Observational Study of Clinical Features and Outcome of Interstitial Lung Disease With Anti-neutrophil Cytoplasmic Antibody in Chinese Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Death From All Causes
研究概览
简要总结
The purpose of this study is to investigate the clinical features and long-term outcome of anti-neutrophil cytoplasmic antibody (ANCA)-positive interstitial lung disease (ILD) and assess the difference between microscopic polyangiitis (MPA) associated ILD and isolated ANCA-positive idiopathic interstitial pneumonia.
详细描述
ILD patients with serum ANCA-positivity were enrolled in this study.
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Baseline data collection:
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Demographics information (age, gender)
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Clinical course
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Clinical symptoms and signs (cough, dyspnea, fever, fatigue, crackling, clubbing fingers, mechanics hand)
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Laboratory findings (blood and urine routine, liver and renal function tests, erythrocyte sedimentation rate, C reactive protein)
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Serologic tests (ANA , Rheumatoid factor , Anti-cyclic citrullinated peptide (CCP), Anti-dsDNA, Anti-Ro (SS-A), Anti-La (SS-B), Anti-Smith, Anti-Scl-70, Anti-Jo-1)
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Systemic manifestation if diagnosed as systemic vasculitis
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Pulmonary function tests (ventilation and diffusion capacity test)
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Chest high-resolution computed tomography (HRCT)
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Treatment: treatment will be given according to the experience of each pulmonologist.
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Follow-up:
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Patients were followed up at least once a year and basic laboratory tests, serologic autoantibodies, pulmonary function test and chest HRCT were evaluated routinely
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Follow-up end point was April 2019.
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Outcome
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Aged from 18 to 85 years with informed consent
- •Have a diagnosis of ILD based on clinical symptoms and radiologic features, with or without histopathologic results
- •Have available ANCA testing results during the first visit and follow-up period
排除标准
- •Connective tissue disease associated ILD
- •ILD induced by drug, environment, or occupational exposure
- •Hypersensitivity pneumonitis and sarcoidosis
结局指标
主要结局
Death From All Causes
时间窗: From baseline until the date of death from all cause, up to 5 years
Death from all causes Retrieved from medical records.
Number of Patients Who Underwent Lung Transplantation
时间窗: From baseline until the date of transplantation, up to 5 years
Number of patients who underwent lung transplantation Retrieved from medical records.
次要结局
未报告次要终点