OBJECTIVE:To evaluate the clinical efficacy and safety of Shenqi fuzheng injection combined with chemotherapy in the treatment of colorectal cancer.METHODS:Retrieved from PubMed,EMBase,Clinical Trials,Cochrane Library,CJFD,CBM,Wanfang database and VIP,RCTs about Shenqi fuzheng injection combined with chemotherapy (trial group) vs.chemotherapy alone (control group) in the treatment of colorectal cancer were included.Meta-analysis was performed by Rev Man 5.3 statistical software after data extraction and quality evaluation with Cochrane system evaluator manual.RESULTS:A total of 25 RCTs were included,involving 1 987 patients.Results of Meta-analysis showed that objective remission rate of trial group was significantly higher than control group [RR=1.19,95％ CI (1.02,1.39),P=0.02];the improvement of survival quality was significantly better than control group [RR=1.72,95％CI(1.49,1.99),P＜0.001];CD4VCD8+ was significantly higher than control group [MD=0.40,95％ CI (0.29,0.50),P＜0.001];the incidence of gastrointestinal reaction was significantly higher than control group [RR=0.59,95％CI(0.52,0.68),P＜0.001];the incidence of liver and renal injury was significantly lower than control group [RR=0.52,95％CI(0.41,0.67),P＜0.001],with statistical significance.CONCLUSIONS:Shenqi fuzheng injection combined with chemotherapy can improve objective remission rate of colorectal cancer patients,survival quality and immune function,and reduce the occurrence of toxic reation.