探讨口服中药康复新液联合曲安奈德局部注射治疗肉芽肿性乳腺炎的疗效，以及治疗后，对免疫组化指标Ki-67抗原的影响。

选取2011年6月至2016年10月，于石家庄市第四医院被确诊为肉芽肿性乳腺炎的104例患者为研究对象。按照就诊顺序的奇、偶数，将其随机纳入研究组(n＝50，采用口服康复新液联合曲安奈德于病灶组织局部注射方案治疗)与对照组(n＝54，单纯采用曲安奈德于病灶组织局部注射治疗方案)。统计学分析2组肉芽肿性乳腺炎患者的治疗疗效，以及治疗前、后肉芽肿性乳腺炎病灶活组织病理学检查的免疫组化指标Ki-67抗原表达变化。2组患者年龄、病程、病情严重程度、生活习惯等一般临床资料比较，差异均无统计学意义(P>0.05)。本研究遵循的程序符合病例收集医院人体试验委员会所制定的伦理学标准，得到该委员会批准，分组征得受试对象本人的知情同意，并与之签署临床研究知情同意书。

研究组采用口服康复新液联合曲安奈德局部注射方案治疗3周后，乳房疼痛评分、局部肿块直径变化评分、局部皮肤状况评分等疗效指标，均较对照组具有显著优势，2组比较，差异均有统计学意义(t＝5.033，P<0.001；t＝6.102，P<0.001；t＝4.317，P＝0.003)。治疗前，2组患者肉芽肿性乳腺炎病灶免疫组化指标Ki-67抗原高表达率(Ki-67抗原阳性细胞所占百分率≥20%)与低表达率(Ki-67抗原阳性细胞所占百分率<20%)构成比比较，差异无统计学意义(χ²＝0.388，P＝0.533)。治疗3周后，研究组肉芽肿性乳腺炎病灶组织免疫组化指标Ki-67抗原低表达率为80.0%(40/50)，显著高于对照组的55.6%(36/54)，2组比较，差异有统计学意义(χ²＝7.050，P＝0.008)。

采取口服康复新液联合曲安奈德进行病灶组织局部注射治疗肉芽肿性乳腺炎，可有效降低炎性细胞增殖活性，提高疗效。但是，该治疗方案是否值得临床推广、应用，则尚需多中心、大样本随机对照试验进一步研究、证实。

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.