ObjectiveTo systematically evaluate the efficacy and safety of budesonide/formoterol combined with tiotropium versus budesonide/formoterol alone for Chinese patients with COPD. MethodsWe electronically searched databases including PubMed, EMbase, The Cochrane Library (Issue 3, 2015), CNKI, VIP and WanFang Data to collect randomized controlled trials (RCTs) about budesonide/formoterol combined with tiotropium vs. budesonide/formoterol alone for Chinese COPD patients from inception to March 2015. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was conducted by RevMan 5.3 software. ResultsA total of 15 studies involving 1123 Chinese patients were included. The results of meta-analysis showed that, compared with the budesonide/formoterol alone group, the budesonide/formoterol plus tiotropium group could significantly improve the levels of FEV1 (MD=0.19, 95%CI 0.12 to 0.25, P<0.00001), FVC (MD=0.35, 95%CI 0.14 to 0.57, P=0.001), FEV1% (MD=5.96, 95%CI 4.48 to 7.43, P<0.00001), FEV1% pred (MD=6.82, 95%CI 2.21 to 11.43, P=0.004), FEV1/FVC (MD=7.72, 95%CI 5.69 to 9.75, P<0.00001), mMRC (MD=-0.43, 95%CI -0.52 to -0.33, P<0.00001), CAT (MD=-1.45, 95%CI -2.26 to -0.64, P=0.0005), SGRQ (MD=-7.05, 95%CI -9.16 to -4.94, P<0.00001) and 6MWT (MD=32.52, 95%CI 16.68 to 48.37, P<0.00001). While there was no significant difference in adverse reaction rates between the two groups (OR=1.77, 95%CI 0.79 to 3.98, P=0.16). ConclusionCurrent evidence shows that budesonide/formoterol plus tiotropium can improve lung function and clinical symptom in Chinese patients with COPD. Due to the limited quality and quantity of included studies, more high quality studies are needed to verify the above conclusion.