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To compare the performance of four treatment regimens for radical treatment of Helicobacter pylori, evaluating the efficacy, safety, patient compliance, and socioeconomic evaluation of the four regimens. The four treatment regimens included (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline.
A single-center, prospective, open-label, parallel control design was conducted to enroll 100 patients with confirmed Helicobacter pylori infection. Patients were randomly divided into four groups, respectively accept four treatment regimens including (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline. The effectiveness, safety and compliance of the four regimens were compared, and the cost-benefit analysis of the different regimens was conducted. The purpose of this study was to explore the most appropriate treatment plan for radical treatment of Helicobacter pylori .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1: Vonoprazan Fumarate + amoxicillin + doxycycline | Experimental |
| |
| Group2: Vonoprazan Fumarate + furazolidone + doxycycline | Experimental |
| |
| Group3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline | Experimental |
| |
| Group4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group1 Vonoprazan Fumarate + amoxicillin + doxycycline | Drug | Vonoprazan Fumarate + amoxicillin + doxycycline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of Hp at one time | The UBT test was performed to determine whether Hp was eradicated. No antibiotics, bismuth, or PPI were taken during this period. ITT analysis and PP analysis were used. | 43 or 57 days after the initiation of eradication therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-benefit analysis | The drug cost of the two treatment options was calculated. According to the HP eradication rate, markov model was used to conduct cost-benefit analysis of the two methods, and determine which method was more cost-effective from an economic perspective. | 43 or 57 days after the initiation of eradication therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Wang, MD,PhD | Contact | +8613974889301 | wangxiaoyan@csu.edu.cn | |
| Zinan Zhang, MD | Contact | +8615273169959 | classroom0705@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The third Xiangya Hospital of central south University | Recruiting | Changsha | Hunan | 410003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37214450 | Derived | Zhang Z, Liu F, Ai F, Chen X, Liu R, Zhang C, Fang N, Fu T, Wang X, Tang A. The efficacy and mechanism of vonoprazan-containing triple therapy in the eradication of Helicobacter pylori. Front Pharmacol. 2023 May 5;14:1143969. doi: 10.3389/fphar.2023.1143969. eCollection 2023. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 23, 2021 |
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| Group2 Vonoprazan Fumarate + furazolidone + doxycycline | Drug | Vonoprazan Fumarate + furazolidone + doxycycline |
|
| Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline | Drug | esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline |
|
| Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline | Drug | esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline |
|
| Adverse events |
Adverse drug events, significant laboratory outliers, and new diseases emerging during the study |
| 43 or 57 days after the initiation of eradication therapy |
| Nov 7, 2021 |
| Prot_SAP_ICF_001.pdf |
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D004318 | Doxycycline |
| D005664 | Furazolidone |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005663 | Furans |
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