BACKGROUND:To observe the pathological changes of cornea and to clarify the effect Shumu Decoction on the cornea in diabetic dry eye.METHODS:The study assessed 200 eyes of 100 patients with diabetic dry eye.The treatment group 50 patients(100 eyes) and the control group 50 patients(100 eyes). The control group was treated with sodium hyaluronate eye drops. On the basis of the control group, the treatment group was treated by oral administration of Shumu Decoction.All participants underwent the examination of laser confocal microscope to obtain the image of cornea which were used to evaluate the differences between the two groups before and after treatment.RESULTS:After treatment,The corneal epithelial cell density in the treatment group was significantly higher than that in the control group(P <0.05) .The cell area of the two groups increased compared with that before treatment, but the area in the control group was significantly larger than that in the treatment group (P<0.05).The number of Langerhans cells in the control group were significantly higher than that in the treatment group(P<0.05).The morphology of Langerhans cells was characterized by large area and pseudopodia in the control group.The density, length of central corneal nerve fibers in the two groups were reduced compared to before treatment, but the decrease of nerve fiber in the control group was more obvious than that in the treatment group(P<0.05), and the morphology of nerve fibers was obvious change in the control group(P<0.05).At 4 weeks' treatment,the corneal endothelial cells showed morphological abnormality, there was significant difference in the ratio of endothelial cell hexagon between the two groups, and the corneal thickness increased significantly in the control group(P<0.05).CONCLUSION:Shumu Decoction can delay the loss of corneal cells and nerve fibers and restore the normal function of cornea.Those changes may alleviate the symptoms of patients with diabetic dry eye