ABSTRACT: BACKGROUND:Xiao-ai-ping injection (XAPI), as patented Chinese medicine, has shown promising outcomes in non-small-cell lung cancer (NSCLC) patients. This meta-analysis investigated the efficacy and safety of XAPI in combination with platinum-based chemotherapy. METHODS:A comprehensive literature search was conducted to identify relevant studies in Pubmed, EMBASE, the Cochrane Library, Chinese National Knowledge Infrastructure, Wangfang Database, VIP Database, and Chinese Biology Medical Database from the date of their inception to September 2018. The RevMan 5.3 software was applied to calculate the risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI). RESULTS:We included and analyzed 24 randomized controlled trials. The meta-analysis showed that XAPI adjunctive to platinum-based chemotherapy had better outcomes in objective tumor response rate (ORR) (RR: 1.27, 95% CI, 1.14-1.40); improved Karnofsky performance scores (KPS) (RR: 1.70, 95% CI, 1.48-1.95); reduction in occurrence of grade 3/4 leukopenia (RR: 0.49, 95% CI, 0.38-0.64), anemia (RR: 0.63, 95% CI, 0.46-0.87) and thrombocytopenia (RR: 0.53, 95% CI, 0.38-0.73), nausea and vomiting (RR: 0.57, 95% CI, 0.36-0.90); and enhanced immune function (CD8+ [MD: 4.96, 95% CI, 1.16-8.76] and CD4+/CD8+ [MD: 2.58, 95% CI, 1.69-3.47]). However, it did not increase dysregulated liver and kidney function, diarrhea, constipation, and fatigue. Subgroup analysis of ORR and KPS revealed that dosage, treatment duration, and methodological quality did not affect the outcome significantly. CONCLUSIONS:Our meta-analyses demonstrated that XAPI in combination with platinum-based chemotherapy had a better tumor response, improved the quality of life, attenuated adverse side effects, and enhanced immune function, which suggests that it might be used for advanced NSCLC. Moreover, low dosage (