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Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetracycline Bismuth Quadruple Therapy | Active Comparator | Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid |
|
| Rifabutin Triple Therapy | Experimental | Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid |
|
| Dual Therapy | Experimental | Vonoprazan 20mg bid, amoxicillin 1000mg tid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Proton pump inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value). | Six weeks after completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse effects | The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or severe" (causing considerable interference with daily activities). In addition, blood test were messured to access function of liver and kidney. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200127 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41732217 | Derived | Huang Y, Chen JN, Qiu SH, Guo YX, Li MX, Gao YN, Liang X, Han YH, Xu P, Wang J, Lu H. Vonoprazan-amoxicillin dual, rifabutin-based triple, and bismuth quadruple therapies for Helicobacter pylori rescue treatment: a multicentre, open-label, non-inferiority randomised trial. Lancet Reg Health West Pac. 2026 Feb 12;68:101815. doi: 10.1016/j.lanwpc.2026.101815. eCollection 2026 Mar. |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D013752 | Tetracycline |
| D008795 | Metronidazole |
| D000658 | Amoxicillin |
| D017828 | Rifabutin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Bismuth Potassium Citrate | Drug | Gastric mucosal protective drug with anti-H. pylori effect |
|
| Tetracycline | Drug | Antibiotics for H. pylori eradication |
|
| Metronidazole | Drug | Antibiotics for H. pylori eradication |
|
| Amoxicillin | Drug | Antibiotics for H. pylori eradication |
|
| Rifabutin | Drug | Antibiotics for H. pylori eradication |
|
| Within 7 days after completion of therapy |
| Compliance rate | Compliance was defined as poor when they had taken less than 80% of the total medication | Within 7 days after completion of therapy |
| Shanghai Songjiang District Central Hospital |
| Shanghai |
| Shanghai Municipality |
| China |
| The Second Affiliated Hospital of Zhejiang University school of Medicine | Hangzhou | Zhejiang | China |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |