Objective To evaluate the effect of Yiqi Jianpi Huaji Formula on regulation of immunity indexes of peripheral blood in gastric cancer patients differentiated as qi deficiency and blood stasis syndrome undergoing chemotherapy.
Methods A design of multi-centered, randomized, double-blind, single-dummy, paralleled, placebo-controlled was adopted to collect the data of 38 gastric cancer patients differentiated as qi deficiency and blood stasis syndrome undergoing chemotherapy, and they were divided into two groups. The treatment group(n=19) was orally administered Yiqi Jianpi Huaji Formula granules based on chemotherapy of docetaxel plus cisplatin(DC), while the control group(n=19) was given Yiqi Jianpi Huaji granules placebo based on DC chemotherapy. Both groups were given one dose daily for 56 days. The change of ratios of CD4, CD8, NK cell count, TNF-α and IFN-γ in peripheral blood, toxic and side effects before and after treatment of two groups were compared.
Results In the treatment group, the ratios of CD4 and NK cells increased significantly after intervention of Yiqi Jianpi Huaji Formula (P < 0.05), and ratio of CD8 cells was lower than treatment before(P < 0.01). In the control group, ratio of CD4 cells was significantly decreased, and ratio of CD8 cells was higher than treatment before (P < 0.01), while ratio of NK cells was also decreased than treatment before (P < 0.05). Compared with before treatment, the level of TNF-α decreased and the level of IFN-γ increased in the treatment group after treatment (P < 0.01). The level of TNF-α in the control group after treatment was significantly higher than that before treatment (P < 0.01), while the level of IFN-γ before and after treatment had no statistically significant difference (P>0.05). After treatment, the ratios of CD4, CD8 and NK cells and the levels of TNF-α and IFN-γ in peripheral blood showed significant difference between the two groups (P < 0.01). After the second round of chemotherapy, there was a statistically significant difference in the toxic and side effects scores between the treatment group and the control group (P < 0.05).
Conclusion Yiqi Jianpi Huaji Formula can regulate the ratios of CD4, CD8, NK cells, and TNF-α, IFN-γ levels in peripheral blood of patients differentiated as qi deficiency and blood stasis syndrome undergoing DC chemotherapy, also alleviate the toxic and side effects after chemotherapy, and shows an advantage of improving the cellular immune function.
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