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临床试验/NCT04762810
NCT04762810Unknown4 期

A Prospective Study to Evaluate the Efficacy and Safety of Cyclophosphamide in the Treatment of Idiopathic Retroperitoneal Fibrosis

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
40
试验地点
1
主要终点
remission

研究概览

简要总结

This prospective, interventional, controlled study is aimed to evaluate the efficacy and safety of cyclophosphamide in the treatment of idiopathic retroperitoneal fibrosis, which refers to the chronic nonspecific inflammation of retroperitoneal fascia and adipose tissue that gradually evolves into fibroproliferative disease.

详细描述

Idiopathic retroperitoneal fibrosis is a chronic disease that requires treatment for a few years. Patients with this disease respond well to glucocorticoid therapy, so you need to take glucocorticoid medication once the diagnosis is established. In addition, most patients need to use immunosuppressants when taking glucocorticoids. At present, the most commonly used immunosuppressants in the world are cyclophosphamide, azathioprine, methotrexate and mycophoranate, etc. The function of the above drugs is to improve the disorder of the immune system function, in order to restore the normal immune state, so that the inflammation and swelling of the affected organs disappear, restore the normal function. It should be emphasized that if the use of hormones and immunosuppressant is not standard or stopped too early, it can lead to disease recurrence. Therefore, after the disease is under control, long-term adherence to medication is needed to maintain a stable state of the disease.

At present, there is no clear treatment guideline for idiopathic retroperitoneal fibrosis in the world, and the addition of immunosuppressant is also out of debate. Therefore, a comprehensive evaluation of its pathogenesis, clinical characteristics and treatment response is needed.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-75 diagnosed as IRPF. The diagnosis of idiopathic retroperitoneal fibrosis is based on the following aspects :(1) the swelling of retroperitoneal tissue , which seems neoplastic; (2) A large number of lymphocytes proliferated and infiltrated in the affected tissues and organs, and tissues showed inflammation, fibrosis and sclerosis, in which IgG4-positive cells accounted for less than 50% of plasma cells; (3) Increased inflammatory markers, such as ESR and CRP; (4) Good response to glucocorticoid therapy.

排除标准

  • malignancy retroperitoneal fibrosis secondary to other diseases or drugs or abdominal surgeries.

研究组 & 干预措施

Cyclophosphamide and Glucocorticoids

Experimental

Through the selective depletion of proliferating lymphocytes, cyclophosphamide has an inhibitory effect on both humoral and cellular immunity. Cyclophosphamide 50mg per day for 6 months and decrease to 50mg Qod for 6 months.

干预措施: Cyclophosphamide and glucocorticoids (Drug)

Glucocorticoids monotherapy

Active Comparator

Prednisone/prednisolone: started at 0.6-0. 8mg/kg.d for 2 to 4 weeks, tapered at 5mg per 1-2 weeks before 15mg per day, and tapered at 2.5-5mg per 2 weeks to equal to or less than 5mg per day in 6 months.

干预措施: Glucocorticoids (Drug)

结局指标

主要结局

remission

时间窗: 5 years

Patients achieve remission in symptoms and laboratory tets or radiologic images and have a low diseae activity after treatment.

次要结局

  • relapse(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen Zhang

Professor

Peking Union Medical College Hospital

研究点 (1)

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