跳至主要内容
临床试验/NCT04110184
NCT04110184Unknown不适用

Haematological Indices in Systemic Lupus Erythematosus and Their Association With Disease Activity

Assiut University0 个研究点目标入组 84 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
84
主要终点
hematological indices and their association with activity in systemic lupus erythematosis patients.

研究概览

简要总结

The aim of this study is to investigate the value of several hematological indices such as:

  • neutrophil-lymphocyte ratio.
  • platelet-lymphocyte ratio.
  • red blood cell distribution width.
  • mean platelet volume (MPV), RDW/platelet ratio.
  • neutrophil / C3 ratio.
  • All these as biomarkers of activity in systemic lupus erythematosis patients.

详细描述

Systemic lupus erythematosus (SLE) is a clinically common autoimmune disease characterized by abnormal immune response to autologous tissue, eventually resulting in systemic disorders and diverse clinical manifestations of the patients.

The pathogenesis of SLE remains unclear, but environmental triggers and genetic factors contribute to the destruction of immune tolerance systems, the production of immunological lymphocytes, antibodies, and inflammatory cytokines.

The clinical manifestations of SLE range from constitutional symptoms, such as fever, sweats, weight loss, joint pain and skin rashes (including the classic butter fly rash), to more serious features, including the involvement of the central nervous system and kidneys.

However, to make a clinical diagnosis of SLE, The SLICC criteria require either that a patient satisfy at least 4 of 17 criteria, including at least 1 of the 11 clinical criteria and one of the six immunologic criteria, or that the patient has biopsy-proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA) or anti-double-stranded DNA (dsDNA) antibodies. Patients with higher disease activity often present severer damage of tissues and organs.

SLE is characterized by high heterogeneity, a complex pathophysiology and various clinical manifestations; thus, no test alone is sufficiently sensitive or specific for diagnosis. Active and inactive SLE patients were evaluated according to SLE disease activity index (SLEDAI).There is significant interest in the identification of biomarkers that can predict SLE and quantify disease activity.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • SLE patients who fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria (Petri et al., 2012).
  • All patients > 18 years old.

排除标准

  • Patients with other autoimmune disease such as: Rheumatoid arthritis (RA), Mixed connective tissue disease (MTCD), Dermatomyositis (DM) and Systemic Sclerosis (SS).
  • Patients with malignant diseases.
  • Patients with coronary artery disease, cerebrovascular disease, renal and liver diseases.
  • Patients with evidence of any concomitant inflammatory disease. Acute infection or chronic inflammatory status.
  • Patients with hematological disease or history of blood transfusion in the previous 4 months.

结局指标

主要结局

hematological indices and their association with activity in systemic lupus erythematosis patients.

时间窗: baseline

investigate the value of several hematological indices and their association with activity in systemic lupus erythematosis patients.

次要结局

未报告次要终点

研究者

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

AA Mohamed

doctor

Assiut University

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