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Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BQT |
| ||
| PBM4M4 |
| ||
| PBM3M3 |
| ||
| PBM2M4 |
| ||
| PBM2M3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BQT | Drug | PPI(esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, tetracycline 500 mg four times a day, and metronidazole 400 mg four times a day |
| 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) | Within six weeks after completion of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who failed at least two courses of H. pylori treatment containing clarithromycin, nitroimidazoles, fluoroquinolones, and/or amoxicillin, and received 14-day tetracycline/minocycline, metronidazole-containing bismuth quadruple therapy were identified. Patients with the following criteria were excluded: (1) naive to H. pylori treatment; (2) under 18 or over 80 years; (3) history of gastrectomy; (4) administration of antibiotics, bismuth, acid suppressants, or Chinese herb medicine in the preceding 12 weeks; (5) severe systemic diseases or malignancy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | None Selected | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39306798 | Derived | Huang Y, Qiu S, Guo Y, Chen J, Li M, Ding Z, Zhang W, Liang X, Lu H. Optimization of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Real-World Evidence Study. Helicobacter. 2024 Sep-Oct;29(5):e13138. doi: 10.1111/hel.13138. |
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| ID | Term |
|---|---|
| C562573 | cyclopia sequence |
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| PBM4M4 | Drug | PPI(esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg four times a day, and metronidazole 400 mg four times a day |
|
| PBM3M3 | Drug | PPI(esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg three times a day, and metronidazole 400 mg three times a day |
|
| PBM2M4 | Drug | PPI(esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg twice daily, and metronidazole 400 mg four times a day |
|
| PBM2M3 | Drug | PPI(esomeprazole or vonoprazan), bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg twice daily, and metronidazole 400 mg three times a day |
|
| Compliance rate | Compliance was defined as poor when they had taken less than 80% of the total medication | Within six weeks after completion of therapy |