Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-65
SponsorFirst Affiliated Hospital of Harbin Medical University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Surgery

    Procedure/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.

  • triple anti-tuberculosis drug

    Drug

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

Treatment groups

350 Participants
are divided into 3 treatment groups
Group A: surgery group1 intervention
Group B: triple anti-tuberculosis drug therapy group1 intervention
Group C: combination therapy group2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline

Other outcomes

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