Abstract: Objective　To explore the clinical effect and safety of Jiuyi Dan on the wound repair of refractory non-puerperal mastitis (RNPM). Methods　Patients with RNPM who were treated with incision and debridement from December 2020 to December 2021 were divided into observation group and control group according to the postoperative treatment method. The control group was given routine dressing change, and the observation group was given the traditional Chinese medicine preparation Jiuyi Dan for external use on the basis of the control group. The effect and safety of the two groups on the postoperative wound cavity repair of patients with RNPM were retrospectively analyzed. Results　A total of 78 patients were included, including 38 cases in the observation group and 40 cases in the control group. There was no significant difference in wound volume between the two groups at 1 and 3 weeks after operation (P>0.05). Compared with 1 week after operation, the volume reduction of wound cavity at 3 weeks after operation was (23.59±14.19) mL and (16.96±10.78) mL in the observation group and the control group, respectively, and the difference between the two groups was statistically significant (t=2.06, P<0.05). The volume of wound cavity decreased more significantly in the observation group (F=4.22, P=0.04, partial η2=0.07). The wound healing time ≤2 months accounted for 68.42% (26/38) and 40% (16/40) in the observation group and the control group, respectively, and the wound healing time >2 months accounted for 31.58%(12/38) and 60%(24/ 40) in the observation group and the control group, respectively, with a statistically significant difference (χ2=6.33, P=0.01). The score of breast shape 6 months after operation in the observation group was 4.55±2.31, which was higher than that in the control group (3.38±1.98), and the difference between the two groups was statistically significant (t=2.17, P=0.03). There was no significant difference in liver and kidney function between the two groups before and after treatment(P>0.05). Conclusion　The external application of Jiuyi Dan can effectively promote the repair of wound cavity tissue after operation of RNPM, protect the appearance of breast, and has a certain safety.

Key words: Refractory non-puerperal mastitis, 　Jiuyi Dan, 　Traditional Chinese medicine therapy, 　Wound healing