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临床试验/NCT06007040
NCT06007040已完成不适用

Interstitial Lung Disease Associated

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

This single-center, retrospective cohort study was conducted to determine whether ANCA-ILD spectrum share the same clinical manifestations and outcome with CTD feature disease spectrum.

详细描述

We retrospectively reviewed patients who had been diagnosed with interstitial pneumonia during outpatient or hospitalization at Peking Union Medical College Hospital (PUMCH) between January 2012 and December 2021.

  1. Baseline data collection:

  2. Baseline information at the time of initial diagnosis was obtained, and the following items were analyzed: demographic information (age, gender), clinical course, clinical symptoms and signs, laboratory findings [routine blood, erythrocyte sedimentation rate (ESR), hypersensitivity C-reactive protein (Hs-CRP), rheumatoid factor (RF) and serologic autoantibodies], pulmonary function tests (PFTs), and chest HRCT scans.

  3. MPO-ANCA and PR3-ANCA titers were measured by ELISA.

  4. Chest HRCT images were evaluated by at least two pulmonologists and radiologists. The HRCT scans were analyzed for the following characteristics: ground-glass opacities, reticular patterns, honeycombing, traction bronchiectasis.

  5. Spirometry was performed according to standardized guidelines. PFTs results were expressed as percentages of the predicted values, thereby correcting for age, gender and bodyweight.

  6. Treatment was defined as the use of corticosteroids ≥ 10mg/d, azathioprine, cyclophosphamide, mycophenolate mofetil, methotrexate, or rituximab. Follow-up was up to the time of patient's last visit or time of death, and the outcomes were defined as death from all causes.

  7. Outcome

研究设计

研究类型
Observational
观察模型
Cohort
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

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

排除标准

  • ILD induced by drug, environment, or occupational exposure
  • Hypersensitivity pneumonitis and sarcoidosis

结局指标

主要结局

All-cause mortality

时间窗: From baseline until the date of death from all cause, up to 5 years

death from all causes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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