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临床试验/NCT06227559
NCT06227559尚未招募不适用

The Role of Some Hematological Parameters in Juvenile Systemic Lupus Erythematosus

Assiut University0 个研究点目标入组 60 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Measure the absolute neutrophil-to-absolute lymphocyte ratio (NLR).

研究概览

简要总结

Juvenile systemic lupus erythematosus is an autoimmune disorder with multisystem involvement, leading to inflammatory damage to the joints, kidney, central nervous system, and hematopoietic system. Although the prevalence rate of juvenile systemic lupus erythematosus in a developing country is not known, as per literature the female-to-male ratio rises from 4.5 : 1 in adolescence to 8--12 : 1 in adult-onset patients.

  • The full mechanism of SLE is still unknown however, production of autoantibodies and immune complex deposition with subsequent infiltration of neutrophils, hyper-activation of B and T cells, reduced ability of immune complexes and apoptotic cell clearance, and defects in multiple immune regulatory networks, are central to organ inflammation and subsequent damage in SLE. Systemic lupus erythematosus goes on with organ involvements by remission and relapses.

详细描述

Juvenile systemic lupus erythematosus is an autoimmune disorder with multisystem involvement, leading to inflammatory damage to the joints, kidney, central nervous system, and hematopoietic system. Although the prevalence rate of juvenile systemic lupus erythematosus in a developing country is not known, as per literature the female-to-male ratio rises from 4.5 : 1 in adolescence to 8--12 : 1 in adult-onset patients.

  • The full mechanism of SLE is still unknown however, production of autoantibodies and immune complex deposition with subsequent infiltration of neutrophils, hyper-activation of B and T cells, reduced ability of immune complexes and apoptotic cell clearance, and defects in multiple immune regulatory networks, are central to organ inflammation and subsequent damage in SLE. Systemic lupus erythematosus goes on with organ involvements by remission and relapses.

The patients with SLE may present with various systemic manifestations. The general symptoms include: fever, malaise, arthralgias, myalgias, headache, and loss of appetite and weight. Nonspecific fatigue, fever, arthralgia, and weight changes.

  • JSLE prognosis is related to the affected organs/systems and is worse for children and adolescents compared to adults, perhaps due to the higher rate of renal and neurological involvement attributed to JSLE.

Over the last decades, the improvement of patient survival was mainly due to an early diagnosis and better therapeutic approach, especially regarding the severe manifestations of the disease. These included the introduction of hemodialysis, renal transplantation and use of immunosuppressive drugs and their complications, i.e., use of potent antibiotic and hypertensive drugs .

研究设计

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

入排标准

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

入选标准

  • Age at enrollment ≤18 years old.
  • The Patients should be diagnosed as jSLE, according to 2019 European league against rheumatism (EULAR)/ American college of rheumatology (ACR) SLE classification criteria, or the previous ACR 1997 SLE classification criteria.
  • Exclusion criteria:
  • Patients with autoimmune diseases other than j SLE
  • Patients not fulfilling the criteria for diagnosis of SLE
  • Active infections.
  • Malignancies.
  • Lymphoproliferative disorders.
  • Hematologic diseases
  • Hepatosplenic diseases and diabetic nephropathy

排除标准

  • 未提供

结局指标

主要结局

Measure the absolute neutrophil-to-absolute lymphocyte ratio (NLR).

时间窗: Baseline

Measuring the absolute neutrophil-to-absolute lymphocyte ratio (NLR) by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )

Measure the mean platelet volume (MPV).

时间窗: Baseline

Measuring the mean platelet volume (MPV) by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )

Measure the platelet count-to-absolute lymphocytes ratio (PLR).

时间窗: Baseline

Measuring the platelet count-to-absolute lymphocytes ratio (PLR) by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )

Measuring the monocyte distribution width (MDW)}.

时间窗: Baseline

Measuring the monocyte distribution width (MDW)} by automated complete blood count ( 2 ml of venous blood will be obtained from the 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

Hadeer Ali Mohamed Soliman Abdullah

Principal Investigator

Assiut University

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