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临床试验/NCT01685099
NCT01685099Unknown不适用

Evaluating the Diagnostic Validity of Inflammation-associated Markers for Tuberculous Pleurisy

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
diagnosis of tuberculous pleurisy

研究概览

简要总结

  1. To investigate the difference of PE inflammation/apoptosis-associated markers between TB pleurisy and non-TB pleurisy
  2. To investigate the difference of neutrophil apoptosis in exudative PE between TB pleurisy and non-TB pleurisy
  3. To investigate the change of apoptosis pattern of PE neutrophil, before and after TB antigen stimulation, and compare the difference between TB pleurisy and non-TB pleurisy
  4. To investigate diagnostic aid of the inflammation/apoptosis-associated markers and apoptosis pattern of PE neutrophil for tuberculous pleurisy

详细描述

Tuberculosis (TB) remains a global health problem even though it has nearly been eradicated in some developed countries. Because of variable manifestations and the difficulty in collecting clinical samples, extra-pulmonary TB is usually difficult to early diagnose. Tuberculous pleurisy (TP) is one of the most common extra-pulmonary infection and accounts for approximately 5% of all forms of TB. The gold standard for diagnosing TP is mycobacterial culture of pleural effusion (PE), pleura tissue, which requires weeks to yield. The treatment could thus be delayed, resulting in an increased mortality rate. In addition, mycobacterial culture is not so sensitive for PE and with positivity in less than two thirds of cases with TB pleurisy.

For diagnosing TP, PE biomarkers are required to be investigated in addition to traditional PE cell counting and biochemistry. In particularly, inflammation-associated cytokines and apoptosis-associated markers may be important because the two pathways involve in TB infection/defense mechanism. For inflammation-association markers, current literature is not comprehensive except IFN-gamma and IFN-gamma release assay (IGRA). However, the result of IGRA using PE is disappointed. We should study other PE inflammation markers such as IFN-induced protein-10, interleukin [IL]-2, IL-12 and so on. On the other hand, apoptosis suppression is one of escape mechanisms in TB pathogenesis. Macrophage, dendritic cell, and neutrophil are reportedly inhibited for apoptosis in TB infection. But the apoptosis of PE neutrophil are rarely studied. Moreover, the role of apoptosis-associated markers (Fas ligand [FasL], decoy receptor 3, lipoxin, prostaglandin E2, caspases) in PE has rarely been investigated in diagnosing TP except FasL. Therefore, we conduct a prospective study to investigate inflammation/apoptosis-associated markers in exudative PE and apoptosis of PE neutrophil to analyze their diagnostic usefulness for TP.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient older than 20 years old
  • patients with exudative pleural effusion

排除标准

  • refusal of enrollment

结局指标

主要结局

diagnosis of tuberculous pleurisy

时间窗: 2 years

次要结局

  • mortality(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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