About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
non-lactating and aged 15-65 years
histopathological confirmation of GLM
normal liver and kidney function
Disqualifiers
lactating and pregnant women
allergies to rifampin, isoniazid, or ethambutol
concurrent malignant breast tumors
severe underlying diseases
Trial population
Female patients with GLM who were treated at the Breast Surgery Department of the First Affiliated Hospital of Harbin Medical University were selected.Patients with GLM mostly present with unilateral disease, and the lesions can be located in any part of the breast. Arthritis and lower limb erythema nodosum are rare.
Trial design
Case-control
Retrospective
Treatments tested in this trial
Surgery
Procedure/Surgerypatients underwent complete excision of the inflammatory breast tissue and some surrounding normal tissue under combined intravenous with inhalation anesthesia. Damaged skin was also removed.
triple anti-tuberculosis drug
DrugPatients took oral rifampin (450 mg/day), isoniazid (300 mg/day), and ethambutol (15 mg/kg/day).
Treatment groups
Trial outcomes
Primary outcomes
Differences in the cure rate of the three treatment modalities
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The cure rate was compared among the three groups.
Differences in the recurrence rate of the three treatment modalities
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The recurrence rate was compared among the three groups.
Differences in the incidence of adverse reactions of the three treatment modalities
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The incidence of adverse reactions was compared among the three groups.
Secondary outcomes
Differences in the patient satisfaction score (points) of the three treatment modalities
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The patient satisfaction score (points) was compared among the three groups.
Differences in the treatment duration (months) of the three treatment modalities
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The treatment duration (months) was compared among the three groups.
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