RecruitingNCT06565845

Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis

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

Sponsor

First Affiliated Hospital of Harbin Medical University

Enrollment

350 participants

Start Date

Aug 19, 2024

Study Type

OBSERVATIONAL

Conditions

Granulomatous Mastitis

Summary

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.

Eligibility

Sex: FEMALEMin Age: 15 YearsMax Age: 65 Years

Inclusion Criteria3

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

Exclusion Criteria6

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

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Interventions

PROCEDURESurgery

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.

DRUGtriple anti-tuberculosis drug

Patients took oral rifampin (450 mg/day), isoniazid (300 mg/day), and ethambutol (15 mg/kg/day).