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目的:探讨病灶清除+全乳探查冲洗+一期微整形治疗肉芽肿性小叶性乳腺炎的效果。方法:采用单中心前瞻性随机对照研究方法，于2017年3月至2019年9月入组在武汉大学中南医院甲状腺乳腺外科拟接受手术治疗的肉芽肿性小叶性乳腺炎患者资料。根据文献报道及前期工作基础，采用优效性检验计算样本量，共纳入97例患者。采用随机数字表法分组，52例患者行病灶清除+全乳探查冲洗+一期微整形（观察组），45例行经验性乳腺病灶切除术+筋膜组织瓣成形术+乳头乳晕矫正术（对照组）。主要研究终点为复发率，次要研究终点为手术并发症、切口愈合时间、术后患者满意度等。组间比较采用独立样本n t检验、Wilcoxon秩和检验、χ2检验、Fisher确切概率法等。n 结果:两组均完成手术，无严重并发症发生患者随访（15.2±1.9）个月（范围：12~24个月），两组术后并发症发生率［7.7%（4/52）比6.7%（3/45），n P=1］、引流时间［（8.6±0.6）d比（8.4±0.8）d，n t=1.921，n P=0.053］和住院时间［（7.7±0.6）d比（7.6±0.5）d，n t=1.633，n P=0.102］的差异均无统计学意义。观察组复发率低于对照组［3.8%（2/52）比24.4%（11/45），χ2=8.819，n P=0.003］，观察组美容效果（n Z=-2.657，n P=0.008）和患者满意度（n Z=-5.730，n P=0.000）优于对照组。n 结论:病灶清除+全乳探查冲洗+一期微整形对难治性肉芽肿性小叶性乳腺炎患者具有较好的治疗效果及美容价值。“,”Objective:To examine the effect of“lesion removal+whole breast exploration and washing+micro-plastic surgery”in granulomatous lobular mastitis.Methods:A single-center prospective randomized controlled study method was used to enroll patients diagnosed with granulomatous lobular mastitis for whom surgical procedures were projected from March 2017 to September 2019 at Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University. The sample size is determined by the superiority test. Based on the literatures and the previous work, the two groups require 97 cases. Fifty-two patients underwent“lesion removal+whole breast exploration and washing+micro-plastic surgery”(observation group). Forty-five cases underwent“empirical breast lesion resection+fascia tissue flap plasty+nipple and areola correction”(control group). The primary study endpoint is the recurrence rate, and the secondary study endpoints include surgical complications, incision healing time, and postoperative patient satisfaction. Independent sample n t test, Wilcoxon rank-sum test, χ2 test and Fisher exact testwere used for comparison between groups.n Results:All procedures were completed successful, with on severe complications. All patients were followed up for (15.2±1.9) months (range: 12 to 24 months). There were no significant differences in incidence of postoperative complications 7.7% (4/52) n vs. 6.7%(3/45), n P=1), drainage time ((8.6±0.6) days n vs. (8.4±0.8) days, n t=1.921, n P=0.053) and hospital stay ((7.7±0.6) daysn vs. (7.6±0.5) days, n t=1.633, n P=0.102) between the two groups. The recurrence rate of the observation group was lower significantly than that of the control group (3.8% (2/52) n vs. 24.4%(11/45), χ2=8.819, n P=0.003). The observation group had better cosmetic effects (n Z=-2.657, n P=0.008) and patient satisfaction than control group (n Z=-5.730, n P=0.000).n Conclusion:The“lesion removal+whole breast exploration and flushing+micro-plastic surgery”has a good therapeutic effect and cosmetic value for patients with refractory granulomatous lobular mastitis.