A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: conservative treatment.
- Who it may be relevant to
- Registry conditions: Breast Diseases, Mastitis Granulomatous, Psychiatric Disorder. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug conservative 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.
Primary outcome measures
- Recurrence rate [Time frame: Up to 1 years]
- Breast appearance and cosmetic effect score [Time frame: Up to 1 years]
Secondary outcome measures (1)
- recovery time [Time frame: Up to 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongnan Hospital of Wuhan University — Wuhan
Identifiers
NCT: NCT05395949 · GLMwPD