This study will establish a registration research platform, a clinical research database and a biospecimen bank for the prevention and treatment of COPD with Chinese medicine. Based on the COPD registry database, a cohort of Chinese medicine for COPD prevention and treatment will be established.
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease with high prevalence, high mortality rate, high disability rate and heavy disease burden, seriously endangering people\'s health. The prevalence of COPD among people aged 40 and above in China is 13.7%, with nearly 100 million patients. The situation of high prevalence, high mortality, and high disability is not matched by the low awareness rate, low lung function test rate, and low treatment rate, which is a serious situation for prevention and control. 2021 edition of 'Global Initiative on Chronic Obstructive Lung Disease (GOLD)' puts forward the concept of pre-COPD, which indicates that the concept of prevention and treatment of COPD has begun to change to prevention and early intervention, and is also related to the concept of intermediate medicine. The concept of pre-COPD has been proposed in the 2021 edition of GOLD, indicating that the concept of prevention and treatment of COPD has begun to shift towards prevention and early intervention, which is also in line with the idea of 'treating the disease before it is diagnosed' in TCM. Chinese medicine has certain advantages in the prevention and treatment of COPD. Currently, there is a lack of TCM diagnostic and treatment protocols for the early stage of COPD, and TCM diagnostic and treatment protocols for the stable stage of COPD need to be optimised. Therefore, based on the Chinese COPD registry management system, this study took the pre-CPD population and stable stage patients as the research object, and used the standardised use of Chinese medicine diagnostic and treatment protocols as the exposure factor to carry out a multicentre prospective cohort study, with a follow-up of 2 years, using the morbidity rate, the rate of decline in lung function FEV1, etc., to evaluate the efficacy of Chinese medicine diagnostic and treatment protocols for pre-COPD, and using the rate of occurrence of acute exacerbation, The efficacy of TCM treatment protocols for patients with stable COPD was further evaluated using the incidence of acute exacerbation and quality of survival. This will provide high-quality evidence-based medical evidence for the prevention and treatment of COPD by TCM.
Study Type
OBSERVATIONAL
Enrollment
10,000
Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure was defined as taking the medication continuously for more than 3 months per year, or taking the medication intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group was divided into an exposed group (TCM protocols cohort) and a non-exposed group (non-TCM protocols cohort).
Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure was defined as taking the medication continuously for more than 3 months per year, or taking the medication intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group was divided into an exposed group (TCM protocols cohort) and a non-exposed group (non-TCM protocols cohort).
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Frequencies of acute exacerbations (AEs)
The frequencies of acute exacerbations (AEs) will be recorded.
Time frame: Frequency of acute exacerbations at months 3, 6, 9, 12, 15, 18, 21, and 24.
Incidence of COPD
The incidence of COPD will be recorded.
Time frame: 24 months after enrollment.
6 Six Minute Walk Distance (6MWD)
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Time frame: 6MWD at months 3, 6, 9, 12, 15, 18, 21, and 24.
Traditional Chinese medicine syndromes
The Traditional Chinese medicine syndromes will be recorded.
Time frame: The Traditional Chinese medicine syndromes at months 3, 6, 9, 12, 15, 18, 21, and 24.
Forced expiratory volume in one second (FEV1)
FEV1 will be applied to assess pulmonary function.
Time frame: Change from baseline FEV1 at months 6, 12, 18 and 24.
Forced vital capacity (FVC)
FVC will be applied to assess pulmonary function.
Time frame: Change from baseline FVC at months 6, 12, 18 and 24.
FVC as the percentage of the predicted value (FVC%)
FVC% will be applied to assess pulmonary function.
Time frame: Change from baseline FVC% at months 6, 12, 18 and 24.
Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)
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FEV1/FVC will be applied to assess pulmonary function.
Time frame: Change from baseline FEV1/FVC at months 6, 12, 18 and 24.
Diffusing capacity of the lungs for carbon monoxide (DLCO)
DLCO will be applied to assess pulmonary function.
Time frame: Change from baseline DLCO at months 6, 12, 18 and 24.
COPD Assessment Test (CAT)
CAT will be applied to assess quality of life.
Time frame: At months 6, 12, 18 and 24.