Objective

2

To explore the effect and safety of

Yiqi Huayu Jiedu Decoction

（益气化瘀解毒方， YJD）combined with chemotherapy in the treatment of stage Ⅳ gastric cancer （GC） with spleen-stomach

qi

deficiency and internal obstruction of stasis toxin syndrome， and discuss the possible mechanism.

Methods

2

Seventy patients with stage Ⅳ GC and spleen-stomach

qi

deficiency and internal obstruction of stasis toxin were randomly divided into treatment group and control group， with 35 cases in each group. The control group was given conventional chemotherapy only， and 21 days was a chemotherapy cycle； the treatment group was given oral YJD on the basis of chemotherapy， once a day. Both groups were treated with two cycles of chemotherapy. The levels of serum inflammatory factors including interleukin 1β （IL-1β）， interleukin 2 （IL-2）， interleukin 12p70 （IL-12p70）， interleukin 4 （IL-4）， interleukin 6 （IL-6）， interleukin 8 （IL-8）， interleukin 10 （IL-10）， tumor necrosis factor alpha （TNF-α）， and interferon gamma （IFN-γ）， the levels of tumor markers including carcinoembryonic antigen （CEA） and carbohydrate antigen 199 （CA199）， traditional Chinese medicine （TCM） symptom score regarding stomach pain， stomach bloating， anorexia， belching， acid reflux， feeling blocked when eating， vomiting， diarrhea， constipation， and fatigue， as well as Karnofsky performance status scale （KPS） score were detected before and after treatment. The objective efficacy， TCM syndrome effect and quality of life efficacy were judged after treatment， and the adverse events were recorded during treatment for safety evaluation. Pearson correlation analysis was used to analyze the correlation between serum inflammatory factors， tumor markers and KPS scores in gastric cancer patients in the treatment group.

Results

2

After treatment， the levels of IL-1β， IL-2， IL-12p70， TNF-α and IFN-γ in the treatment group significantly increased， while the levels of IL-4， IL-6 and IL-10， as well as the total TCM symptom score and score of symptoms except for constipation significantly decreased （

P

＜0.05 or

P

＜0.01） in the treatment group.The serum CEA and CA199 levels in both groups significantly decreased （

P

＜0.05） after treatment. There was no significant difference in objective response rate （ORR） between the treatment group （34.29%） and the control group （20.59%，

P

＞0.05）. The total effective rate regarding the improvement of TCM symptom and the quality of life in the treatment group was both 65.71%， significantly higher than those of the control group （26.47% and 32.35% respectively，

P

＜0.05）. There was no significant difference between groups in terms of leukopenia， thrombocytopenia， anemia， abnormal liver function， and abnormal renal function （

P

＞0.05）. Correlation analysis showed that in the treatment group the KPS score was positively correlated to IL-1β， TNF-α， and IFN-γ， correlation coefficients being 0.78， 0.88， and 0.77 respectively， while negatively correlated to IL-12p70， IL-8， and IL-10， correlation coefficients being -0.82， -0.95， and -0.88 respectively.

Conclusion

2

YJD in combination with chemotherapy can significantly improve the clinical symptoms and quality of life and is safe in treating stage Ⅳ GC patients with spleen-stomach

qi

deficiency and internal obstruction of stasis toxin. The mechanism may be related to the regulation of imbalanced inflammatory factors and the improvement of the immune microenvironment.