Objective

2

To evaluate the clinical effect of

Modified Sijunzi Decoction

（四君子汤加减， MSD） combined with chemotherapy for advanced gastric cancer patients with spleen deficiency pattern， and to explore the factors affecting the prognosis of advanced gastric cancer.

Methods

2

A Concurrent ambispective cohort study was designed， and 104 patients with advanced （ⅢB-Ⅳ） gastric cancer were collected. According to the exposure factors， the patients receiving only chemotherapy were classified into chemotherapy group （30 cases）， the patients taking oral MSD only （one dose daily） were in the MSD group （40 cases）， and those taking both chemotherapy and oral MSD （one dose daily） were in the combination group （34 cases）. The duration of treatment was 63 days. The Karnofsky functional status （KPS） score before and after treatment was measured； the overall survival was compared among groups； the time table method was used to calculate the 3-， 6-， 9- and 12-month survival rates； Kaplan-Meier method was used to estiamte the median survival time； univariate analysis and Cox multivariate regression model were used to analyze the independent prognostic factors of advanced gastric cancer patients with spleen deficiency pattern.

Results

2

The KPS scores were distributed differently among the three groups （χ

2

= 21.329，

P

＜0.001）. The KPS scores of the MSD group and the combination group were not significantly different （

P

= 0.905）， but both were higher than that of the chemotherapy group （MSD group

P

= 0.006， the combined group

P

= 0.01）. The median overall survival time of the chemotherapy group， MSD group and the combination group was 17， 20 and 36 months， respectively， with significant differences among the groups （

P

= 0.01）. The 3-， 6-， 9- and 12-month survival rates of the chemotherapy group were 86.60%， 66.70%， 58.25%， and 54.45%， respectively， while those in the MSD group were 87.50%， 75.00%， 68.75%， and 59.80%， and those in the combination group were 100%， 97.10%， 91.20%， and 82.10% correspondingly. Univariate analysis showed that age （

P

= 0.001）， TNM stage （

P

= 0.011）， degree of pathological differentiation （

P

= 0.011）， presence of other basic diseases （

P

= 0.033）， and treatment method （

P

= 0.010） were correlated with the prognosis of advanced gastric cancer patients with spleen deficiency. Multivariate Cox regression analysis showed that age， treatment method， TNM stage， and the presence of other basic diseases were independent factors， among which， age over 70， TNM stage Ⅳ and presence of other basic diseases were risk factors， while TCM combined with chemotherapy was a protective factor for prognosis of advanced gastric cancer patients with spleen deficiency.

Conclusion

2

MSD combined with chemotherapy is a protective factor for the prognosis of advanced gastric cancer patients with spleen deficiency pattern， correlated with a longer overall survival and higher quality of life. Age over 70 years old， TNM stage Ⅳ， and presence of other basic diseases are the risk factors.