Acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
Conditions
Interventions
Experimental:Xuebijing injection 50ml in 100ml of Normal Saline IV, in 60mins, per 12 hours. administration of the agent for consecutive 5 days
Comparator:Normal Saline 150ml IV, in 60mins, per 12 hours. administration of the agent for consecutive 5 days
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of COPD: Forced Expiratory Volume in 1 second of less than 70% predicted value after bronchodilator; Acute exacerbation of COPD: the clinical presentation of the patient complaining of an acute change of symptomsthat is beyond normal day-to-day variation, and its need to adjust the medication (following Global initiative for Chronic Obstructive Lung DiseaseGOLD2016); 2. Hospitalizations indication: Duration of worsening or new symptoms;Potential severe COPD; Initial treatment failure; Comorbidities;Number of previous episodes (total/hospitalizations); Older; Lack of family support (GOLD2016); 3. Aged =40 years and =85years, without the limitation of gender; 4. Body weight 40kg to 100kg; 5. Sign the informed consen.
Exclusion criteria
Exclusion criteria: 1. Pregnant women, lactating women; 2. Be allergic to Xuebijing or severe allergic constitution; 3. Acute exacerbation of COPD onset of more than 72 hours; 4. Mental incompetence or active psychiatric illness; 5. Primary diseasesActive tuberculosis, Asthma, Cystic fibrosis, Pulmonary sarcoidosis, Pulmonary interstitial fibrosis, Malignant neoplasms, Blood system diseases, senile dementia, HIV; 6. ComplicationsPulmonary embolism, Shock, DIC, Unstable cardiovascular disease, Upper gastrointestinal bleeding, Pneumothorax, Nyha class IV or higher, Severe liver and kidney dysfunction; 7. AECOPD with severe hypoxemiaoxygenation index <150 or received Endotracheal intubation invasive mechanical ventilation; 8. Participation in another experimental protocol within 30 days of study entry; 9. The investigator judged that the subject could not be completed or should not participate in the trialHemodialysis more than 1 mouthOrgan transplant patients with potential medical dispute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive mechanical ventilation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day mortality;Blood gas analysis (including blood lactic acid);APACHE II score improvement;Laboratory index: blood routine and routine urine, hepatic and renal functions, coagulative function;Inflammatory indicators;immunity indexes;Complications;Length of stay in hospital and ICU; | — |
Countries
China
Contacts
Public ContactLixin Xie
Chinese PLA General Hospital
Outcome results
None listed