Abstract: OBJECTIVE To observe the curative effect of Dahuang Lidan tablets on patients with non-alcoholic fatty liver disease in damp-heat accumulation pattern， and to explore its effects on serum interleukin-1 receptor antagonist (IL-1RA)， interleukin (IL)-1β， IL-18 levels and intestinal flora. METHODS The enrolled cases were 86 patients with non-alcoholic fatty liver disease， admitted to Gansu Provincial Hospital of TCM from June 2017 to April 2019. They were divided into the control group and the observation group according to the random number table， with 43 cases in each group. The two groups were given conventional treatment measures according to the guidelines. The control group was given Silybin capsules， 3 times a day， 4 tablets each time. The observation group was treated orally with Dahuang Lidan tablets， 2 tablets each time， 3 times a day， based on the treatment of the control group. Both groups were treated continuously for 12 weeks. The liver function， blood lipid levels， damp-heat accumulation syndrome score， clinical efficacy， serum IL-1RA， IL-1β， IL-18 levels， and changes of intestinal flora were compared between the two groups. RESULTS After treatment， the aspartate aminotransferase (AST)， alanine aminotransferase (ALT)， low-density lipoprotein cholesterol (LDL-C)， total cholesterol (TC)， triglycerides (TG)， and damp-heat accumulation syndrome score in the observation group were significantly lower than those in the control group， while its high-density lipoprotein cholesterol (HDL-C) was notably higher than that of the control group (P<0.01). The total effective rate of the observation group was 93.02%， and the control group was 74.42%. As for the total effective rate， the observation group was conspicuously higher than that of the control group (P<0.01). After treatment， the serum IL-1RA level of the observation group was significantly higher than that of the control group. The levels of IL-18， IL-1β were remarkably lower than those of the control group (P<0.05). The numbers of Bifidobacterium and Lactobacillus in the observation group were strikingly higher than those in the control group after treatment， and the number of Escherichia coli was prominently lower than that of the control group (P<0.05). There was no conspicuous difference in the changes of Bifidobacterium， Lactobacillus and Escherichia coli before and after treatment in the control group (P>0.05). There was no significant difference in the changes of Enterococcus between the two groups before and after treatment (P>0.05). CONCLUSION Dahuang Lidan tablets have a definite effect in treating non-alcoholic fatty liver disease with accumulation of damp-heat syndrome. Its mechanism may be related to the regulation of serum IL-1RA， IL-1β， IL-18 levels， and intestinal flora.