ObjectiveTo systematically review the effectiveness and safety of Kanglaite combined with gemcitabine in treating patients with advanced non-small cell lung cancer (NSCLC). MethodsThe randomized controlled trials (RCTs) about Kanglaite ombined with gemcitabine treating advanced NSCLC was retrieved in PubMed, EMbase, The Cochrane Library (Issue 9, 2013), CBM, CNKI, VIP, and WanFang Data from the dates of their establishment to September 2013. Literature screening according to the inclusion and exclusion criteria, data extraction and methodological quality assessment were completed by two reviewers independently. Meta-analysis was then conducted using RevMan 5.2 software. ResultsA total of seven RCTs involving 506 patients were finally included. The results of meta-analysis indicated that:a) Kanglaite injection combined with gemcitabine chemotherapy increased short-term effectiveness (OR=1.85, 95%CI 1.29 to 2.65, P=0.000 8), patients' quality of life (OR=3.02, 95%CI 1.90 to 4.78, P < 0.000 1), and immune function (MD=0.64, 95%CI 0.31 to 0.97, P=0.000 1); and reduced the incidences of leukopenia decrease (OR=0.30, 95%CI 0.19 to 0.47, P < 0.000 01), nausea and vomiting (OR=0.49, 95%CI 0.34 to 0.73, P=0.000 3), bone marrow suppression (OR=0.27, 95%CI 0.16 to 0.45, P < 0.000 01), and liver and renal impairments (OR=0.43, 95%CI 0.28 to 0.68, P=0.000 3), all with significant differences. b) Both groups were alike in reducing thrombocytopenia (OR=0.67, 95%CI 0.40 to 1.14, P=0.14) without significant differences. ConclusionApplying Kanglaite injection combined with gemcitabine in treating patients with advanced NSCLC could increase short-term effectiveness, improve patients' quality of life and immune function; and reduce the incidences of adverse reaction caused by chemotherapy. However, it has no obvious advantage in reducing thrombocytopenia. Due to the limited quantity and quality of the included studies, more larger sample size, multicenter, high quality RCT are needed to verify the above conclusion.