Objective: To observe the clinical efficacy and adverse reactions of Yiqi Jiedu Xiaoai decoction and chemotherapy for advanced metastatic colorectal cancer (AMCC) with stagnated-toxin spleen deficiency syndrome. Method: A total of 62 patients with AMCC stagnated-toxin spleen deficiency syndrome in our department from January 2013 to June 2015 were selected and randomly divided into two groups. Patients in control group were treated with Sijunzi Tang combined with Irinotecan-folinic acid calcium salt hydrate-5-fluorouracil(FOLFIRI)chemotherapy

while the patients in observation group were treated with Yiqi Jiedu Xiaoai decoction combined with FOLFIRI chemotherapy. The clinical efficacy

progression-free survival

median overall survival time

tumor markers

quality of life and adverse reactions were followed up in both groups

and the difference in efficacy between two groups was compared. Result: After treatment

the disease control rate was 80.65% in observation group

higher than 54.84% in control group (P<0.05). After treatment

the median progression-free survival in observation group was 11.51 months

significantly longer than 8.77 months in control group (P<0.01)

and the median overall survival in observation group (25.54 months) was also significantly longer than that in control group (20.75 months) (P<0.01). In the follow-up of 30 patients with liver metastases

the control rate was 82.25% for 15 patients in observation group

significantly higher than 46.77% in control group (P<0.05). After treatment

the levels of CEA and CA199 in observation group were significantly lower than those in control group (P<0.05

P<0.01). In addition

the improvement of quality of life in observation group was significantly better than that in control group (P<0.05)

and the incidence of adverse reactions in was significantly lower than that of control group (P<0.05). There was no statistically significant difference in other indicators between two groups. Conclusion: The combination of Yiqi Jiedu Xiaoai decoction combined with FOLFIRI chemotherapy can increase the disease control rate in AMCC patients with liver metastases

prolong the survival period

reduce the adverse reactions caused by chemotherapy

reduce the blood tumor markers and improve the quality of life for patients with advanced metastatic colorectal cancer with stagnated-toxin spleen deficiency.