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Quantitative Polymerase Chain Reaction (qPCR)-Based Rapid Diagnosis of Helicobacter pylori Infection and Antibiotic Resistance
Published on: July 28, 2023
Vonoprazan-based dual and quadruple therapy with varying duration for Helicobacter pylori eradication: A multicenter,
Kunping Ju1, Hanyue Zhao1, Leina Guo2
1Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China; Shandong Provincial Clinical Research Center for digestive disease, Shandong, China; Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China; Robot engineering laboratory for precise diagnosis and therapy of GI tumor, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Objectives:
The study was conducted to assess the effectiveness and safety of two simplified dual and quadruple therapies compared with the guideline-recommended 14-day dual therapy for first-line Helicobacter pylori treatment.
Methods:
This randomised controlled trial (RCT) enrolled treatment-naïve patients across six clinical centres. The study randomly allocated participants equally to one of three regimens: VA-14 (vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days), VA-10 (same drugs with VA-14 but for 10 days), and VBAT-7 (vonoprazan 20 mg twice daily, tetracycline 500 mg three times daily, amoxicillin 1000 mg twice daily, and bismuth potassium citrate 220 mg twice daily for 7 days). The 13C-urea breath test was conducted to confirm eradication at least six weeks after treatment.
Results:
Out of 387 patients who were eligible, 330 were assigned randomly. The VBAT-7 group exhibited non-inferior efficacy to the VA-14 group, with the eradication rates of 90.0% (99/110) and 91.8% (101/110) in intention-to-treat (ITT) analysis (P = 0.017), 92.5% (99/107) and 94.4% (101/107) in modified ITT analysis (P = 0.008), and 93.3% (98/105) and 95.2% (100/105) in per-protocol (PP) analysis (P = 0.006). However, the non-inferiority of efficacy between VA-10 and VA-14 was not established. The groups did not show significant variations in adverse events or compliance.
Conclusions:
VBAT-7 demonstrated non-inferiority to VA-14 and represents a potential first-line option for first-line H. pylori treatment. The VA-10 regimen achieved acceptable eradication in PP analysis but did not statistically meet the non-inferiority criterion.
Trial Registration:
ClinicalTrials.gov ID: NCT06723197.
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