目的 觀察消乳散結(jié)膠囊聯(lián)合甲潑尼龍治療肉芽腫性小葉乳腺炎的臨床療效。方法 選取2019年6月—2021年6月天津市第三中心醫(yī)院收治的102例肉芽腫性小葉乳腺炎患者，按隨機數(shù)字表法將所有患者分為對照組和治療組，每組各51例。對照組口服甲潑尼龍片，起始劑量20 mg/d，每2周減量4 mg/d，直至以4 mg/d維持治療。治療組在對照組基礎(chǔ)上口服消乳散結(jié)膠囊，3粒/次，3次/d。兩組療程均為3個月。觀察兩組的療效，比較治療前后兩組乳腺疼痛視覺模擬量表（VAS）評分、病灶大小、36項健康調(diào)查簡表（SF-36）評分及外周血T淋巴細胞亞群水平和血清白細胞介素-2（IL-2）、白細胞介素-6（IL-6）水平。結(jié)果 治療后，治療組總有效率為94.1%，顯著高于對照組的80.4%（P＜0.05）。治療后兩組乳腺疼痛VAS評分均顯著降低，乳腺腫塊大小、腫塊最長徑均顯著縮?。?i>P＜0.05）；且均以治療組的改善更顯著（P＜0.05）。治療后，兩組SF-36中PCS、MCS評分及量表總分均較治療前顯著增加（P＜0.05）；且治療后，治療組SF-36中PCS、MCS評分及量表總分均顯著高于對照組（P＜0.05）。治療后，兩組外周血CD4⁺ T細胞百分比、CD4⁺/CD8⁺值、IL-2、IL-6水平均顯著減少，外周血CD8⁺ T細胞百分比均顯著增加（P＜0.05）；且均以治療組的改善更顯著（P＜0.05）。結(jié)論 乳散結(jié)膠囊聯(lián)合甲潑尼龍治療肉芽腫性小葉乳腺炎可獲得良好療效，能有效緩解患者乳腺腫塊和疼痛癥狀，縮小病灶范圍，提高生活質(zhì)量，并可進一步調(diào)節(jié)機體細胞免疫功能、減輕炎癥反應(yīng)，且安全性較好，值得臨床推廣應(yīng)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

天津市自然科學(xué)基金項目（20JCQNJC61250）