Abstract: OBJECTIVE To observe the efficacy and safety of rosiglitazone combined with anxue granules in the treatment of diabetic retinopathy (DR). METHODS 210 patients were randomly divided into three groups: Chinese medicine group， western medicine group and combination group. On the basis of regulating blood pressure， blood lipid， blood glucose and other routine treatment， rosiglitazone， anxue granules， rosiglitazone + anxue granules were taken orally by patients in three groups respectively for 60 days. The ophthalmic routine examination indexes (gray value of visual field， thickness of retina， thickness of macular fovea， volume of hemangioma， average defect of visual field and average photosensitivity)， hemodynamic indexes of central retinal artery peak systolic velocity (PSV)， end-diastolic velocity (EDV)， pulse index (PI)， resistance index (RI)， serum cytokines intercellular Adhesion factor-1 (ICAM-1)， endothelin-1 (ET-1)， transforming growth factor-β (TGF-β) and stromal cell derived factor-1 (SDF-1)， oxidative stress related indicators triacetate cellulose (TAC)， malondialdehyde (MDA)， lipid hydrogen peroxide (LHP) and total antioxidant capacity (TAOC) were observed before and after treatment. Total effective rate and incidence of adverse reactions were compared among the three groups. RESULTS 9 cases dropped off during the study. The total effective rate of combined group was 97.1%， higher than that of Chinese medicine group (76.1%) and western medicine group (76.9%) (P<0.05). There was no significant difference in the total effective rate between the Chinese medicine group and western medicine group (P>0.05). The ophthalmic routine examination， retinal central artery blood flow mechanics， serum cytokines and oxidative stress were significantly improved in the combined group than that of Chinese medicine group and western medicine group (P<0.05). The incidence of adverse reactions: Chinese medicine group was 1.5%)， lower than combined group (5.8%) and western medicine group (13.8%) (P<0.05). CONCLUSION Rosiglitazone combined with anxue granules is safe and effective in the treatment of DR， and it is worthy of clinical application.