Objective: To observe the regulatory effect of Bushen Jianpi Recipe (BSJPR) on cellular immunity the of primary liver cancer patients of Gan-Shen yin-deficiency and Pi qi-deficiency syndrome type after intervention therapy.

Methods: According to the multi-center randomized controlled principle, 117 patients after transcatheter arterial chemoembolization (TACE) were assigned to two groups, 60 in the treated group and 57 in the control group, who were treated respectively with BSJPR and liver protecting remedy (silymarin and vitamin c) for 12 weeks. Changes in TCM syndrome, quality of life (QOL), immediate effect on tumor size and survival time were observed. Meantime, the cellular immune function was also observed, including the T lymphocyte response determined by 3H-TdR, expression of MHC class I/II and B7 molecule detected by FACS, and interleukin 10 and 12 (IL-10, IL-12), interferon-gamma (IFN-gamma) tested by ELISA.

Results: In the treated group after treatment, the efficacy for improving TCM syndrome reached 73.33% (44/60 cases), their half-year survival rate being 83.33% (50/60 cases); while those in the control group were 52.63% (30/57 cases) and 70.18% (40/57 cases) respectively, significant difference was shown between the two groups (P <0.05). The patients' QOL was improved in the treated group after treatment, with no obvious adverse reaction. However, the clinical benefit rate in the control group (92.7%, 51/55 cases) was higher than that in the treated group (78.0%, 46/59 cases, P =0. 035). Laboratory examination showed increases of MHC class II (CD14+/HLA-DR) expression on monocyte surface as well as IFN-gamma and IL-12 production in the treated group.

Conclusion: Using BSJPR together with TACE could enhance patients' cellular immune function to elevate the clinical curative effect on primary liver cancer.

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