Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis

Официальное название

Analysis of the Clinical Characteristics and Three Treatment Methods of Granulomatous Lobular Mastitis

Обзор

Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. This study aims to analyze the clinical characteristics and demographic data of GLM patients and to compare the overall effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy, with the goal of providing new insights for clinical treatment.

Подробное описание

In recent years, the incidence of this disease has been increasing annually. The incidence of GLM is region-specific, being higher in Mediterranean regions and Asian countries. The etiology is currently unclear, but many studies suggest that GLM is associated with autoimmune disorders, hormonal imbalances, and microbial infections . GLM has a long course, is difficult to treat, and prone to recurrence, causing significant trauma to the patient's breast appearance and overall well-being. Currently, the main treatment methods for GLM include surgical treatment, drug therapy, combined surgery with drug therapy, and close observation. Surgical treatment options mainly include abscess incision and drainage, segmental resection, subcutaneous mastectomy, mastectomy, and breast reconstruction. Although surgical treatment can rapidly improve the condition, the recurrence rate reported in the literature ranges from 5% to 50% . Although GLM is a benign disease, it can severely impact the patient's normal life, causing physical and psychological trauma. However, few studies have included patients' subjective treatment experiences in the evaluation of treatment outcomes.

To date, there have been no studies comparing the efficacy of three treatment methods (surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy) in the same population of GLM patients. This study aims to compare the efficacy and patient satisfaction of these three treatment methods, with the hope of providing new insights for clinical treatment options.

Вмешательства

• Процедура Surgery
  patients underwent complete excision of the inflammatory breast tissue and some surrounding normal tissue under combined intravenous with inhalation anesthesia. Damaged skin was also removed.
• Препарат triple anti-tuberculosis drug
  Patients took oral rifampin (450 mg/day), isoniazid (300 mg/day), and ethambutol (15 mg/kg/day).

Первичные конечные точки

• Differences in the cure rate of the three treatment modalities [Срок оценки: Baseline]
• Differences in the recurrence rate of the three treatment modalities [Срок оценки: Baseline]
• Differences in the incidence of adverse reactions of the three treatment modalities [Срок оценки: Baseline]

Вторичные конечные точки (2)

• Differences in the patient satisfaction score (points) of the three treatment modalities [Срок оценки: Baseline]
• Differences in the treatment duration (months) of the three treatment modalities [Срок оценки: Baseline]

Критерии участия

Критерии включения

• non-lactating and aged 15-65 years
• histopathological confirmation of GLM
• normal liver and kidney function

Критерии исключения

• lactating and pregnant women
• allergies to rifampin, isoniazid, or ethambutol
• concurrent malignant breast tumors
• severe underlying diseases
• other conditions deemed unsuitable by the investigator and
• refusal to participate in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• First affiliated hospital of Harbin medical university — Харбин

Публикации

• Kessler E, Wolloch Y. Granulomatous mastitis: a lesion clinically simulating carcinoma. Am J Clin Pathol. 1972 Dec;58(6):642-6. doi: 10.1093/ajcp/58.6.642. No abstract available. PMID 4674439
• Yuan QQ, Xiao SY, Farouk O, Du YT, Sheybani F, Tan QT, Akbulut S, Cetin K, Alikhassi A, Yaghan RJ, Durur-Subasi I, Altintoprak F, Eom TI, Alper F, Hasbahceci M, Martinez-Ramos D, Oztekin PS, Kwong A, Pluguez-Turull CW, Brownson KE, Chandanwale S, Habibi M, Lan LY, Zhou R, Zeng XT, Bai J, Bai JW, Chen QR, Chen X, Zha XM, Dai WJ, Dai ZJ, Feng QY, Gao QJ, Gao RF, Han BS, Hou JX, Hou W, Liao HY, Luo H PMID 35999646
• Akcan A, Akyildiz H, Deneme MA, Akgun H, Aritas Y. Granulomatous lobular mastitis: a complex diagnostic and therapeutic problem. World J Surg. 2006 Aug;30(8):1403-9. doi: 10.1007/s00268-005-0476-0. PMID 16847715
• Shang B, Zhang T, Liu C, Lu J, Cui C, Feng J, Zhou Y. Analysis of three treatment methods for granulomatous lobular mastitis: a retrospective study in a single center. Front Oncol. 2025 Apr 30;15:1588836. doi: 10.3389/fonc.2025.1588836. eCollection 2025. PMID 40371221

Идентификаторы

NCT: NCT06565845 · 2024182

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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