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临床试验/NCT03163147
NCT03163147Unknown不适用

The Effect and Frequency of Helicobacter Pylori Infection in Primary Immune Thrombocytopenic Patients Not Respond on Steroid Therapy.

Assiut University0 个研究点目标入组 100 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Percentage of primary thrombocytopenic patients with helicobacter pylori infection who recieved its treatment and improved clinically and laboratory.

研究概览

简要总结

Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count (i.e less than 100.000) . In ITP, platelet surface membrane proteins become antigenic for unknown reasons , leading to stimulation of the immune system , autoantibody production, and platelet destruction In recent years ,the list of etiologies of ITP has been steadily increasing, so the term "idiopathic" is becoming obsolete, increasingly replaced by "immune"TP .

Treatment of ITP may be conceptually divided into rescue therapy and maintenance therapy . the terminology of corticosteroid-dependence means The need for ongoing or repeated doses administration of corticosteroids for at least 2 months to maintain a platelet count at or above 30 _ 109/L and/or to avoid bleeding. So, patients with corticosteroid dependence are considered non responders

详细描述

• Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count (i.e less than 100.000) . In ITP, platelet surface membrane proteins become antigenic for unknown reasons , leading to stimulation of the immune system , autoantibody production, and platelet destruction In recent years ,the list of etiologies of ITP has been steadily increasing, so the term "idiopathic" is becoming obsolete, increasingly replaced by "immune"TP.

Treatment of ITP may be conceptually divided into rescue therapy and maintenance therapy. the terminology of corticosteroid-dependence means The need for ongoing or repeated doses administration of corticosteroids for at least 2 months to maintain a platelet count at or above 30 _ 109/L and/or to avoid bleeding. So, patients with corticosteroid dependence are considered non responders The recent entry of Helicobacter pylori to the growing list of etiologies of itp has stirred much interest. . The relationship between H pylori infection and immune thrombocytopenia (ITP) is less clear .

However, among patients with H.pylori-associated ITP, a significant percentage achieve lasting remission after eradication of H.pylori .

H.pylori can be readily detected by non invasive methods, the C-urea breath test and antigen detection in stools are considered to be the most accurate, with both sensitivity and specificity in the range of 90% to 95% .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 1.Patients diagnosed ITP and failed on steroid therapy.

排除标准

  • Patients with systemic lupus erythromatous
  • Drug administration
  • Hepatitis c infection

结局指标

主要结局

Percentage of primary thrombocytopenic patients with helicobacter pylori infection who recieved its treatment and improved clinically and laboratory.

时间窗: one year

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

Reham Badr

Assiut University

Assiut University

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