This study, based on past registration records, evaluates the clinical efficacy of traditional Chinese medicine in treating IPF in the real world, identifies advantageous populations and clinical targets, and provides references for precision traditional Chinese medicine treatment.
This study is based on a previously established registry of interstitial lung disease, with traditional Chinese medicine treatment as the exposure factor. A total of at least 1000 IPF patients will be continuously enrolled and followed up for 2 years; it will further observe the pattern of syndromes, disease characteristics, and their interrelationships during disease development, and evaluate the clinical efficacy of traditional Chinese medicine in treating IPF using indicators such as annual acute exacerbation rate and clinical symptoms. Based on the differences in efficacy indicators, it will identify the advantageous population, clarify the clinical efficacy advantage targets, and provide a basis for precision treatment with traditional Chinese medicine.
Study Type
OBSERVATIONAL
Enrollment
1,000
Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure is defined as taking the medication continuously for more than 3 months per year, or intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group is divided into an exposed group (TCM cohort) and an unexposed group (non-TCM cohort).
All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Annual acute exacerbation rate
The annual acute exacerbation rate will be calculated in each group at the end of the trial.
Time frame: Up to week 104
Progression-Free Survival(PFS）
According to "Idiopathic Pulmonary Fibrosis in Adults (Update) and Progressive Pulmonary Fibrosis: An Official Clinical Practice Guideline of the ATS/ERS/JRS/ALAT ": The time from enrollment to the first meeting of disease progression (at least two of respiratory symptoms, physiological evidence and radiological evidence).
Time frame: Evaluate the PFS at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
All-cause mortality rate
The all-cause mortality rate will be calculated in each group at the end of the trial.
Time frame: Up to week 104.
Lung transplantation rate
The lung transplantation will be calculated in each cohort at the end of the trial.
Time frame: Up to week 104.
The Traditional Chinese Medicine(TCM) Syndromes
Evaluating TCM syndromes by collecting patients' symptoms, signs, tongue and pulse information.
Time frame: Evaluate the TCM s]yndromes at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
Clinical symptoms and Signs
Clinical symptoms and Signs will be evaluated through a scale. The scale includes coughing, expectoration, chest tightness, shortness of breath, wheezin. The Clinical Symptom Rating Scale includes 6 items: cough, expectoration, chest tightness, shortness of breath, wheezing, and cyanosis. Each item has a score of 0-3, totaling 18 points. The higher the score, the worse he patient's condition.
jiansheng li, Professor
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Time frame: Evaluate the clinical symptoms and signs up at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
Forced vital capacity (FVC)
FVC will be applied to assess pulmonary function.
Time frame: Evaluate the FVC at baseline and at weeks 26, 52, 78 and 104.
FVC as the percentage of the predicted value (FVC%)
FVC% will be applied to assess pulmonary function.
Time frame: Evaluate the FVC% at baseline and at weeks 26, 52, 78 and 104.
Diffusing capacity of the lungs for carbon monoxide (DLCO)
DLCO will be applied to assess pulmonary function.
Time frame: Evaluate the DLCO at baseline and at weeks 26, 52, 78 and 104.
DLCO as the percentage of the predicted value (DLCO%)
DLCO% will be applied to assess pulmonary function.
Time frame: Evaluate the DLCO% at baseline and at weeks 26, 52, 78 and 104.
6 Six Minute Walk Distance(6MWD)
The 6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Time frame: Evaluate the 6MWD at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
The 30 - second sit - to - stand test(30s STS)
The 30 second sitting and standing test will be used to evaluate lower limb strenath and cardiopulmonary function.
Time frame: Evaluate the 30s STS at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
A Tool to Assess Quality of life (ATAQ-IPF) total scores
ATAQ-IPF is currently a specialized scale for evaluating the quality of life, consisting of 13 dimensions and 74 items, with each item scoring 1-5 points. The higher the score, the worse the quality of life.
Time frame: Evaluate the ATAQ-IPF total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
St. George's respiratory questionnaire (SGRQ) total scores
SGRQ is a scale used to evaluate the quality of life of patients, which includes three dimensions: symptoms, mobility, and the impact of disease on daily life, with a total of 50 items. The total score range of SGRQ is usually between 0 and 100, with higher scores leading to poorer quality of life.
Time frame: Evaluate the SGRQ total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
Dyspnea
Dyspnea will be assessed by 22.modified Medical Research Council(mMRC) scores. A score of 0-4 will be given according to the degree of immediate dyspnea. A higher score indicates a worse condition.
Time frame: Evaluate the mMRC total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
C-reactive protein (CRP)
The CRP level will be detected by ELISA technology.
Time frame: Evaluate the CRP level at baseline and at weeks 26, 52, 78 and 104.
Krebs Von den Lungen-6(KL-6)
The KL-6 level will be detected by ELISA technology.
Time frame: Evaluate the KL-6 level at baseline and at weeks 26, 52, 78 and 104.
The pulmonary artery systolic pressure (PASP)
The PASP will be measured byechocardiogram.
Time frame: Evaluate the PASP at baseline and at weeks 26, 52, 78 and 104.
The diameter of the pulmonary artery
The diameter of the pulmonary artery will be measured byechocardiogram.
Time frame: Evaluate the diameter of the pulmonary artery at baseline and at weeks 26, 52, 78 and 104.