Traumatic brain injury
Conditions
Interventions
Conventional treatment group:The treatment received by the conventional treatment group included: respiratory support
improvement of lung drainage and expectoration
supportive therapy
and prophylaxis and monitoring.A placebo, 200 mg/day, orally for a fortnight was used in contrast to the experimental group.
Sponsors
Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with TBI clearly diagnosed through history taking and imaging (CT, etc.); GCS score 65 years old, gender is not limited; 3. Time period from onset to admission <= 72h; 4. BALF flow test: HLA-DR+ neutrophil percentage <2%; 5. Liver and kidney functions are basically normal, or mildly abnormal but do not affect drug metabolism and excretion at the study dose, with ALT and AST <= 2 times the upper limit of normal, and blood creatinine <= 1.5 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. Non-supratentorial intracerebral hemorrhage; 2. Secondary intracerebral hemorrhage (secondary causes such as aneurysms, vascular malformations, hemorrhagic transformation of cerebral infarction, tumors, drug-related or abnormal coagulation mechanisms, etc.); patients with brain herniation; 3. Severe TBI or with severe basilar skull fractures; 4. TBI patients with concurrent injuries to other organs; 5. Patients judged by the researcher to have poor compliance, mental problems preventing informed consent, or whose families refuse to participate in the study; 6. Patients allergic to this drug; 7. Patients with abnormal heart, liver, or kidney function, or with a history of heart, liver, or kidney diseases; 8. Patients who may be pregnant in the near future, are already pregnant, are in the lactation period, or refuse to use contraception within six months of administration; patients with intrauterine device pregnancy and suspected ectopic pregnancy; 9. Patients with a history of uncontrollable infection or severe infectious diseases; 10. Patients who have received a vaccine within 30 days of administration; 11. Patients currently with diabetes, cardiovascular diseases, a history of pulmonary diseases, immunodeficiency diseases, or other serious diseases that may interfere with outcome assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of pneumonia during hospitalisation in patients with TBI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of HLA-DR+ neutrophils in BALF;Expression of inflammatory factors in BALF;Time from study inclusion to diagnosis of pneumonia;Days without antibiotic use;Improved Rankin scores; | — |
Countries
China
Contacts
Public ContactShi Wei
Affiliated Hospital of Nantong University
Outcome results
None listed