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临床试验/NCT04613219
NCT04613219Unknown不适用

Correlation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung Disease

Jing Liang1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年10月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
The level of a lymphocyte in a lymphocyte subset correlates with disease activity.

研究概览

简要总结

Acute respiratory distress syndrome (ARDS) occurs in Clinically Amyopathic Dermatomyisitis(CADM) combined with Rapidly Progressive Interstitial Lung Disease(RPILD) within 1-3 months, which leads to death of patients and is difficult to treat. Even if high doses of glucocorticoids are ineffective, there is no recommended treatment for such patients, which is a huge medical challenge.Lymphopenia is an independent risk factor for death in CADM-RPILD, but the cause of lymphopenia is unclear.In this study, the level of lymphocyte subsets in peripheral blood was detected by flow cytometer, in order to further clarify the pathogenesis of the disease, to facilitate clinical guidance of treatment, and to improve the survival rate of patients.In addition, studies have shown that INF-α levels are significantly increased in CADM patients combined with RPILD and are a poor prognostic factor for CADM-RPILD, suggesting that the interferon system plays a role in the pathogenesis of CADM and can be used as an evaluation index of the severity of CADM-RPILD.In this study, the levels of relevant cytokines including INF and IL-2, IL-17, IL-18, IL-6 were detected simultaneously, and the relationship between disease activity and lymphocyte subsets was analyzed, and the changes of lymphocyte subsets after Tofacitinib treatment were determined in order to facilitate clinical guidance of treatment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age≥18 years old,≤80years old,no gender limit;
  • CADM of diagnosis according to Sontheimer diagnostic criteria;
  • combined with Rapidly Progressive Interstitial Lung Disease

排除标准

  • Age<18years old,>80years old;
  • potential malignant tumor

结局指标

主要结局

The level of a lymphocyte in a lymphocyte subset correlates with disease activity.

时间窗: 3 month

次要结局

未报告次要终点

研究者

发起方
Jing Liang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jing Liang

dean of orthopedic department

Qianfoshan Hospital

研究点 (1)

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