Objective: To observe the effects of Zhengan Xifengtang on interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) in patients with diabetes mellitus complicated with acute cerebral infarction

and investigate its mechanism of action. Method: The 80 patients within 72 h of diabetes mellitus with cerebral infarction were randomly divided into treatment group (40 cases) and control group (40 cases). Patients in treatment group orally took Zhengan Xifengtang on the basis of treatment in control group. Traditional Chinese medicine (TCM) syndrome scores and national institutes of health stroke scale (NIHSS) scores were recorded and the serum levels of IL-6 and TNF-α were detected at different stages of treatment (day 0

day 7 and day 14). Result: The improvement of TCM symptoms in treatment group was significantly better than that in control group after treatment (P<0.05). The NIHSS scores of treatment group were significantly lower than those of control group after treatment (P<0.05). On day 7 after treatment

the levels of IL-6 and TNF-α were decreased in both groups

and the levels in treatment group were significantly lower than those in control group (P<0.05). There was no significant difference in the levels of and TNF-α between two groups on day 14 after treatment. Conclusion: Zhengan Xifengtang can significantly improve TCM symptoms and neurological deficits of patients with diabetes mellitus complicated with acute cerebral infarction and reduce the inflammatory response.