AIM:To observe the clinical effects of pancreatic kininogenase for treatment of early diabetic retinopathy(DR). METHODS:Totally 230 cases (395 eyes) of DR (Ⅰ-Ⅲ period) patients were randomly divided into two groups. On the basis of conventional therapy, the treatment group of 120 cases (210 eyes) were treated with pancreatic kininogenase for 12 months. The control group of 110 cases (185 eyes) received conventional therapy for 12 months. The changes in fundus, fluorescence fundus angiography (FFA) and vision were observed before and after treatment. RESULTS:The fundus improvement in treatment group was significantly higher than that in control group, the visual acuity improved (P<0.05). CONCLUSION: Pancreatic kininogenase for treatment of early DR is effective, which has positive significance for early DR patients.