OBJECTIVE  To observe the clinical efficacy of Erdong Xiaoke Formula in the treatment of type 2 diabetes dry eyes with yin deficiency and heat excess syndrome and its effect on serum interleukin 17 (IL-17) and interleukin 1β (IL-1β), and to explore the therapeutic mechanism of Erdong Xiaoke Formula.

  METHODS  110 cases of type 2 diabetes patients with dry eyes of yin deficiency and heat excess syndrome from Jiangsu Province Hospital of Chinese Medicine were enrolled and randomly divided into a treatment group and a control group, 55 cases each. 5 cases dropped out of the treatment group and 4 cases dropped out of the control group. The control group was given a basic hypoglycemic regimen combined with topical sodium hyaluronate eye drops. The treatment group was given Erdong Xiaoke Formula in addition to the treatment in the control group. The treatment course for both groups was 4 weeks. Changes in TCM syndrome scores of the two groups of patients were observed before and after treatment, and the clinical efficacy of TCM was evaluated. Blood glucose and pancreatic islet function-related indicators fasting blood glucose (FBG), fasting insulin (FINS), fasting C-peptide (FCP), postprandial 2 h blood glucose (PBG), insulin secretion function index (HOMA-β), insulin resistance index (HOMA)-IR), ocular surface indicators tear break up time (BUT), corneal sodium fluorescein staining (FL), Schirmer Ⅰ test (SⅠT), and inflammation-related indicators (IL-17, IL-1β) were detected. The occurrence of adverse reactions in the two groups of patients was observed during the treatment period.

  RESULTS  After treatment, the total scores of TCM syndromes in both groups were significantly reduced (P < 0.01), the treatment group was better than the control group (P < 0.01), and the total effective rate of TCM syndromes in the treatment group was higher than that of the control group (P < 0.01); SⅠT and BUT of patients in both groups increased significantly (P < 0.01), and the treatment group was better than the control group (P < 0.05, P < 0.01); the FL of patients in both groups significantly reduced (P < 0.01), and there was no significant difference between the groups; the serum IL-17 and IL-1β of the patients in the treatment group decreased significantly (P < 0.01), which was significantly better than that of the control group (P < 0.05). There were no significant changes in blood glucose and pancreatic islet function-related indicators in the two groups before and after treatment (P>0.05). During the treatment, no obvious adverse reactions were observed in the two groups.

  CONCLUSION  Erdong Xiaoke Formula can improve SⅠT, BUT, FL and eye symptoms in patients with diabetic dry eye, effectively treat diabetic dry eye, and reduce ocular surface inflammation. Its mechanism may be related to reducing serum inflammatory factors IL-17 and IL-1β.