Objective:To observe the clinical effects of hot-wet compression with Xiaohua ointment for acne mastitis in mass stage and its impacts on humoral immune function and inflammation.Methods:85 cases of patients with acne mastitis in mass stage treated in our hospital from January 2018 to January 2019 were selected as the research objects and randomly divided into control group (42 cases) and observation group (43 cases). The control group taken Tuoli xiaodu powder and external use of purple detumescence cream, and the observation group received hot-wet compression with Xiaohua ointment additionally. All treated for 30 days. The clinical efficacy, symptom scores, breast mass size, humoral immune indexes, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were compared, and the adverse reactions were recorded.Results:After treatment, the humoral immune indexes of the two groups had no significant change ( P>0.05), but the pain score, breast tumor size, mass score, CRP and ESR were significantly decreased than those before treatment ( P<0.05); compared with the control group, the pain score, breast tumor size and mass score in the observation group were significantly lower than those in the control group ( P<0.05). The total effective rate of the observation group was 83.7%, which was significantly higher than 59.5% of the control group ( P<0.05). There were no obvious adverse reactions in both groups. Conclusions:Hot-wet compression with Xiaohua ointment is effective and safe for patients with acne mastitis in mass stage, and could improve their inflammation.