目的 观察消乳散结胶囊联合甲泼尼龙治疗肉芽肿性小叶乳腺炎的临床疗效。方法 选取2019年6月—2021年6月天津市第三中心医院收治的102例肉芽肿性小叶乳腺炎患者，按随机数字表法将所有患者分为对照组和治疗组，每组各51例。对照组口服甲泼尼龙片，起始剂量20 mg/d，每2周减量4 mg/d，直至以4 mg/d维持治疗。治疗组在对照组基础上口服消乳散结胶囊，3粒/次，3次/d。两组疗程均为3个月。观察两组的疗效，比较治疗前后两组乳腺疼痛视觉模拟量表（VAS）评分、病灶大小、36项健康调查简表（SF-36）评分及外周血T淋巴细胞亚群水平和血清白细胞介素-2（IL-2）、白细胞介素-6（IL-6）水平。结果 治疗后，治疗组总有效率为94.1%，显著高于对照组的80.4%（P＜0.05）。治疗后两组乳腺疼痛VAS评分均显著降低，乳腺肿块大小、肿块最长径均显著缩小（P＜0.05）；且均以治疗组的改善更显著（P＜0.05）。治疗后，两组SF-36中PCS、MCS评分及量表总分均较治疗前显著增加（P＜0.05）；且治疗后，治疗组SF-36中PCS、MCS评分及量表总分均显著高于对照组（P＜0.05）。治疗后，两组外周血CD4⁺ T细胞百分比、CD4⁺/CD8⁺值、IL-2、IL-6水平均显著减少，外周血CD8⁺ T细胞百分比均显著增加（P＜0.05）；且均以治疗组的改善更显著（P＜0.05）。结论 乳散结胶囊联合甲泼尼龙治疗肉芽肿性小叶乳腺炎可获得良好疗效，能有效缓解患者乳腺肿块和疼痛症状，缩小病灶范围，提高生活质量，并可进一步调节机体细胞免疫功能、减轻炎症反应，且安全性较好，值得临床推广应用。

Objective To observe the clinical effect of Xiaoru Sanjie Capsules combined with methylprednisolone in treatment of granulomatous lobular mastitis. Methods A total of 102 patients with granulomatous lobular mastitis admitted to Tianjin Third Central Hospital from June 2019 to June 2021 were selected and divided into control group and treatment group according to random number table method, with 51 cases in each group. Patients in the control group were po administered with Methylprednisolone Tablets, the initial dosage was 20 mg/d and decreased by 4 mg/d every 2 weeks until the treatment was maintained at 4 mg/d. Patients in the treatment group were po administered with Xiaoru Sanjie Capsules, 3 grains/time, 3 times daily. The treatment course of both groups was 3 months. The therapeutic effects of the two groups were observed, and the visual analog Scale (VAS) score, lesion size, SF-36 score, peripheral blood T lymphocyte subsets and serum interleukin-2 (IL-2) and interleukin-6 (IL-6) levels of the two groups were compared before and after treatment. Results After treatment, the total effective rate of the treatment group was 94.1%, significantly higher than that of the control group (80.4%) (P < 0.05). After treatment, the VAS score of breast pain was significantly decreased in both groups, and the size and longest diameter of breast mass were significantly reduced (P < 0.05). The improvement was more significant in the treatment group (P < 0.05). After treatment, PCS, MCS score, and total score of scale in SF-36 in 2 groups were significantly increased compared with before treatment (P < 0.05); After treatment, PCS, MCS score, and total score of scale in SF-36 in treatment group were significantly higher than those in control group (P < 0.05). After treatment, the percentage of CD4⁺ T cells, the ratio of CD4⁺/CD8⁺, the levels of IL-2 and IL-6 in peripheral blood were significantly decreased, while the percentage of CD8⁺ T cells in peripheral blood was significantly increased in both groups (P < 0.05). The improvement was more significant in the treatment group (P < 0.05). Conclusion Xiaoru Sanjie Capsules combined with methylprednisolone has good curative effect in treatment of granulomatous lobular mastitis, and can effectively relieve the breast mass and pain symptoms, narrow the scope of the focus, improve the quality of life, and can further regulate the cellular immune function of the body, reduce inflammatory response with good safety, which is worthy of clinical application.

R984

天津市自然科学基金项目（20JCQNJC61250）