OBJECTIVE： To systematically evaluate the efficacy and safety of duloxetine in the treatment of major depressive disorder （MDD）， and to provide evidence-based reference for clinical drug use. METHODS： Retrieved from the Cochrane Library， PubMed， Embase， CNKI databases， CBM and VIP databases， randomized controlled trials（RCTs） about duloxetine （trial group） versus placebo （control group）in the treatment of MDD were collected. After literature screening and data extraction， the quality of included studies was evaluated by using Cochrane systematic evaluator manual 5.1.0. Rev Man 5.3 software was used for Meta-analysis. RESULTS： A total of 8 RCTs were included， involving a total of 2 772 cases. Meta-analysis showed that the decrease of Montgomery-Asberg Depression Rating Scale [MD＝－3.97，95％CI（－4.71，－3.24），P＜0.000 01]， the decrease of Hamilton Anxiety Rating Scale[MD＝－2.12，95％CI（－3.66，－0.57），P＝0.007]， the decrease of Clinical Global Impression-Severity [MD＝－0.47，95％CI（－0.73，－0.21），P＝0.000 4]， the decrease of Clinical Global Impression-Improvement Scale [MD＝－0.58，95％CI（－0.92，－0.25），P＝0.000 6] and the decrease of Sheehan Disability Scale [MD＝－2.82，95％CI（－4.55，－1.09），P＝0.001] in trial group were significantly more than control group. The incidence of nausea， dry mouth， constipation， vomiting， dizziness， drowsiness， insomnia， hyperhidrosis and anorexia in the trial group was significantly higher than control group （P＜0.05）. There was no statistical significance in the incidence of serious ADR， diarrhea， headache and dyspepsia between 2 groups （P＞0.05）. CONCLUSIONS： Duloxetine shows significant therapeutic efficacy for the treatment of MDD， but it will increase the occurrence of common mild ADR.