Stress ulcer in severe trauma
Conditions
Interventions
Experimental group:Experimental group: On the basis of conventional comprehensive treatment, patients will receive Yunnan Baiyao capsules [0.25 g, 2 capsules per dose, 4 times daily, orally
(for critically ill or comatose patients, the same dose can be administered via nasogastric tube)] plus the insurance pellet [1 pellet every two days, orally
(for critically ill or comatose patients, the same dose can be administered via nasogastric tube)], for a continuous treatment period of 7 days.
Control group:Control group: On the basis of conventional comprehensive treatment, patients will receive omeprazole (0.2 g, 1 tablet per dose, twice daily) for a continuous treatment period of 7 days.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Selection criteria 1.1 Indications for prophylaxis of stress ulcers: (Those who meet any of the following high-risk conditions are eligible for prophylaxis of stress ulcers) (1) Assess the severity of trauma patients according to the Acute Physiology and Chronic Health Status Scoring System II. (APACHE II., see Annex 1), and screen the population that meets the severe trauma level (>=16 points); (2) Mechanical ventilation exceeds 48 hours; (3) Primary coagulation mechanism disorders [international normalized ratio (INR)>1.5, platelet 2 times the normal value]; (4) History of gastrointestinal ulcer or upper gastrointestinal bleeding within 1 year; (5) Severe craniocerebral and cervical spinal cord trauma (GCS score 30%); (7) Various difficult and complex surgeries (grade 3 and 4 surgeries or operation time > 4 hours); (8) Acute renal failure or acute liver failure; (9) Acute respiratory distress syndrome (ARDS); (10) Shock or persistent hypotension; (11) Sepsis; (12) Cardiovascular and cerebrovascular accidents; (13) Any two of the following are met: 1) ICU stay > 1 week; 2) The duration of fecal occult blood > 3 days; 3) high-dose use of glucocorticoids (hydrocortisone at a dose > 250mg/d or other equivalent doses: hydrocortisone 250mg=prednisone 62.5mg=methylprednisolone 50mg=dexamethasone 9.375mg); 4) Concomitant use of non-steroidal anti-inflammatory drugs; 1.2 18 years old<=age<=80 years; 1.3 Patients or their families voluntarily participate in this study and sign the informed consent form. (Inclusion criteria 1.1 above refer to clinical indications for stress ulcer prophylaxis)
Exclusion criteria
Exclusion criteria: 2. Exclusion Criteria Subjects meeting any of the following criteria will be excluded. Subjects meeting any of the following conditions are not eligible for inclusion in the study: (1) Presence of severe underlying diseases, such as malignant tumors, history of severe organic disorders, or severe multiple organ failure; (2) Absence of the aforementioned high-risk factors and undergoing simple surgery; (3) Positive pregnancy test, pregnant women, or breastfeeding women; (4) Patients with psychiatric disorders who are unable to cooperate with treatment; (5) Patients who have resumed oral intake (including enteral nutrition) postoperatively should not continue using proton pump inhibitors; (6) Patients with known allergies to the study medication; (7) Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occult blood test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Blood Count;Biochemical Test;Gastrin-17;C-reactive protein;Erythrocyte Sedimentation Rate;Interleukin-6; | — |
Countries
China
Contacts
Public ContactGuanglin Wang
West China Hospital of Sichuan University
Outcome results
None listed