To study curative effects of oral Chinese medicine of kangfuxin solution combined with triamcinolone acetonide locally injection in treatment of local lesion in granulomatous mastitis, and its influences on the immunohistochemistry index of Ki-67 antigen after treatment.

From June 2011 to October 2016, a total of 104 cases of patients who were diagnosed as granulomatous mastitis and were treated in Fourth Hospital of Shijiazhuang were selected as research subjects. According to their odd and even number of doctors′office visiting, they were randomly divided into research group (n=50, treated by kangfuxin solution combined with triamcinolone acetonide locally injection), and control group (n=54, only treated by triamcinolone acetonide locally injection). Statistical methods were used to analyze the curative effects of patients with granulomatous mastitis between two groups, as well as influences on the immunohistochemistry index of Ki-67 antigen after treatment. There were no significant differences between two groups among age, course of disease, severity degree of disease and living habits (P>0.05). The study protocol was approved by the Ethical Review Board of Investigation in Human Being of cases collection hospital. Informed consent was obtained from each participant.

Indicators of efficacy among breast pain score, local tumor diameter change score, skin condition score in research group after treatment for 3 weeks by kangfuxin solution combined with triamcinolone acetonide locally injection all were significantly better than those in control group after treatment for 3 weeks only by triamcinolone acetonide locally injection, and all the differences were statistically significant (t=5.033, P<0.001; t=6.102, P<0.001; t=4.317, P=0.003). Before treatment, there was no statistical difference between two groups in the constitute ratio of high and low expression rate of Ki-67 (percentage of Ki-67 antigen positive cells ≥20% and <20%) in granulomatous mastitis lesions (χ²=0.388, P=0.533). After treatment for 3 weeks, the low expression rate of Ki-67 antigen in the granulomatous mastitis lesions of research group was 80.0% (40/50), which was higher than that of control group 55.6% (36/54), and the difference was statistically significant (χ²=7.050, P=0.008).

Curative effect of kangfuxin solution combined with triamcinolone acetonide locally injection in treatment of granulomatous mastitis is better than that treatment only by triamcinolone acetonide locally injection in this study, and it can reduce the proliferation of inflammatory cells activity. But whether this combination strategy is worthy of clinical application, multi-center and large-sample randomized controlled trial will be needed to confirm.