Helicobacter最新文献

Background

Vonoprazan, a potassium-competitive acid blocker, has demonstrated greater potency and a longer duration of acid suppression when compared to the proton pump inhibitors. However, data regarding the comparison between vonoprazan-based triple therapy with standard treatment for first-line Helicobacter pylori treatment are limited. This study aimed to compare the efficacy between 7-day vonoprazan-based triple therapy with high-dose amoxicillin (VAC-7) and 14-day extended sequential therapy (S-14).

Materials and Methods

This was a single-center prospective randomized controlled trial following a noninferiority design. Subjects over 20 years old with confirmed H. pylori infection were enrolled prospectively from Fu Jen Catholic University Hospital. They were randomly assigned to the VAC-7 or S-14 group. The primary endpoint was the eradication rate in first-line treatment, evaluated by urea breath test, with noninferiority determined using the Farrington–Manning method. The secondary outcome included adverse effect rates and compliance, assessed through self-administered questionnaires.

Results

Between December 2021 and June 2023, a total of 628 patients were recruited. The eradication rates by per-protocol analysis and intention-to-treat analysis were 88.6%/81.8% for VAC-7 and 90.3%/81.4% for S-14, respectively. The VAC-7 was non-inferior to S-14 in terms of ITT analysis. Subjects experienced fewer incidences of nausea, anorexia, dizziness, fatigue, and any severe adverse events in the VAC-7 group. Compliance was higher in the VAC-7 group, with 94% taking all the pills correctly.

Conclusions

Our findings supported the use of 7-day vonoprazan triple therapy with high-dose amoxicillin as the standard first-line treatment for H. pylori infection.

Trial Registration: ClinicalTrials.gov identifier: NCT05371249

Background

The situation of Helicobacter pylori eradication therapy has been changing over time, owing to increases in antimicrobial-resistant strains, lifestyle improvements, and changes in indications for eradication. In Japan, eradication therapy is now available to all H. pylori-positive patients under the medical insurance system, and the potassium-competitive acid blocker vonoprazan has been used for eradication from 2015. Recently, with the aging of society, opportunities to provide eradication to elderly patients are increasing, but the current status and effectiveness of eradication in elderly patients remains unclear. Therefore, we aimed to investigate the trends of H. pylori eradication in a metropolitan area to determine the factors associated with successful H. pylori eradication in elderly patients older than 80 years.

Methods

Trends in the eradication rates of patients who received first- or second-line eradication at 20 hospitals in the Tokyo metropolitan area from 2013 to 2023 were investigated.

Results

The eradication rates in the per-protocol analysis were 82.3% (95% confidence interval [CI]: 81.2%–83.2%) for the first-line treatment (n = 6481), and 87.9% (86.9%–88.9%) for the second-line treatment (n = 4899). Multivariate analysis showed that independent factors for successful eradication in the first-line treatment were an age of older than 80 years (OR: 0.606; 95% CI: 0.448–0.822), peptic ulcers (vs. atrophic gastritis: 3.817; 3.286–4.433), and vonoprazan (vs. proton pump inhibiters (PPIs), 3.817; 3.286–4.433), and an age of older than 80 years (0.503; 0.362–0.699) and vonoprazan (1.386; 1.153–1.667) in the second-line treatment.

Conclusion

After 2015, the eradication rate of both first- and second-line therapies were maintained at a higher level than before 2015, owing to the use of vonoprazan. As the H. pylori eradication rate in patients older than 80 years was low, an effective strategy for these patients needs to be developed in the future.

Background

The optimal duration of regimens for tailored therapy based on genotypic resistance for clarithromycin has yet to be established.

Aim

This study was a nationwide, multicenter, randomized trial comparing empirical therapy with tailored therapy based on genotypic resistance for first-line eradication of Helicobacter pylori. We also compared the eradication rates of 7- and 14-day regimens for each group.

Patients and Methods

Patients with H. pylori infection were first randomized to receive empirical or tailored therapy. Patients in each group were further randomized into 7- or 14-day regimens. Empirical therapy consisted of a triple therapy (TT) regimen (twice-daily doses of pantoprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg) for 7 or 14 days. Tailored therapy consisted of TT of 7 or 14 days in patients without genotypic resistance. Patients with genotypic resistance were treated with bismuth quadruple therapy (BQT) regimens (twice-daily doses of pantoprazole 40 mg, three daily doses of metronidazole 500 mg, and four times daily doses of bismuth 300 mg and tetracycline 500 mg) for 7 or 14 days. A ¹³C-urea breath test assessed eradication rates. The primary outcome was eradication rates of each group.

Results

A total of 593 patients were included in the study. The eradication rates were 65.7% (201/306) in the empirical therapy group and 81.9% (235/287) in the tailored therapy group for intention-to-treat analysis (p < 0.001). In the per-protocol analysis, the eradication rates of the empirical therapy and tailored groups were 70.3% (201/286) and 85.5% (235/274) (p < 0.001), respectively. There was no difference in compliance between the two groups. The rate of adverse events was higher in the tailored group compared to the empirical group (p < 0.001).

Discussion

Our study confirmed that tailored therapy based on genotypic resistance was more effective than empirical therapy for H. pylori eradication in Korea. However, no significant difference was found between 7- and 14-day regimens for each group. Future studies are needed to determine the optimal duration of therapy for empirical and tailored therapy regimens.

Background

Helicobacter pylori screening with eradication reduces gastric cancer (GC) development. However, it was unknown at what age the H. pylori screening should be implemented to achieve the greatest benefits at the least cost. This study aimed to determine the optimal age of H. pylori screening for primary GC prevention.

Materials and Methods

A state transition model for a hypothetical cohort of 15-year-olds from a healthcare payer perspective on a lifetime horizon was developed. Nine ages for H. pylori testing were considered: 15, 18, 20, 30, 40, 50, 60, 70, and 80 years. H. pylori screening was compared with no screening and annual, biennial, and triennial endoscopies starting at age 50. The main outcomes were costs, quality-adjusted life-years (QALYs), life expectancy life-years (LYs), incremental cost-effectiveness ratios, GC cases, stage I GC cases, and GC-related deaths. One-way, two-way, and probabilistic sensitivity analyses were performed to assess the uncertainty of the parameters.

Results

All H. pylori screenings at ages 15–80 were more cost-effective than all endoscopies and no screening. H. pylori screening at age 15 yielded the greatest cost-saving and benefits. The cost-effectiveness was sensitive to the adherence rate of H. pylori screening at age 15. Cost-effectiveness acceptability curves showed that H. pylori screening at age 15 was 99.6% cost-effective at a willingness-to-pay threshold of US$50,000 per QALY gained. Compared with no screening and biennial endoscopy in 15.6 million 15-year-olds from 2022 to 2037, respectively, H. pylori screening at age 15 saves US$9.70 million and US$2.39 billion, increases 1.26 million QALYs with 1312 LYs and 651 LYs, prevents 436 GC cases with 254 stage I GC cases and 305 stage I GC cases, and avoids 176 GC-related deaths and 72 GC-related deaths.

Conclusions

The optimal age for population-based H. pylori screening at ages 15–80 is the youngest, 15 years old. Shifting population-based H. pylori screening to younger people will reduce GC morbidity and mortality worldwide, along with a detailed investigation of the feasibility and long-term consequences of H. pylori eradication at a young age.

Background

Helicobacter pylori infection is a significant pathogen in gastrointestinal diseases. Previous studies have identified single-nucleotide polymorphisms (SNPs) are factors associated with H. pylori infection. Notably, Le^b and Sialyl-Le^x antigens, regulated by the FUT3 and FUT6 genes, play a crucial role in H. pylori infection. This study aimed to investigate the correlation between FUT3 and FUT6 gene polymorphisms and H. pylori infection in the Han population of northern China.

Materials and Methods

An immunoturbidimetric assay was employed to detect H. pylori infection, categorizing subjects into infected and noninfected groups. Gene variants were identified through sequencing. Finally, FUT3 and FUT6 gene polymorphisms were analyzed to assess their association with H. pylori infection.

Results

The frequency of the T allele (rs778805) and the G allele (rs61147939) in the infection group was significantly higher than that in the noninfection group (63.4% vs. 55.1%, p = 0.045; 55.2% vs. 47.0%, p = 0.042, respectively). In the infection group, the frequency of the AA genotype (rs3745635) in the recessive model, the TT genotype (rs778805) in the recessive model, and the GG genotype (rs61147939) in the recessive model were significantly higher than the noninfection group (5.8% vs. 2.3%, p = 0.042; 41.9% vs. 29.3%, p = 0.022; 34.9% vs. 20.5%, p = 0.0068, respectively). The frequency of the A13 haplotype and the A13/A13 diplotype of the FUT6 gene was significantly higher in the infection group than in the noninfection group (55.56% vs. 46.32%, p = 0.019; 34.94% vs. 20.30%, p = 0.045, respectively). The rs778805-rs17855739-rs28362459-rs3745635 combination was identified as the best interaction model (p < 0.05).

Conclusions

This study suggests that FUT3 and FUT6 gene polymorphisms are significantly associated with H. pylori infection in the Han Chinese from northern China.

Objective

There is an economic evaluation on the family-based Helicobacter pylori screen-and-treat strategy (FBHS) in China. This study aimed to compare the cost-effectiveness of the FBHS with the traditional H. pylori screen-and-treat strategy (TBHS).

Materials and Methods

A seven-state microsimulation model, including H. pylori infection and gastric cancer states, was constructed on the basis of the target family samples from 29 provinces in China. Taking a lifetime horizon from a healthcare system perspective, the long-term costs and health outcomes of the FBHS and TBHS screening strategies were simulated separately, and economic evaluations were performed. The model parameters were primarily derived from real-world data, published literature, and expert opinions. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed as cost/quality-adjusted life-year (QALY) gained. One-way sensitivity analysis, probabilistic sensitivity analysis, and scenario analysis were performed to assess the uncertainty of the results.

Results

The base-case analysis revealed that the average costs for FBHS and TBHS were 563.67 CNY and 574.08 CNY, respectively, with corresponding average QALYs of 14.83 and 14.79. The ICER for the comparison between the two strategies was −214.07, indicating that FBHS was an absolutely dominant strategy with better cost-effectiveness. The results of both one-way sensitivity analysis and probabilistic sensitivity analysis were robust. When taking into account the added benefit of the higher H. pylori eradication rate in FBHS, the average costs were further reduced, and the average QALYs were increased, solidifying its position as an unequivocally dominant strategy.

Conclusion

The FBHS is an absolutely dominant and cost-effective strategy that enables an optimized allocation of screening resources. Decision-makers should prioritize FBHS when developing H. pylori prevention and control strategies.