Abstract： Objective： To observe the clinical effect of Zhibai Dihuang tang combined with artificial tears for dry eyes induced by diabetes mellitus of yin deficiency and dryness-heat type and its possible mechanism. Methods ： A total of 60 cases of patients with dry eyes induced by diabetes mellitus of yin deficiency and dryness-heat type were selected anddivided into the control group and the observation group according to the random number table method， 30 cases in each group. The control group was given sodium hyaluronate eye drops，and the observation group was additionally given Zhibai Dihuang tang based on the treatment of the control group. Before and after treatment，the score of subjective symptoms in dry eye questionnaire，the height of lacrimal river，tear break-up time，and tear secretion volume were compared between the two groups. The levels of tumor necrosis factor-α(TNF-α)，interleukin-1α(IL-1α)，interleukin-6(IL-6)，and interleukin-8(IL-8) in tear were detected before and after treatment. Results：Before treatment，there was no significant difference being found in the comparison of the score of subjective symptoms between the two groups(P＞0.05). After treatment， the scores of subjective symptoms including dry sensation， burning sensation， and fatigue in the two groups were decreased when compared with those before treatment，and the scores of dry sensation and burning sensation in the observation group were lower than those in the control group， the difference being significant(P＜0.05). Before treatment， when compared the height of lacrimal river，tear break-up time，and tear secretion volume between the two groups，there was no significance in the difference(P＞0.05). After treatment，tear break-up time in the observation group was prolonged when compared with that before treatment，and higher than that in the control group，the difference being significant(P＜0.05). Before treatment， there was no significant difference being found in the comparison of the levels of inflammatory factors in tear between the two groups(P＞0.05). After treatment， the levels of TNF- α， IL- 1α， IL- 6， and IL- 8 in tear in the observation group were decreased when compared with those before treatment， and the levels of TNF- α， IL- 1α，and IL- 6 in the observation group were lower than those in the control group，the difference being significant(P＜0.05). Conclusion：In the treatment of dry eyes induced by diabetes mellitus of yin deficiency and dryness-heat type，the therapy of Zhibai Dihuang tang combined with artificial tears can more effectively improve symptoms of dry eyes than simple artificial tears，which is possibly related to the decrease of the expression of inflammatory factors in tear.