A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders (GLMwPD)

Wuhan University

Status: Invitation-only

Conditions: Psychiatric Disorder; Breast Diseases; Mastitis Granulomatous

Treatments: Drug: conservative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05395949

GLMwPD

Details and patient eligibility

About

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 .

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Steroid combined with methotrexate

Experimental group

Description:

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.

Treatment:

Drug: conservative treatment

Extensive lesion excision

No Intervention group

Description:

Patients in the control group underwent wide local excision, make sure the margin is negative. Irrigation and mammoplasty were performed in the same way as in the observation group.