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A 14-day high-dose Ilaprazole-Amoxicillin dual therapy is non-inferior to bismuth quadruple therapy, with fewer side effects and better compliance in patients infected with H. pylori.
In a research conducted by Jianping Cheng et al, the 14-day high-dose Ilaprazole-Amoxicillin dual therapy (HT) treatment exhibited superior efficacy, safety, and treatment compliance when compared to bismuth quadruple therapy (BQT) for H. pylori eradication. Investigators aimed to compare HT vs. BQT as the primary treatment for H. pylori. This prospective, single-center, randomized clinical controlled trial enrolled 225 consecutive patients infected with H. pylori.
Participants were assigned to either the HT group (10 mg Ilaprazole twice daily; 1000 mg Amoxicillin three times daily) or the BQT group (2.6 g compound bismuth aluminate granules three times daily; 5 mg Ilaprazole twice daily; 1000 mg Amoxicillin twice daily; 500 mg Clarithromycin twice daily) for 14 days. Eradication success was evaluated using the 13C-urea breath test 4 weeks post-treatment. The key endpoint focused on the H. pylori elimination rate, with safety and compliance as secondary endpoints.
Of the 228 subjects screened, 225 were randomized. The intention-to-treat (ITT) and per-protocol (PP) analyses revealed eradication rates of 76.3% and 61.3%, respectively, in the HT and BQT groups (p = 0.015). When compared to BQT, HT exhibited lower rates of adverse events (27.2% vs. 81.8%, p = 0.002). The most frequently encountered adverse event was a bitter aftertaste (3.5% vs. 60.4%, p < 0.001).
No profound difference in compliance was witnessed between the two groups (89.5% vs. 92.8%, p = 0.264). The 14-day HT therapy showcased superior effectiveness in eliminating H. pylori and enhanced safety and adherence when contrasted with BQT. Hence, HT can serve as a safe and efficient alternative for H. pylori mitigation. These results suggest the potential adoption of the 14-day HT as a first-line regimen for empirical treatment.
Frontiers in Pharmacology
Efficacy and safety of high-dose ilaprazole-amoxicillin dual therapy for Helicobacter pylori eradication: a prospective, single-center, randomized trial
Jianping Cheng et al.
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