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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid combined with methotrexate | Experimental | 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. |
|
| Extensive lesion excision | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conservative treatment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | 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. | Up to 1 years |
| Breast appearance and cosmetic effect score | Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table. | Up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| recovery time | 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 | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaosong Wu | Wuhan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430071 | China |
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| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| D058890 | Granulomatous Mastitis |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008413 | Mastitis |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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