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To observe the efficacy of cefuroxime-containing bismuth quadruple regimen in the eradication treatment of Helicobacter pylori, and to evaluate whether it can be used as a remedial treatment for Helicobacter pylori after initial or repeated treatment failure.
Introducing cefuroxime into the remedy treatment of Helicobacter pylori, on the one hand, the investigators will observe whether cefuroxime can replace tetracycline like amoxicillin, on the other hand, the investigators will observe whether it can reduce the rate of adverse effects caused by tetracycline and avoid the allergy of penicillin. If the experiment is successful, it will provide an effective and safe second-line treatment for the majority of patients with failed treatment of Helicobacter pylori.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classic bismuth quadruple treatment group | Active Comparator |
| |
| Cefuroxime containing bismuth quadruple treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefuroxime containing bismuth quadruple treatment | Drug | Cefuroxime containing bismuth quadruple treatment: Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Cefuroxime 500mg bid po, Metronidazole 400mg tid po Treatment duration is 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of success rates after 14 days of eradicate treatment with helicobacter pylori using a bismuth quadruple regimen containing cefuroxime and a classic bismuth quadruple regimen | The comparison of eradication rate (0-100%), it is better to have a higher eradication rate. | The duration of treatment is 14 days. A C13 UBT will be performed 1 month after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The Success rate of cefuroxime-containing bismuth quadruple regimen in the treatment of refractory Helicobacter pylori after 14 days | The eradication rate of new regimen in refractory Helicobacter pylori treatment (0-100%) | A C13 UBT will be performed 1 month after treatment. |
| In vitro culture and drug sensitivity test of Helicobacter pylori were conducted to observe the drug resistance rate of Helicobacter pylori to cefuroxime, tetracycline and metronidazole. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meidong Xu | ShanghaiDongfang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200120 | China |
Guildline in patient consent form
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| Classic bismuth quadruple treatment | Drug | Classic bismuth quadruple treatment: Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Tetracycline 500mg qid po, Metronidazole 400mg tid po Treatment duration is 14 days. |
|
The drug resistance rate of Helicobacter pylori to cefuroxime, tetracycline and metronidazole(0-100%) |
| before the treatment |
| Adverse effect rate and safety of cefuroxime-containing bismuth quadruple regimen and classical bismuth quadruple regimen in patients with refractory Helicobacter pylori. | questionnaire ; follow-up visit | one month after treatment. |