Abstract: Objective: To observe the clinical effect of Xiaoru Sanjie Decoction combined with surgery for non-puerperal mastitis (NPM) with stagnated heat in the liver meridian syndrome. Methods:A total of 96 cases of NPM patients with stagnated heat in the liver meridian syndrome were selected and divided into the treatment group and the control group according to the random number table method,with 48 cases in each group. Both groups were given surgery;after surgery,the control group was treated with Cefuroxime Sodium for Injection,and the treatment group was additionally treated with Xiaoru Sanjie Decoction based on the treatment of the control group. Both groups were followed up for 6 months. The clinical effects,as well as traditional Chinese medicine (TCM) syndrome scores,levels of inflammatory indicators [interleukin- 6 (IL-6), tumor necrosis factor- α (TNF- α), and C-protein reaction (CRP)], and recurrence rates were compared between the two groups. Results:The total effective rate of 15 days after surgery was 97.92% in the treatment group and 95.83% in the control group,and the comparison showed no significance in the difference (P>0.05). The cure rate was 54.17% in the treatment group,higher than that of 31.25% in the control group,the difference being significant (P<0.05). The TCM syndrome scores in the two groups were decreased when compared with those 1 day after surgery,and the score in the treatment group was lower than that in the control group,differences being significant (P<0.05). The levels of IL-6,TNF-α,and CRP in serum in the two groups were decreased when compared with those 1 day after surgery,and the levels of IL-6, TNF- α, and CRP in serum in the treatment group were lower than those in the control group, differences being significant (P<0.05). During the 3 months of follow-up,there was no recurrence in the treatment group, and the recurrence rate was 2.17% in the control group, there being no significance in the difference (P>0.05). During the 6 months of follow-up, the recurrence rate was 2.13% in the treatment group,lower than that of 13.04% in the control group,the difference being significant (P<0.05). Conclusion: In the treatment of NPM with stagnated heat in the liver meridian syndrome, the additional application of Xiaoru Sanjie Decoction based on surgery can effectively relieve symptoms and inflammatory responses,and reduce recurrence rates.