扶正抗癌冲剂结合化疗治疗晚期胃癌的临床与实验研究

Clinical and experimental studies on Fuzheng anti cancer granula combined with chemotherapy in advanced gastric cancer *

目的研究中药扶正抗癌冲剂对晚期胃癌的疗效，观察体内外抗癌作用及其作用机制．方法采用扶正抗癌冲剂结合化疗治疗Ⅲ，Ⅳ期胃癌患者２４９例（姑息性手术１６１例，未手术８８例）．两类患者分别随机分为中药、化疗及中药加化疗组，进行疗效观察；并检测治疗前后患者外周血Ｔ细胞亚群、ＮＫ细胞活性、免疫调节因子水平变化，体外采用３种人胃癌细胞株（ＭＫＮ４５，ＭＫＮ２８，ＳＧＣ７９０１）进行抗癌试验，并用电镜观察癌细胞结构变化；并对人胃癌细胞ＳＧＣ７９０１裸鼠模型进行体内抗癌研究．结果扶正抗癌冲剂结合化疗组患者生活质量显著改善，未手术者一、二、三年生存率显著提高，分别为７３３％，５３３％，２３３％；中位生存期显著延长为１３４４ｍｏ．而单纯化疗组分别为４００％，２３３％，３３％，中位生存期６１２ｍｏ；两组比较疗效显著优于单纯化疗组（Ｐ＜００１）．该药治疗后，患者细胞免疫功能显著改善，免疫调节因子（ＩＬ２，ＩＬ２Ｒ，ＩＦＮα）水平提高，免疫抑制因子ｓＩＬ２Ｒ明显下降，ＮＫ细胞活性增强．扶正抗癌冲剂在体外对低分化胃癌细胞株ＭＫＮ４５具有较强的直接杀伤和生长抑制作用，对ＳＧＣ７９０１裸鼠模型治疗组平均瘤重较对照组显著减轻?

AIM To study the effects of Fuzheng anti cancer granula for advanced gastric cancer and its mechanism. METHODS Advanced gastric cancer patients ( n =249), including 161 treated surgically and 88 unsurgically, were divided randomly into chemotherapy group, Chinese herbal medicine group and combination group, and their clinical efficacy, changes of cellular immunity and regulatory factors and NK cell activity were observed. The inhibiting and killing effects of Fuzheng anti cancer granula in three gastric cancer cell lines were evaluated and animal experiments were carried out. RESULTS In the combination group, non operation the 1 ,2 and 3 year survival rates in those treated without operation were 73 3%, 53 3% and 23 3% respectively, with a mean survival period of 13 4 months; in chemotherapy group, 40 0%, 28 3% and 3 3% respectively, with a mean survival period of 6 1 months, being obviously different between the two groups ( P <0 01). Cellular immunity function and immuno regulatory factors (IL 2, IL 2R, interferon α) and NK cell activity were improved after treatment by Fuzheng anti cancer granula. Fuzheng anti cancer granula has a strong inhibiting and killing effect against MNK 45 poorly differentiated gastric cancer cells in vitro by changing the structure of cancer cells. In animal experiment Fuzheng anti cancer granula was also capable of inhibiting the growth of SGC 7901 in rats and could prolong the survival time. CONCLUSION Fuzheng anti cancer granula can suppress tumor growth, kill cancer cells, and regulate body immunity status. The clinical efficacy of the combination regimen is superior to chemotherapy and Fuzheng anti cancer granula alone.