Objective:To evaluate to the efficacy and safety of Shenqi Fuzheng Injection (SFI) combined with chemotherapy in the treatment of acute leukemia (AL) by meta-analysis.Methods:PubMed,Cochrane library,Embase,SinoMed,China National Knowledge Infrastructure (CNKI),VIP Journal Integration Platform,Wanfang Database were searched from establishment to November 1,2018.The randomized controlled trials (RCTs) of SFI combined with chemotherapy in the treatment of AL were included.The Cochrane risk assessment form(RevMan 5.1) was used to evaluate the quality of included studies.Results:A total of 14 RCTs and 1,088 patients was included.The quality evaluation was mostly low risk or unclear.Meta-analysis showed that compared with chemotherapy alone,SFI combined with chemotherapy can improve the total clinical effective rate in patients with AL (RR=1.15,95％ CI:1.056-1.177;P=0.0001),and relieve adverse reactions caused by chemotherapy drugs,including infection (RR=0.561,95％ CI:0.397-0.792;P=0.001),nausea and vomiting (RR=0.662,95％ CI:0.524-0.835;P=0.001),bleeding (RR=0.548,95％ CI:0.39-0.768;P=0.0001),cardiotoxicity (RR=0.230,95％ CI:0.080-0.660;P=0.006) and hyperhidrosis (RR=0.348,95％ CI:0.208-0.581;P=0.0001).The incidence rates of adverse reactions in SFI combined with chemotherapy group were significantly lower than that of the chemotherapy alone group (P＜0.01).Conclusions:Shenqi Fuzheng Injection combined with chemotherapy has good efficacy and safety for AL,and it can alleviate the adverse reactions caused by chemotherapy.However,subject to the limitations of the methodological quality of the literature,the conclusions of this study need to be further verified by large-scale and multi-center RCTs.