To observe the clinical effects and safety of Xiaojin Capsule combined with surgical operation in the treatment of plasma cell mastitis in period of fistula. Methods:A total of 96 cases of patients with plasma cell mastitis in period of fistula who were treated in our hospital from March 2011 to April 2015 were selected and randomly divided into observation group and control group, with 48 cases in each group. The patients were treated with conventional surgery in the control group, while the observation group was treated with Xiaojin capsules on the basis of the control group. The rate of wound healing and the incidence of adverse events were observed in 7th days post operation. And the recurrence rate was followed up at 6th month, 12th month and 24th month after operation. Results:Two cases were lost follow up at the 12th month post operation in observation group, and 5 cases in 24th month, while only 1 case was lost follow up at the 12th month, and 3 cases at 24th month in the control group. The healing rate of the observation group was 979% on the 7th day after operation, which was significantly higher than that of the control group (P<005), while that of the control group was 854%. The recurrence rate of the observation group was respectively 0%, 43% and 70% on the 6th month, 12th month and 24th month after operation, which was significantly higher than that of the control group (P<005), while that of the control group was 83%, 170% and 222% respectively. No adverse reactions were observed directly related to the Xiaojin Capsule. Conclusion:Xiaojin capsule can significantly improve the wound healing rate, reduce the recurrence rate in the treatment of fistula stage plasma cell mastitis in the perioperative period, while its safety is favorable.