Treatment for the acute exacerbation phase of chronic obstructive pulmonary disease, which is clinically manifested by worsening symptoms such as cough, expectoration, wheezing or dyspnea.
Conditions
Interventions
Fixed-dose group: Administer hormones at the dose recommended in the GOLD 2025 Guidelines plus basic treatment:Methylprednisolone Sodium Succinate
Modified Formula Group: Administration of corticosteroids at the dose calculated by the modified formula plus basic treatment:Methylprednisolone Sodium Succinate
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Hospitalized AECOPD patients aged 40 years or older, regardless of gender. 2.The diagnostic criteria for AECOPD require meeting at least 2 of the following conditions: 1) Dyspnea beyond the daily variability range; 2) Increased frequency of cough or volume of sputum; 3) Or the presence of purulent sputum. 3.Having given their fully informed consent after understanding the informed consent form, the participants voluntarily agree to participate in the clinical study, sign the informed consent form, and are willing to abide by the trial procedures. 4.Medical records demonstrating a history of COPD for >= 12 months must be available at the time of screening; 5.Current or former smokers with a smoking history of >= 10 pack-years; 6.Regular use of background COPD maintenance therapies (LABA+ICS, LABA+LAMA+ICS, LABA+LAMA) for >= 3 months prior to screening, with a stable treatment regimen and dosage for >= 1 month; 7.Having experienced moderate to severe AECOPD twice or more within 1 year prior to screening, during the period of regular use of background COPD maintenance therapies (with a stable treatment regimen and dosage for more than 1 month); 8.An expected survival period of more than 12 months at the time of screening;
Exclusion criteria
Exclusion criteria: 1.Patients with comorbid asthma or pulmonary tuberculosis; 2.Systemic use of corticosteroids within one month prior to enrollment; 3.Presence of clinical or radiological evidence of pneumonia, pneumothorax, or pulmonary embolism; 4.Left heart failure requiring treatment with inotropic agents or vasoactive drugs for control; 5.Uncontrolled hypertension; 6.Uncontrolled diabetes mellitus; 7.Refusal to sign the informed consent form; 8.Immediate endotracheal intubation upon admission and admission to the RICU; 9.Patients with acute myocardial infarction, unstable angina pectoris, stroke (including transient ischemic attack), severe arrhythmia, or other cardiovascular diseases (e.g., pulmonary embolism, deep venous thrombosis) within 6 months prior to enrollment; 10.Patients with malignant tumors; 11.Long-term regular use of oxygen therapy (more than 12 hours per day); 12.Arterial blood gas analysis indicating a pH 9.3 kPa (70 mmHg); 13.Neuromuscular disorders; 14.Hypersensitivity to hormones or a history of significant adverse reactions following hormone administration; 15.Age < 40 years old;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure rate; | — |
Countries
China
Contacts
Public ContactLi Li
Army Medical Center of PLA
Outcome results
None listed