Chronic obstructive pulmonary disease
Conditions
Interventions
Oral staphylococcus albicans tablet group:Staphylococcus albicans tablets 0.3 mg, 4 tablets each time, 3 times a day for 3 months
Oral placebo group:(0.3 mg/ tablet, 4 tablets each time, 3 times a day, Shandong Qilu Pharmaceutical Co., LTD.), the course of treatment was 3 months.
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old (including both ends of the boundary), no gender limitation; 2. Patients hospitalized in general ward during acute exacerbation of chronic obstructive pulmonary disease; 3. Patients with chronic obstructive pulmonary disease comprehensively assessed in the B/C/D group (according to GOLD 2021); 4. At least one history of acute exacerbation of COPD within the past year; 5. Subjects with smoking history (>= 10 packs/year); 6. Patients (or their legal representatives) must sign and date informed consent, indicating that they understand the purpose and procedures of the study and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Have been admitted to ICU, such as hypoxemia (PaO2 60 mmHg), severe infectious pneumonia, etc.; 2. Patients with pulmonary tuberculosis, bronchiectasis or lung surgery; 3. Patients with new tumors or a history of tumors (except localized basal cell carcinoma of the skin), with or without treatment, recurrence or metastasis within the past 5 years; 4. Prior (6 months prior to study) or concurrent use of immunostimulants (including thymosin, interferon, transfer factor, BCG polysaccharide, pneumonia vaccine and any bacterial extract such as Biostim, except influenza vaccine) or immunosuppressants; 5. Patients who are participating in or have participated in an interventional clinical trial within 30 days; 6. Patients who are fertile and have not taken effective contraceptive measures (barrier contraception or hormonal contraception; barrier contraception includes: cervical cap, condom, intrauterine device, vaginal sponge plug, spermicide; hormonal contraception includes: birth control pills); 7. According to the judgment of the researcher, the subject is not suitable for study observation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Readmission rate within 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptom Score;Changes of T lymphocyte subsets, B lymphocytes, natural killer cells (NK cells) and serum immunoglobulin (IgG, IgA, lgM, C3 and C4) in peripheral blood ;Duration of clinical use of anti - infective drugs;mMRC(modified British medical research council) score;Days of exacerbations, and severity of exacerbations;BSI(bronchiectasis severity index) score;Number of exacerbations;Proportion of patients with exacerbations; | — |
Countries
China
Contacts
Public ContactSong Yuanlin
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed