Salehi Marzieh, Salehi Hassan, Moafi Mohammad, Taleban Roya, Tabatabaei Seyed Abass, Salehi Maryam, Salehi Mohammad-Mahdi
Department of Infectious Diseases, Isfahan University of Medical Sciences, Isfahan, Iran.
Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
J Res Med Sci. 2014 Mar;19(Suppl 1):S5-8.
Idiopathic granulomatous mastitis (IGM) is defined as a rare, inflammatory, chronic and benign disease mimicking malignant hyperplasia of mammary glands. There is no definitive therapeutic strategy for IGM; nevertheless, some approaches can be exploited as beneficial strategies. In this study, the surgery strategy was compared with coincident treatment with azithromycin and corticosteroid in IGM patients.
This study was implemented as clinical trial during 2011-2013 in Isfahan, Iran. The target population comprised women whose IGM was substantiated. The medical group consisted of 20 patients, which were compared with a historical control group treated through surgical approach. Surgical group comprised 39 patients. Partial mastectomy was implemented in the surgical group whereas treatment protocol comprising azithromycin and prednisolone administered in medical group. Recurrence of mass was followed for 12 months. Fischer exact test, Chi-square test, Mann-Whitney and regression tests were applied for statistical analysis. This study was registered in Iranian Registry of clinical trial (IRCT number: IRCT 2013123015999N1).
No significant differences were recognized in side of lesions, lymphadenopathy, fever and pain; however, number of abscesses, number of lesions and size of lesions were significantly higher in the surgical group (P < 0.0001). Furthermore, probability of relapse correlated with the number of lesions, (odds ratio = 24.67 confidence interval [CI] = 2.2-269.3), whereas methods of IGM treatment did not contribute to the likelihood of relapse (odds ratio = 12.5 CI = 0.52-299).
This clinical trial demonstrated that pharmaceutical treatment has appropriate efficacy, in treatment and prevention of IGM relapse. Moreover, this study presented hazf gardad number of the lesions as the most appropriate criteria for IGM prognosis, thus the probability of relapse decreases whether earlier IGM recognizing could be implemented.
特发性肉芽肿性乳腺炎（IGM）被定义为一种罕见的、炎症性的、慢性的良性疾病，类似于乳腺恶性增生。目前尚无针对IGM的确切治疗策略；然而，一些方法可被用作有益的策略。在本研究中，对IGM患者的手术策略与阿奇霉素和皮质类固醇联合治疗进行了比较。
本研究于2011 - 2013年在伊朗伊斯法罕进行临床试验。目标人群为IGM得到证实的女性。医疗组由20名患者组成，并与采用手术方法治疗的历史对照组进行比较。手术组包括39名患者。手术组实施了部分乳房切除术，而医疗组采用包括阿奇霉素和泼尼松龙的治疗方案。对肿块复发情况进行了12个月的随访。采用费舍尔精确检验、卡方检验、曼 - 惠特尼检验和回归检验进行统计分析。本研究已在伊朗临床试验注册中心注册（IRCT编号：IRCT 2013123015999N1）。
在病变部位、淋巴结病、发热和疼痛方面未发现显著差异；然而，手术组的脓肿数量、病变数量和病变大小显著更高（P < 0.0001）。此外，复发概率与病变数量相关（优势比 = 24.67，置信区间[CI] = 2.2 - 269.3），而IGM的治疗方法对复发可能性没有影响（优势比 = 12.5，CI = 0.52 - 299）。
该临床试验表明，药物治疗在治疗和预防IGM复发方面具有适当疗效。此外，本研究提出病变数量是IGM预后的最合适标准，因此，如果能更早地识别IGM，复发概率会降低。
