Risk Factors and Biomarkers for Post-tuberculosis Lung Damage in a Chinese Cohort: Protocol for a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- lung function
研究概览
简要总结
This prospective study aims to determine the incidence of Post-tuberculosis lung damage (PTLD), examine trends in the changes in lung function, and investigate the impact of smoking and other factors on respiratory symptoms, lung function, and chest CT findings, which will aid in the development of prognostic and therapeutic strategies for PTLD.
详细描述
Introduction
Post-tuberculosis lung damage (PTLD) refers to residual pulmonary impairment following the completion of tuberculosis (TB) treatment, characterized by persistent respiratory symptoms and abnormal pulmonary function. The risk factors and biomarkers for PTLD have been scarcely investigated. Additionally, it remains unclear whether and to what extent cigarette smoking affects PTLD in patients with TB.
Methods and analysis: This prospective observational study will enroll 400 adult male ever-smoker or never-smoker patients aged 25-60 years, with newly confirmed active TB between 2022 and 2024 from the Department of Respiratory and Critical Care Medicine at Peking University Third Hospital and the Tuberculosis Department at Beijing Geriatric Hospital. Baseline data (age, smoking history, and smoking pack-years), clinical symptoms, lung functions, and chest CT (computed tomography) findings will be prospectively collected. Respiratory questionnaires, lung function measurements, and chest CT examinations will be completed during follow-up visits at 6 months after the initiation of TB treatment, immediately at the completion of TB treatment, and at 1 year, 2 years, and 3 years after the completion of TB treatment. Peripheral blood samples will be obtained at baseline to measure inflammatory mediators and cytokines in serum. The collected data will be analyzed to determine the incidence of and factors/biomarkers for PTLD after TB treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 25-60 years newly diagnosed with active pulmonary TB.
排除标准
- •patients with positive sputum smear or TB culture results;
- •human immunodeficiency virus-positive patients;
- •patients infected with multidrug-resistant TB;
- •patients with malignant neoplasms (e.g., lung cancer) or severe cardiovascular and cerebrovascular diseases;
- •non-compliant patients who were unable to complete the lung function tests;
- •patients without lung parenchymal destruction (such as tuberculous pleurisy). -
结局指标
主要结局
lung function
时间窗: half a year, 1 year, 2 year, and 3-year follow-up
Forced expiratory volume (FEV1, l/min), and forced vital capacity (FVC,l/min) are the important parameters in lung function. FEV1/FVC, diffusing capacity for carbon monoxide (DLCO), and other indicators, will also be observed during follow-up.
次要结局
- Absorption of TB lesions on lung CT scans after TB treatment(half a year, 1 year, 2 year, and 3year follow-up)