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The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.
Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.
Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with three or more treatment failure, and then evaluates whether adverse effects are tolerable. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14d concomitant therapy | Experimental | The eligible patients received 14-day concomitant therapy, including vonoprazan and three kinds of antibiotics according to the previous eradication regimens and antibiotic use. Antibiotics are selected from Amoxicillin, Tetracycline, Furazolidone, Levofloxacin, Clarithromycin, Tinidazole, Metronidazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| three kinds of antibiotics | Drug | All patients were educated carefully about the medical instructions, including the duration of treatment, possible side effect, the necessity of completing the full 14-day course. |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate | Six weeks after completion of treatment,number of patients get H.pylori eradicated will be investigated.Then eradication rate will be calculated by using intention-to-treat analysis and per-protocol analysis | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| The rates of adverse events | At the follow-up,adverse events complained by patients will be recorded by an inde pendent researcher, meanwhile a 8point visual analog scale (VAS) was used to evaluate severity of adverse events. | 6 month |
| Compliance |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.
| 6 month |