To evaluate the efficacy of ShenQi Fuzheng Formula and Chinese patent medicine combined with chemotherapy drugs in the treatment of malignance cancer.Methods:Through computer search of domestic databases such as CNKI,VIP database,Wanfang database and foreign databases such as PubMed,OVID,EmBase,etc.,we searched for Chinese and English literature on randomized controlled trials of Shenqi-based Fuzheng Formula in the treatment of malignant tumors.The retrieval time was nearly 5 years.RevMan5.3 software was used to extract relevant data from selected documents,to analyze the efficacy of Fuzheng Formula,and to compare the differences between the test group and the control group.Results:A total of 18 papers were included,totaling 1 724 patients.The results showed that the test group was superior to the control group in the whole course of treatment of malignant tumors ［RR=1.46,95%CI(1.35~1.59),P<0.000 01］.Conclusion:ShenQi Fuzheng Formula combined with chemotherapy in the treatment of malignant tumors can inhibit tumor growth,enhance immune function,improve quality of life and reduce the incidence of adverse reactions.The application of this method can effectively treat malignant tumors.