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局部、全身和联合激素治疗特发性肉芽肿性乳腺炎的前瞻性随机研究。

Comparison of Topical, Systemic, and Combined Therapy with Steroids on Idiopathic Granulomatous Mastitis: A Prospective Randomized Study.

机构信息

Department of General Surgery, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.

Department of Radiology, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.

出版信息

World J Surg. 2019 Nov;43(11):2865-2873. doi: 10.1007/s00268-019-05084-x.

DOI:10.1007/s00268-019-05084-x
PMID:31297582
Abstract

BACKGROUND

Idiopathic granulomatous mastitis (IGM) is a benign disorder of the breast, for which the optimal treatment modality remains missing.

METHODS

A total of 124 patients with a histopathologically proven diagnosis of IGM were enrolled in a prospective, randomized parallel arm study. Patients were treated with topical steroids in Group T (n: 42), systemic steroids (0.8 mg/kg/day peroral) in Group S (n: 42), and combined steroids (0.4 mg/kg/day peroral + topical) in Group C (n: 40). Compliance with the therapy, response to the therapy, the duration of therapy, side effects and the recurrence rates were compared.

RESULTS

Sixteen patients did not comply with the treatment, and the highest ratio of compliance with therapy was seen in Group T (p < 0.05). Complete clinical regression (CCR) was observed in 90 (83.3%) patients. Response to the treatment (RT) was evaluated radiologically and observed in 89.8% of the patients. There was no statistically significant difference between groups regarding CCR, RT and the recurrence rate. The longest duration of therapy was observed in Group T (22 ± 9.1-week), whereas the shortest was observed in Group S (11.7 ± 5.5-week) (p < 0.001). The systemic side effects were significantly lower in Group T in comparison with Groups S and C (2.4% vs. 38.2% and 30.3%, respectively) (p < 0.001).

CONCLUSIONS

The efficiency of the treatment was similar for all groups, both clinically and radiologically. Although the duration of therapy was longer in Group T, the lack of systemic side effects increased the compliance of the patients with the therapy. Therefore, topical steroids would be among first-line treatment options of IGM.

摘要

背景

特发性肉芽肿性乳腺炎(IGM)是一种良性乳腺疾病,目前仍缺乏最佳的治疗方法。

方法

共有 124 名经组织病理学证实为 IGM 的患者参与了一项前瞻性、随机平行臂研究。患者分为三组,T 组(n:42)接受局部皮质类固醇治疗,S 组(n:42)接受全身皮质类固醇(0.8mg/kg/天口服)治疗,C 组(n:40)接受联合皮质类固醇(0.4mg/kg/天口服+局部)治疗。比较三组患者的治疗依从性、治疗反应、治疗持续时间、副作用和复发率。

结果

16 名患者未遵医嘱治疗,T 组的治疗依从性最高(p<0.05)。90 名(83.3%)患者出现完全临床缓解(CCR)。89.8%的患者影像学评估显示治疗反应(RT)。三组患者的 CCR、RT 和复发率无统计学差异。T 组的治疗持续时间最长(22±9.1 周),S 组最短(11.7±5.5 周)(p<0.001)。T 组的全身副作用明显低于 S 组和 C 组(2.4%比 38.2%和 30.3%)(p<0.001)。

结论

三组患者的治疗效果均相似,无论从临床还是影像学角度来看。虽然 T 组的治疗持续时间较长,但由于缺乏全身副作用,患者对治疗的依从性更高。因此,局部皮质类固醇可能是 IGM 的一线治疗选择之一。

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