Chronic Pulmonary Infection Complicated with Staphylococcus aureus Colonization
Conditions
Interventions
exposed group:Conventional Western medical treatment and QingJin Yiqi Granules
unexposed group:Conventional Western medical treatment
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Meeting the diagnostic criteria for lower respiratory tract Staphylococcus aureus colonization (confirmed by fluorescence PCR-based pathogen detection and not diagnosed with new-onset pneumonia); 2) Meeting the diagnostic criteria for structural lung disease or being discharged patients admitted to the ICU; 3) Meeting the TCM syndrome differentiation diagnostic criteria for Qi-Yin deficiency syndrome; 4)Aged 18-75 years; 5)Voluntarily participating in the study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1)Except for lower respiratory tract Staphylococcus aureus colonization other confirmed acute diseases related to Staphylococcus aureus will be excluded such as skin and soft tissue infections septicemia endocarditis enteritis meningitis osteomyelitis and toxic shock syndrome caused by Staphylococcus aureus; 2) Clinical pulmonary infection with CPIS score >6 points; 3) Glasgow Coma Scale (GCS) >5 points and APACHE-II score =25 points or GCS <5 points and APACHE-II score =30 points; 4)Sequential Organ Failure Assessment score =9 points; 5)Active lung diseases that impair the ability to diagnose pneumonia such as active tuberculosis or fungal diseases obstructive lung cancer massive pleural effusion or empyema etc; 6) Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia acute myocardial infarction cardiac function grade 3 and above stroke intracerebral hemorrhage etc.); 7)Patients with severe liver diseases (liver cirrhosis bleeding caused by portal hypertension and esophageal-gastric varices etc.) and severe kidney diseases (dialysis kidney transplantation etc.) liver and kidney diseases (ALT AST BUN higher than 1.5 times the upper limit of normal blood Cr higher than 1 times the upper limit of normal) 8) Human immunodeficiency virus (HIV) infected patients; 9)Patients with unclear consciousness various mental illnesses etc. who cannot communicate normally; 10)Pregnant or lactating women and patients with recent pregnancy plans; 11) Patients who have participated in other clinical trials within 1 month before enrollment; 12) Patients known to be allergic to the treatment drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance rate of Staphylococcus aureusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| S. aureus Drug Sensitivity;Mortality Rate;Clinical Pulmonary Infection Score Evaluation;modified Medical Research Council;St George's Respiratory Questionnaire;Chest CT;Routine Blood Test;C-reactive protein;Procalcitonin;lymphocyte subsets;Immunoglobulin;TCM Symptom Score;Blood Gas Analysis;Pulmonary Function;Number of Emergency Department Visits;Number of Hospitalizations;Acute Exacerbation Rate;Readmission Rate;Acute Physiology and Chronic Health Evaluation II;Sequential Organ Failure Assessment Score(SOFA);Glasgow Coma Scale(GCS); | — |
Countries
China
Contacts
Public ContactLIU JIAN
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed