chronic obstructive pulmonary disease
Conditions
Interventions
The phenotype of chronic bronchitis (Short-term) group:Injection of methylprednisolone 40mg*1-5d
The phenotype of chronic bronchitis (Long-term) group:Injection of methylprednisolone 40mg*1-5d
Oral methylprednisolone 40mg*6-14d
The phenotype of emphysema (Short-term) group:Injection of methylprednisolone 40mg*1-5d
The phenotype of emphysema (Long-term) group:Injection of methylprednisolone 40mg*1-5d
Sponsors
Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of Ji'nan University
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients with acute aggravated chronic obstructive pulmonary disease. 2. No gender limit, aged between 40 and 85 years. 3. Meet one of the two phenotypes. 4. Pulmonary function suggests that FEV1 /FVC < 70% after bronchodilator (400ug salbutamol inhaled for 20 minutes). 5. The pH of blood gas analysis was between 7.35 and 7.45 when admitted to hospital without oxygen inhalation. 6. The patient is able to communicate verbally or in writing, sign an informed consent form, and is capable of completing tests related to the trial.
Exclusion criteria
Exclusion criteria: 1. AECOPD has progressed to severe respiratory failure and/or pulmonary encephalopathy and/or heart failure, and even to critical conditions such as invasive mechanical ventilation or admission to ICU. 2. In addition to COPD, there are clinically significant lung diseases, such as life-threatening pulmonary embolism, pneumothorax, pleural effusion, pulmonary infection, significant bronchiectasis, active tuberculosis, non-tuberculous mycobacterium lung disease, chronic pulmonary heart disease decompensated stage, pneumoconiosis, sarcoidosis, severe pulmonary fibrosis, pulmonary resection, obesity-related hypoventilation syndrome, and primary ciliary dyskinesia. 3. Other serious diseases outside the lung: According to the judgment of the researchers, the participation in the study may put the patients at risk or affect the test results, including but not limited to the conditions complicated with serious left heart disease, myocardial infarction, arrhythmia, severe hypertension and diabetes, gastrointestinal bleeding, tumors, etc., which may affect the completion of the study. 4. Use systemic glucocorticoids one month before admission. 5. Patients with known hypersensitivity or intolerance to COPD stabilizers. 6. Patients with severe COPD whose survival time after disease assessment is less than 6 months. 7. Patients with immunodeficiency, including human immunodeficiency virus (HIV-1 or HIV-2), who test positive. 8. Patients who are also participating in other clinical studies. 9. Pregnant and lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure (in-hospital treatment failure and treatment failure within 30 days of discharge); | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of stay in hospital;Time to first acute exacerbation during post-discharge follow-up to half a year;Number of acute exacerbations during post-discharge follow-up to half a year;Time to first hospitalization for AECOPD during post-discharge follow-up to half a year;The change in FEV1 during follow-up to half a year;The changes in quality of life during the post-discharge follow-up to half a year;Glucocorticoid treatment duration ;The cumulative dose of glucocorticoids;Hospitalization and non-hospitalization costs during hospitalization and post-discharge follow-up to half a year; | — |
Countries
China
Contacts
Public ContactLiu Shengming
The First Affiliated Hospital of Ji'nan University (Guangzhou Overseas Chinese Hospital)
Outcome results
None listed