Short-term outcomes and intermediate-term follow-up ofHelicobacter pyloriinfection treatment for naïve patients: a retrospective observational study

Abstract

ObjectivesTo explore the outcomes of Helicobacter pylori infection treatments for naïve patients in the real-world settings.DesignA retrospective observational study.SettingSingle tertiary level academic hospital in China.ParticipantsWe identified patients initially receiving quadruple therapy for H. pylori infection from 2017 to 2020 in whom eradication was confirmed (n=23 470).Primary outcomeEfficacy of different initial H. pylori infection treatments.Secondary outcomeResults of urea breath test (UBT) after H. pylori eradication.ResultsAmong 23 470 patients who received initial H. pylori treatment, 21 285 (90.7%) were treated with amoxicillin-based regimens. The median age of the patients decreased from 2017 to 2020 (45.0 vs 39.0, p<0.0001). The main treatments were therapies containing amoxicillin and furazolidone, which had an eradication rate of 87.6% (14 707/16 784); those containing amoxicillin and clarithromycin had an eradication rate of 85.5% (3577/4182). The date of treatment, age, antibiotic regimen and duration of treatment showed correlations with the failure of H. pylori eradication in a multivariable logistic regression analysis. Finally, positive UBT results after eradication clustered around the cut-off value, in both the 13C-UBT and 14C-UBT.ConclusionsThe major H. pylori infection treatments for naïve patients were those containing amoxicillin and furazolidone, which offered the highest eradication rate. The date of treatment, age, antibiotic regimen and duration of treatment were risk factors for the failure of H. pylori eradication. Additionally, positive UBT results after eradication clustered around the cut-off value.

Efficacy of quadruple therapy with clarithromycin based on faecal molecular antimicrobial susceptibility tests as first-line treatment forHelicobacter pyloriinfection: a protocol of a single-centre, single-blind, randomised clinical trial in China

“…Amoxicillin-clarithromycin-containing bismuth-containing quadruple therapy (BQT) is one of the most useful regimens against H. pylori . 1 4–6 Though the eradication rate of amoxicillin-based and clarithromycin-based BQT is over 85% according to our previous study, 7 the resistance to clarithromycin has been increasing in recent years and is considered a major cause of the failure of clarithromycin-based therapy. 8 9 According to a systematic review and meta-analysis in 2017, the prevalence of resistance to clarithromycin has risen significantly over time in the Asia-Pacific region in the past two decades, and the clarithromycin-containing regimens should be avoided in countries where the prevalence of clarithromycin resistance is higher than 20%.…”

“…Though Federal Drug Agency warns that furazolidone may reduce fertility or injure unborn children, the International Agency for Research on Cancer classified furazolidone into group 3, that is, not carcinogenic in humans 25 26. No serious adverse events (AEs) were reported among the cases in our previous large-scale retrospective study containing 25 796 patients 7. Furazolidone-containing therapies with a high eradication rate should be re-evaluated in other countries.…”

“…Based on previous studies, we assume the eradication rate of each group as 85%, 90% and 95%, respectively 7 11 22 28–30. We calculated that at least 855 participants (285 patients per treatment group) were required for recruitment for a two-sided α value of 0.05 and power of 90%, with a rate of loss to follow-up of 20%.…”

“…2 3 Amoxicillin-clarithromycin-containing bismuth-containing quadruple therapy (BQT) is one of the most useful regimens against H. pylori. 1 4-6 Though the eradication rate of amoxicillin-based and clarithromycinbased BQT is over 85% according to our previous study, 7 the resistance to clarithromycin has been increasing in recent years and is considered a major cause of the failure of clarithromycin-based therapy. 8 9 According to a systematic review and meta-analysis in…”

“…25 26 No serious adverse events (AEs) were reported among the cases in our previous large-scale retrospective study containing 25 796 patients. 7 Furazolidone-containing therapies with a high eradication rate should be re-evaluated in other countries.…”