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The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.
Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies.
H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose dual therapy group | Experimental | esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group |
|
| Furazolidone-based quadruple therapy | Active Comparator | furazolidone 100mg bid + amoxicillin 1000mg bid + esomeprazole 20mg bid + bismuth potassium citrate 1000mg(220mg of bismuth) bid were used in the Furazolidone-based quadruple therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esomeprazole plus amoxicillin | Drug | amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| eradication rate | eradication rate of H pylori, presenting with negative results on the 13C-UBT test | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of the adverse events | incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever. | 42 days |
| compliance rate of the drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Chen, MD | Contact | 8613764633539 | chen.jie5@zs-hospital.sh.cn | |
| Chengzhao Weng, MD | Contact | 8615859253190 | weng.chengzhao@zsxmhospital.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Jiang, MD | Xiamen branch of Zhongshan Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Xiamen Branch | Recruiting | Xiamen | 86361015 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30807294 | Background | Yang J, Zhang Y, Fan L, Zhu YJ, Wang TY, Wang XW, Chen DF, Lan CH. Eradication Efficacy of Modified Dual Therapy Compared with Bismuth-Containing Quadruple Therapy as a First-Line Treatment of Helicobacter pylori. Am J Gastroenterol. 2019 Mar;114(3):437-445. doi: 10.14309/ajg.0000000000000132. | |
| 31111580 | Background |
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Individual participant data will be available to other researchers. We may balance the potential benefits and risks for each request and then provide the data that could be shared.
The data will be available once the results have been uploaded in the PRS system and will be available for 2 years.
Emails could be sent to the emails below to obtain the shared data: chen.jie5@zs-hospital.sh.cn, weng.chengzhao@zsxmhospital.com
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D000658 | Amoxicillin |
| D005664 | Furazolidone |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole | Drug | amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days |
|
|
Compliance was defined as good when they had taken more than 80% of the total medication.
| 42 days |
| Yu L, Luo L, Long X, Liang X, Ji Y, Graham DY, Lu H. High-dose PPI-amoxicillin dual therapy with or without bismuth for first-line Helicobacter pylori therapy: A randomized trial. Helicobacter. 2019 Aug;24(4):e12596. doi: 10.1111/hel.12596. Epub 2019 May 20. |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D005663 | Furans |