Objective To systematically evaluate the efficacy and safety of tiotropium plus budesonide/formoterol compared with tiotropium in Chinese patients with chronic obstructive pulmonary disease (COPD). Methods PubMed (from 1980 to March, 2015), Wiley Online Library (from 1990 to March, 2015), Elsevier (from 1990 to March, 2015), CNKI(from 1990 to March, 2015), VIP(from 1990 to March, 2015) and WanFang Data(from 1990 to March, 2015) were searched for randomized controlled trials (RCTs) of tiotropium plus budesonide/formoterol compared with tiotropium in treating Chinese patients with COPD from the establishment of the database to March 2015. The quality of included studies was assessed according to Cochrane Methods 5.1 for Systematic Review, and Meta-analysis was conducted by RevMan 5.3 software. Results Atotal of 9 studies involving 503 patients were included. Compared with the tiotropium therapy group, tiotropium plus budesonide/formoterol in treating Chinese patients with COPD can more significantly improve FEV1 (MD=0.10, 95%CI 0.05 to 0.15, P<0.000 01), FEV1%pred (MD=4.27, 95%CI 2.44 to 6.09, P<0.000 01), FEV1/FVC (MD=3.48, 95%CI 3.21 to 3.74, P<0.000 01), mMRC (MD=-0.27, 95%CI -0.38 to -0.17, P<0.000 01), CAT (MD=-0.91, 95%CI -1.74 to -0.08, P=0.03), 6MWT (MD=27.64, 95%CI 11.76 to 37.53, P<0.000 01) and the frequency of repeated exacerbations (OR=0.25, 95%CI 0.08 to 0.76, P=0.01) while no significant difference was found between two groups in SGRQ (MD=-5.11, 95%CI -11.57 to 1.36, P=0.12). There was no significant differences in adverse reaction rates (OR=1.33, 95%CI 0.65 to 2.73, P=0.44) between the tiotropium plus budesonide/formoterol group and the control group. Conclusions Tiotropium plus budesonide/formoterol is effective in treating Chinese patients with COPD. It can effectively improve treatment efficiency and does not increase the incidence of adverse drug reactions. However, due to the limitation of both quantity and quality of included studies, this conclusion should be further confirmed by more high quality and large sample studies.