Breast Diseases, Mastitis Granulomatous, Psychiatric Disorder
Conditions
Keywords
granulomatous lobular mastitis ；Psychiatric Disorder；Steroid
Brief summary
Granulomatous lobular mastitis (GLM) is a relatively rare chronic inflammatory disease of the breast in clinical practice. A small number of patients develop hyperprolactinemia during psychiatric drug treatment, and most of these patients are nulliparous. At present, there is no unified treatment mode at home and abroad, and surgery is generally the main treatment. GLM is a sterile inflammation, and glucocorticoids and methotrexate can effectively relieve clinical symptoms and even reach the standard of cure. In order to reduce the recurrence rate and protect the breast appearance as much as possible, we propose a conservative therapy. The purpose of this study was to compare this conservative therapy of granulomatous lobular mastitis with existing surgical treatment, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients with psychiatric disorders .
Interventions
DRUGconservative treatment
Prednisone 30 mg/day, supplemented with calcium and omeprazole, and Prednisone were slowly reduced to 10 mg/day after symptoms were relieved, and combined with 7.5 mg/week MTX therapy.
Sponsors
Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years or older with granulomatous lobular mastitis * Patients with Psychiatric Disorders; * Patients volunteered to participate in the study after informed consent.
Exclusion criteria
* Patients were diagnosed with mastitis with other definite etiology confirmed by pathology * Patients in acute exacerbation of mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | Up to 1 years | Inflammatory changes, mass, abscess or fistula formation, nodular erythema of the upper and lower extremities and joint pain occurred in the ipilateral breast within one year after surgery was defined as recurrence. |
| Breast appearance and cosmetic effect score | Up to 1 years | Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recovery time | Up to 2 years | the timing of the disappearance of the symptoms including Inflammatory changes, mass, abscess or fistula formation, nodular erythema of the upper and lower extremities and joint pain occurred in the ipilateral breast |
Countries
China
Outcome results
None listed