Hemsleyanum Diels et is very low.In the clinical application,52 patients are recovered,42 patients are relieved,18 patient are lasting,and 8 patients are minor relieved in the 120 patients with tumor,and the total effective rate is 78.3%,and we found no obviously toxicity of Jinqi Pian.by oral use in our study.Conclusions Tetrastigma Hemsleyanum Diels et.Gilg and its praeparatum Jinqi Pian possessed a significant anti-tumor effects without no obviously toxicity,and further study needed before they were made into one kind of new drug.