Helicobacter pylori
Conditions
Interventions
Tegoprazan-Based Dual Therapy (I) Group:Tegoprazan combined with furazolidone
Tegoprazan-Based Dual Therapy (II) Group:Tegoprazan combined with tetracycline
Sponsors
the Affiliated Hospital of Putian University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Helicobacter pylori infection: Patients need to confirm the diagnosis of Helicobacter pylori infection by at least two of the following methods to ensure the accuracy of diagnosis: (1) The 13C or 14C urea breath test is positive, and the test value is higher than the normal reference range (e.g., the DOB value of the 13C urea breath test >=4.0); (2) The gastroscopy and rapid urease test were positive, and the gastric mucosa could be seen to have different degrees of inflammation, erosion and other lesions under gastroscopy, and the discoloration reaction of the rapid urease test reagent met the positive criteria; (3) Helicobacter pylori was found in histopathological examination, and the typical morphology of Helicobacter pylori was observed under the microscope after special staining (such as Warthin-Starry silver staining, Giemsa staining, etc.) through gastric mucosal biopsy. 2. Age range: between 18 and 60 years old. This age group is relatively stable and can tolerate drug reactions during treatment. At the same time, patients of different ages are covered, which makes the results of the study more universal across different age groups. For example, young people aged 18-35 years have a rapid metabolism and may have different metabolism and response to drugs than those of middle-aged and older people aged 50-75 years. 3. Signing of informed consent: Patients or their legal representatives voluntarily sign informed consent after fully understanding the research purpose, methods, possible risks and benefits. The content of the informed consent form should detail the research process, including the treatment plan, dosage and time of medication, follow-up arrangements, etc., as well as possible adverse reactions and countermeasures, so as to ensure that patients make a fully informed decision to participate in the study. 4. No serious underlying diseases: patients do not have serious cardiopulmonary dysfunction, liver and kidney failure, malignant tumors and other underlying diseases that may affect the treatment effect or increase the risk of the study. The specific judging criteria are as follows: In terms of cardiopulmonary function, the cardiac function grade should be in NYHAI.-II., and the left ventricular ejection fraction (LVEF) assessed by cardiac ultrasound should be >=50%; In pulmonary function tests, the percentage of forced expiratory volume occupied by force in 1 second (FEV1/FVC) was >=70%, and there were no severe acute exacerbations of chronic obstructive pulmonary disease. In terms of liver and kidney function, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) did not exceed 1.5 times the upper limit of normal, serum creatinine (SCr) was within the normal reference range (53-106 µmol/L for men and 44-97 µmol/L for women), or the estimated glomerular filtration rate (eGFR) >=60 ml/(min·1.73 m^2). 5. In terms of malignant tumors, patients should have no history of previous malignant tumors, or have a history of previous malignant tumors, but have reached the clinical cure criteria (such as tumor-free survival for more than 5 years after surgical resection, and no signs of tumor recurrence were found in recent imaging examinations).
Exclusion criteria
Exclusion criteria: 1. Allergy to the study drug: Patients with known allergy to tegolasen, furazolidone, tetracycline or other related drugs are prohibited from enrollment. For patients with drug allergy symptoms (such as rash, itching, dyspnea, laryngeal edema, etc.), the type of allergic drug should be further confirmed to avoid serious adverse reactions caused by drug allergy, which will affect the patient's health and research process; 2. Recent use of related drugs: use of antibiotics, bismuth, proton pump inhibitors, potassium competitive acid blockers and other drugs that may affect the test results of Helicobacter pylori or interfere with the efficacy of the study drug within 4 weeks before enrollment. Specific drugs include amoxicillin, metronidazole, clarithromycin, bismuth potassium citrate, omeprazole, lansoprazole, vornorrasine, etc., because these drugs may change the activity of Helicobacter pylori or the balance of microflora in the body, resulting in inaccurate test results and affecting the judgment of the true efficacy of the study drug; 3. Pregnant or lactating females: Pregnant or lactating females were not included in the study due to the safety of the fetus and infant. The pregnancy and lactation status of female patients can be accurately determined by asking for a detailed menstrual history and performing pregnancy tests (such as urine pregnancy test and blood ß-HCG test). The safety of the study drug on the fetus and infant has not been established to avoid potential risks; 4. Mental illness or cognitive impairment: patients with severe mental illness (such as schizophrenia, manic-depressive disorder, etc.) or cognitive impairment (such as Alzheimer's disease, cognitive dysfunction caused by severe brain injury, etc.), and cannot cooperate with the completion of various examinations, treatments and follow-up in the course of the study. The mental and cognitive status of patients is assessed through professional psychiatric assessment scales (such as Mini-Mental State Examination (MMSE), Hamilton Depression Rating Scale (HAMD, etc.) to ensure that patients can accurately understand and follow the requirements of the study and ensure the reliability of the research data. 5. Vulnerable groups: mainly including children, the elderly, the disabled, the mentally ill, the unemployed, the poor, laid-off workers, those seeking help in disasters, migrant workers, informal workers, and those in a disadvantaged position in labor relations. Although this study did not deliberately target vulnerable groups, the characteristics and rights and interests of various groups of people were fully considered in the enrollment and research process, and it was strictly implemented in accordance with the established standards to ensure the scientificity and ethics of the study. 6. Poor compliance: According to the judgment of the investigator, the patient may have compliance problems, such as not being able to take medication on time, not cooperating with follow-up, etc. For patients who are busy with work, often travel or have bad lifestyle habits (such as long-term alcoholism, drug abuse, etc.) that may affect the timely medication and follow-up, it is necessary to carefully evaluate their compliance, good compliance is the key to ensure the accuracy of the research results, and patients with poor compliance may lead to bias in the study data and affect the research conclusions; 7. Other special circumstances: If the patient has a history of gastrointe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug-related adverse events; | — |
Countries
China
Contacts
Public ContactConghua Song
the Affiliated Hospital of Putian University
Outcome results
None listed