跳至主要内容
临床试验/NCT05395949
NCT05395949Enrolling By Invitation不适用

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

Wuhan University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
1
主要终点
Recurrence rate

研究概览

简要总结

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged 18 years or older with granulomatous lobular mastitis
  • Patients with Psychiatric Disorders;
  • Patients volunteered to participate in the study after informed consent.

排除标准

  • Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
  • Patients in acute exacerbation of mental illness

研究组 & 干预措施

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.

干预措施: conservative treatment (Drug)

结局指标

主要结局

Recurrence rate

时间窗: 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

时间窗: Up to 1 years

Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table.

次要结局

  • recovery time(Up to 2 years)

研究者

发起方
Wuhan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gaosong Wu, Ph D, MD

Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University

Wuhan University

研究点 (1)

Loading locations...

相似试验

A Randomized Controlled Study of Conservative... | 临床试验