RESUMO
OBJECTIVE:To evaluate therapeutic efficacy and safety of Aidi injection combined with S-1 for advanced gastric cancer systematically,and to provide evidence-based reference. METHODS:Retrieved from CJFD,Wanfang database,VIP, CBM,Cochrane Library,PubMed and EMBase,randomized controlled trials(RCTs)about Aidi injection combined with S-1(tri-al group) vs. S-1 alone (control group) for advanced gastric cancer were collected. Meta-analysis was conducted by Rev Man 5.3 software after data extraction and quality evaluation by risk bias evaluation tool of Cochrane Handbook Version 5.1.0. RESULTS:A total of 8 RCT were included,involving 690 patients. Results of Meta-analysis showed that there was no statistical significance in therapeutic efficacy of solid tumor between 2 groups [OR=1.19,95%CI(0.88,1.61),P=0.26]. The improvement rate of survival quality[OR=3.62,95%CI(2.48,5.30),P<0.001],immunoglobulin level [CD3:SMD=1.31,95%CI(1.06,1.56),P<0.001;CD4:SMD=1.71,95%CI(1.38,2.04),P<0.001;CD8:SMD=-1.46,95%CI(-1.68,-1.23),P<0.001;CD4/CD8:SMD=1.45,95%CI(1.14,1.76),P<0.001] in trial group was significantly higher than control group. The incidence of leukopenia [RR=0.52,95%CI (0.40,0.68),P<0.001],thrombocytopenia [RR=0.49,95%CI(0.36,0.67),P<0.001] and gastrointestinal disorder [RR=0.56,95%CI(0.43,0.71),P<0.001] in trial group were significantly lower than control group,with statistical significance. CONCLUSIONS:Compared to S-1 alone,S-1 combined with Aidi injection can not significantly improve therapeutic efficacy of solid tumor therapy, but can improve survival quality and immunity of patients,as well as reduce the occurrence of ADR.