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[病变切除加全乳探查冲洗加微小整形手术治疗肉芽肿性小叶性乳腺炎:一项随机对照研究]

[Lesion removal plus whole breast exploration and washing plus micro-plastic procedures in the treatment of granulomatous lobular mastitis: a randomized controlled study].

作者信息

Zhou R, Wu G S, He Y K, Hou J X, Lan L Y, Feng Q Y, Zheng L W, Yuan Q Q, Liao Y Q

机构信息

Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University, Wuhan 430071, China.

出版信息

Zhonghua Wai Ke Za Zhi. 2021 Nov 1;59(11):923-928. doi: 10.3760/cma.j.cn112139-20201207-00845.

DOI:10.3760/cma.j.cn112139-20201207-00845
PMID:34743455
Abstract

To examine the effect of"lesion removal plus whole breast exploration and washing plus micro-plastic surgery"in granulomatous lobular mastitis. 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 plus micro-plastic surgery"(observation group). Forty-five cases underwent"empirical breast lesion resection plus fascia tissue flap plasty plus 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 test, Wilcoxon rank-sum test, χ² test and Fisher exact test were used for comparison between groups. All procedures were completed successful, with no 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) 6.7%(3/45), 1), drainage time ((8.6±0.6) days (8.4±0.8) days, 1.921, 0.053) and hospital stay ((7.7±0.6) days (7.6±0.5) days, 1.633, 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) 24.4%(11/45), χ²=8.819, 0.003). The observation group had better cosmetic effects (-2.657, 0.008) and patient satisfaction than control group (-5.730, 0.000). The "lesion removal plus whole breast exploration and flushing plus micro-plastic surgery" has a good therapeutic effect and cosmetic value for patients with refractory granulomatous lobular mastitis.

摘要

探讨“病灶切除+全乳探查冲洗+乳房整形术”治疗肉芽肿性小叶性乳腺炎的效果。采用单中心前瞻性随机对照研究方法,选取2017年3月至2019年9月在武汉大学中南医院甲状腺乳腺外科拟行手术治疗的肉芽肿性小叶性乳腺炎患者。样本量通过优效性检验确定。根据文献及前期工作,两组各需97例。52例患者接受“病灶切除+全乳探查冲洗+乳房整形术”(观察组)。45例患者接受“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,次要研究终点包括手术并发症、切口愈合时间及术后患者满意度。采用独立样本t检验、Wilcoxon秩和检验、χ²检验及Fisher确切概率法进行组间比较。所有手术均顺利完成,无严重并发症。所有患者均随访(15.2±1.9)个月(范围:12至24个月)。两组术后并发症发生率(7.7%(4/52)对6.7%(3/45),P=1)、引流时间((8.6±0.6)天对(8.4±0.8)天,t=1.921,P=0.053)及住院时间((7.7±0.6)天对(7.6±0.5)天,t=1.633,P=0.102)差异均无统计学意义。观察组复发率显著低于对照组(3.8%(2/52)对24.4%(11/45),χ²=8.819,P=0.003)。观察组美容效果(Z=-2.657,P=0.008)及患者满意度均优于对照组(Z=-5.730,P=0.000)。“病灶切除+全乳探查冲洗+乳房整形术”对难治性肉芽肿性小叶性乳腺炎患者具有良好的治疗效果及美容价值。

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