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Helicobacter pylori is an important pathogenic factor for gastrointestinal diseases such as gastritis, peptic ulcer, gastric mucosa-associated lymphoid tissue lymphoma and gastric cancer.However, with the increasing use of antibiotics, antibiotic resistance of Helicobacter pylori continues to rise. In this study, we used egg yolk antibody combined with bismuth quadruple therapy to treat patients with Helicobacter pylori infection, and observed the eradication rate of Helicobacter pylori, the relief of clinical symptoms and the incidence of adverse reactions.
Background: Helicobacter pylori is an important pathogenic factor for gastrointestinal diseases such as gastritis, peptic ulcer, gastric mucosa-associated lymphoid tissue lymphoma and gastric cancer.However, with the increasing use of antibiotics, antibiotic resistance of Helicobacter pylori continues to rise. Therefore, it is of great significance to explore new methodsfor the treatment of Helicobacter pylori.
Methods: A total of 200 patients who failed to eradicate Helicobacter pylori were included and randomly divided into control group and study group. The research group was treated with egg yolk antibody combined with bismuth quadruple therapy, and the research group was treated with bismuth quadruple therapy for a total of 14 days. The eradication rate of Helicobacter pylori was calculated according to intention-to-treat and by-protocol analysis, and the symptom remission rate and adverse reactions were recorded during the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | 14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth |
|
| control group | Active Comparator | 14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth |
|
| the case group | Experimental | 14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline |
|
| the control group | Active Comparator | 14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth | Drug | Yolk antibody: 7g*10 board/box, produced by Beijing Yucheng Health Technology Co., Ltd. Ilaprazole: 5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc. Amoxicillin: 250mg*50 capsules/box, produced by Hainan General Sanyo Pharmaceutical Co., Ltd. Clarithromycin: 500mg*6 capsules/box, produced by Henan Fusen Pharmaceutical Co., Ltd. Furazolidone: 0.1g*28 pieces/bag, produced by Tianjin Lisheng Pharmaceutical Co., Ltd. Doxycycline: 0.1g*10 capsules/box, produced by Jiangsu Yongxin Pharmaceutical Co., Ltd. bismuth :55mg*36 capsules/box, produced by Shanxi Xinbaoyuan Pharmaceutical Co.,Ltd |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of Helicobacter pylori | Detected by 13C-urea breath test (13C-UBT) or 14C-urea breath test (14-UBT), Eradication rate=(Number of successful eradication / total number of eradication)*100% | At four weeks after the completion of treatment (day 42±3) |
| Measure | Description | Time Frame |
|---|---|---|
| Relief of clinical symptoms (Symptom relief rate) | Assessment by questionnaire: Symptom relief rate = (number of people with relief of symptoms/total number of people) *100% | After drug treatment (day 14±3) and during follow-up (day 42±3) |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CANXIA XU | Contact | +8613786176248 | xucanxia@163.com |
| Name | Affiliation | Role |
|---|---|---|
| SHA CHENG | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
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|
| IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth | Drug | Ilaprazole: 5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc. Amoxicillin: 250mg*50 capsules/box, produced by Hainan General Sanyo Pharmaceutical Co., Ltd. Clarithromycin: 500mg*6 capsules/box, produced by Henan Fusen Pharmaceutical Co., Ltd. Furazolidone: 0.1g*28 pieces/bag, produced by Tianjin Lisheng Pharmaceutical Co., Ltd. Doxycycline: 0.1g*10 capsules/box, produced by Jiangsu Yongxin Pharmaceutical Co., Ltd. bismuth :55mg*36 capsules/box, produced by Shanxi Xinbaoyuan Pharmaceutical Co.,Ltd |
|
| Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline | Drug | Yolk antibody: 7g*10 board/box, produced by Beijing Yucheng Health Technology Co., Ltd. Ilaprazole: 5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc. Amoxicillin: 250mg*50 capsules/box, produced by Hainan General Sanyo Pharmaceutical Co., Ltd. Clarithromycin: 500mg*6 capsules/box, produced by Henan Fusen Pharmaceutical Co., Ltd. Furazolidone: 0.1g*28 pieces/bag, produced by Tianjin Lisheng Pharmaceutical Co., Ltd. Doxycycline: 0.1g*10 capsules/box, produced by Jiangsu Yongxin Pharmaceutical Co., Ltd. |
|
| IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth | Drug | Ilaprazole: 5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc. Amoxicillin: 250mg*50 capsules/box, produced by Hainan General Sanyo Pharmaceutical Co., Ltd. Clarithromycin: 500mg*6 capsules/box, produced by Henan Fusen Pharmaceutical Co., Ltd. Furazolidone: 0.1g*28 pieces/bag, produced by Tianjin Lisheng Pharmaceutical Co., Ltd. Doxycycline: 0.1g*10 capsules/box, produced by Jiangsu Yongxin Pharmaceutical Co., Ltd. bismuth :55mg*36 capsules/box, produced by Shanxi Xinbaoyuan Pharmaceutical Co.,Ltd |
|
follow up to get the percentage of people with adverse reactions |
| After drug treatment (day 14±3) |
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D005664 | Furazolidone |
| D004318 | Doxycycline |
| D001729 | Bismuth |
| 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 |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005663 | Furans |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
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