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This study evaluates the clinical response rate of local steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive local injection combined with topical steroids and the other half will receive topical steroids mono-therapy.
Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.Clinical presentation of IGM can be variable. Some findings may be confused with breast malignancy.
Although IGM as a disease has been known for nearly four decades, no treatment consensus has been reached because of its rarity. Surgical treatment, antibiotics, oral steroids, topical steroids, immunosuppression (methotrexate, mycophenolate mofetil) and close follow up have all been reported to be effective.
Currently,surgical treatment and systemic steroids treatment are most frequently employed. With the consideration of side effects of long term systemic (oral) steroid usage, topical steroids without systemic use were assessed and showed satisfactory curative effect. But there is no data concerning the use of local injection of steroids therapy on IGM.The purpose of this study is to evaluate the effectiveness of steroids local injection on the basis of topical steroids for IGM treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local injection | Experimental | Compound betamethasone injection (Each injection contains betamethasone dipropionate at 5 mg for betamethasone and betamethasone sodium phosphate at 2 mg for betamethasone) was local injected to the breast by the patient once a week for one to four times followed by Hydrocortisone butyrate cream(0.1%) topical use twice a day until the termination of treatment. |
|
| topical | Active Comparator | Hydrocortisone butyrate 0.1% cream was applied to the breast by the patient twice a day until the termination of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Betamethasone Injection | Drug | local injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| clinical response rate | The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| granulomatous mastitis recurrence | IGM relapses in the Ipsilateral breast. | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanna Zhang, M.D. | Contact | 86-10-69158703 | pumchzyn@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Sun, Master | Peking Union Medical College Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Breast Surgery,Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26920409 | Background | Tahmasebi S, Karami MY, Maalhagh M. Granulomatous Mastitis: Time to Introduce New Weapons. World J Surg. 2016 Nov;40(11):2827-2828. doi: 10.1007/s00268-016-3438-9. No abstract available. | |
| 26148520 | Background | Altintoprak F, Kivilcim T, Yalkin O, Uzunoglu Y, Kahyaoglu Z, Dilek ON. Topical Steroids Are Effective in the Treatment of Idiopathic Granulomatous Mastitis. World J Surg. 2015 Nov;39(11):2718-23. doi: 10.1007/s00268-015-3147-9. |
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| ID | Term |
|---|---|
| D058890 | Granulomatous Mastitis |
| ID | Term |
|---|---|
| D008413 | Mastitis |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C007975 | hydrocortisone-17-butyrate |
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| Hydrocortisone Butyrate 0.1% Cream |
| Drug |
topical use |
|
| 26829298 | Background | Sheybani F, Naderi HR, Gharib M, Sarvghad M, Mirfeizi Z. Idiopathic granulomatous mastitis: Long-discussed but yet-to-be-known. Autoimmunity. 2016 Jun;49(4):236-9. doi: 10.3109/08916934.2016.1138221. Epub 2016 Feb 1. |
| 27067146 | Background | Benson JR, Dumitru D. Idiopathic granulomatous mastitis: presentation, investigation and management. Future Oncol. 2016 Jun;12(11):1381-94. doi: 10.2217/fon-2015-0038. Epub 2016 Apr 12. |
| D000091642 | Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |