Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis
- Conditions
- Granulomatous Mastitis
- Interventions
- Procedure: SurgeryDrug: triple anti-tuberculosis drug
- Registration Number
- NCT06565845
- Lead Sponsor
- First Affiliated Hospital of Harbin Medical University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 350
- non-lactating and aged 15-65 years
- histopathological confirmation of GLM
- normal liver and kidney function
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description surgery group Surgery The patients underwent surgery triple anti-tuberculosis drug therapy group triple anti-tuberculosis drug The patients were treated with triple anti-tuberculosis drugs combination therapy group Surgery The patients were treated with surgery first, and then took triple anti-tuberculosis drugs after surgery combination therapy group triple anti-tuberculosis drug The patients were treated with surgery first, and then took triple anti-tuberculosis drugs after surgery
- Primary Outcome Measures
Name Time Method Differences in the cure rate of the three treatment modalities Baseline 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 Baseline 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 Baseline 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 Outcome Measures
Name Time Method Differences in the treatment duration (months) of the three treatment modalities Baseline 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.
Differences in the patient satisfaction score (points) of the three treatment modalities Baseline 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.
Trial Locations
- Locations (1)
First affiliated hospital of Harbin medical university
🇨🇳Harbin, Heilongjiang, China