peptic ulcers bleeding
Conditions
Interventions
Control group:pantoprazole sodium injection
experimental group:S-(-)-pantoprazole sodium injection
Sponsors
Nanfang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) aged 18 to 65 years male and female; (2) hemorrhage of upper digestive tract, such as hematemesis and / or black stool, was found within 48 hours before screening; (3) non-varicose gastric and / or duodenal ulcer complicated with upper gastrointestinal bleeding was diagnosed by gastroscopy within 48 hours before entering the group; (4) the grade of modified Forrest was Ia, Ib, IIa, IIb, IIc. Multiple ulcers were judged by high Forrest grade, and the patients with Ia needed endoscopy to stop bleeding. Patients with Ib, IIa, IIb, IIc were determined by the subjectsundefined condition; (5) patients who were not suitable for oral proton pump inhibitor (PPI); (6) those who volunteered to participate in the clinical trial and sign written informed consent.
Exclusion criteria
Exclusion criteria: (1) a history of allergy to the test drug and its components; (2) those who underwent gastrectomy, gastroenterostomy and gastric vagotomy; (3) stress ulcer, cancer ulcer and ulcer bleeding caused by non-steroidal anti-inflammatory drugs; (4) gastrinoma; (5) patients with severe condition needing drug shock therapy or clinical shock; (6) those who need surgical treatment for this disease; (7) those who had used PPI drugs within 48 hours before entering the group; (8) drugs that may interfere with the evaluation of disease efficacy, including somatostatin; acid suppressants (H2 receptor antagonists: ranitidine, famotidine, etc.; other PPI: omeprazole, rabeprazole, etc.); Keywords gastrointestinal mucosal protectants (such as sucralfate tablets); antacid drugs (such as Daxi); anticoagulants (e.g. heparin, warfarin, vitamin K antagonists, etc.); antiplatelet drugs (aspirin, clopidogrel, etc.); Keywords hemostatic drugs (for example, p-aminomethylbenzoic acid, phenolsulfonethylamine, batroxobin, Yunnan white medicine and thrombin, etc.); glucocorticoid; Non-steroidal anti-inflammatory drugs. (9) patients with abnormal coagulation function (platelet upper limit of 3 seconds or APTT > normal value of 10 seconds) or those receiving low dose heparin therapy; (10) abnormal examination of liver and kidney function (ALT,AST = normal value: 1.5 times > upper limit of normal value); (11) severe heart, lung, malignant, hematopoietic and hematopoietic diseases, or severe infectious diseases such as sepsis or sepsis; (12) patients with neurological, psychiatric disorders who are unable to cooperate or are unwilling to cooperate. (13) patients with acute alcoholism or alcohol dependence; (14) those who are prone to drug abuse or drug dependence; (15) pregnant, lactating or recently planned births; (16) other clinical trials were conducted within 3 months before admission; (17) the researchers do not consider it appropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective hemostasis rate at 72 hours after medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective hemostasis rate at 72 hours after medication;transfusion volume within 5 days;bleeding resulted in re-endoscopic diagnosis and surgical operation rate within 5 days.; | — |
Countries
China
Contacts
Public ContactLiu Side
Nanfang Hospital, Southern Medical University
Outcome results
None listed