Efficacy and Safety of Vonoprazan-Amoxicillin Dual Regimen With Varying Dose and Duration for Helicobacter pylori Eradication: A Multicenter, Prospective, Randomized Study.

BACKGROUND & AIMS: Previous studies confirm vonoprazan-amoxicillin effectiveness for Helicobacter pylori. This study aims to investigate vonoprazan with varying amoxicillin dose and duration. METHODS: This multicenter, prospective, randomized controlled, noninferiority trial enrolled patients with treatment naive H pylori infection from 5 clinical centers. Eligible participants were randomly assigned to H-VA-10 (vonoprazan 20 mg twice a day (b.i.d.) + amoxicillin 750 mg 4 times a day, 10 days), L-VA-10 (vonoprazan 20 mg b.i.d. + amoxicillin 1000 mg b.i.d, 10 days), and H-VA-14 (vonoprazan 20 mg b.i.d + amoxicillin 750 mg 4 times a day, 14 days) in a 1:1:1 ratio. The eradication rate was assessed using the 13C-urea breath test at least 28 days after treatment. RESULTS: Of the 623 eligible patients, 516 patients were randomized. In both the intention-to-treat and per-protocol analyses, eradication rates were comparable between H-VA-10 and H-VA-14 groups (86.6% vs 89.5% and 90.9% vs 94.5%, P = .021 and .013 for noninferiority, respectively). However, eradication rates were significantly lower in the L-VA-10 group than the H-VA-14 group (79.7% vs 89.5% and 82.0% vs 94.5%, P = .488 and .759, respectively). Rates of study withdrawal, loss to follow-up, and adverse events were similar across study groups. CONCLUSIONS: H-VA-10 and H-VA-14 regimens provide satisfactory efficacy for H pylori infection, and the L-VA-10 regimen was inferior. CLINICALTRIALS: gov number: NCT05719831.

Combination of vonoprazan and amoxicillin as the first-line Helicobacter pylori eradication therapy: a multicenter, prospective, randomized, parallel-controlled study.

The eradication rate of Helicobacter pylori (H. pylori) decreased gradually. This study aimed to analyze the efficacy and safety of a 14-day combination of vonoprazan and amoxicillin as the first-line eradication therapy for H. pylori infection and compared them with those of the bismuth quadruple therapy. A prospective randomized clinical trial (RCT) was designed, involving patients with H. pylori infection in 6 institutions who did not receive any treatment yet. They were randomly assigned into the VA-dual group (vonoprazan 20 mg b.i.d + amoxicillin 750 mg q.i.d) or EACP-quadruple group (esomeprazole 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg + colloidal bismuth subcitrate 220 mg b.i.d) for 14 days in a ratio of 1:1. At least 28 days later, the eradication rate was detected by the 13C-urea breath test (UBT). A total of 562 patients from February 2022 to September 2022 were enrolled and 316 were random. In the ITT analysis, the eradication rates of H. pylori in the VA-dual group and EACP-quadruple group were 89.9% and 81.0%, respectively, p = 0.037. In the PP analysis were 97.9% and 90.8%, p = 0.009. The different eradication rate was 8.9% (95% CI 1.2-16.5%) and 7.2% (95% CI 1.8-12.4%) in ITT and PP analyses, both lower limit of the 95%CI was still higher than the prespecified margin. In addition, the incidence of adverse events in the VA-dual group was significantly lower than that in the EACP-quadruple group (19.0% vs. 43.0%, P < 0.001). The efficacy and safety of a 14-day combination therapy of vonoprazan and amoxicillin in eradicating H. pylori are superior to bismuth quadruple therapy, and this combination significantly reduces the use of antibiotics.

Plateletcrit: a sensitive biomarker for evaluating disease activity in Crohn's disease with low hs-CRP.

OBJECTIVE: This study aimed to investigate whether PLT indices could act as non-invasive biomarkers for active Crohn's disease (CD). METHODS: Altogether 130 CD patients and 130 age- and gender-matched healthy volunteers were retrospectively enrolled in the study. CD patients were further divided into patients with active disease (Crohn's disease activity index [CDAI] >150) and in remission. PLT indices including PLT count, mean platelet volume (MPV), platelet distribution width (PDW), platelet large cell ratio (P-LCR) and plateletcrit (PCT) were detected. High-sensitivity C-reactive protein (hs-CRP) and erythrocyte sedimentation rate (ESR) levels were also determined. RESULTS: In active CD, PLT and PCT levels were notably higher but P-LCR and PDW levels were lower than those in healthy controls and patients in remission. PLT, PDW, P-LCR and PCT were significantly correlated with CDAI (P < 0.05). The receiver operating characteristic (ROC) curve showed that with a cut-off value of 0.28%, PCT achieved a sensitivity of 67% and a specificity of 63% for detecting active CD, with the area under ROC curve (AUROC) of 0.67, which was inferior to hs-CRP and ESR. For patients with active disease who had hs-CRP levels lower than 10.0 mg/L, PCT turned out to be the best index for monitoring disease activity (sensitivity 71%, specificity 85%, AUROC 0.77, P = 0.02). CONCLUSION: PCT may act as a specific and sensitive biomarker for determining active CD, especially in patients with an hs-CRP level lower than 10.0 mg/L.

Decreased expression of the FOXO3a gene is associated with poor prognosis in primary gastric adenocarcinoma patients.

BACKGROUND: FOXO3a, a member of the forkhead class 'O' (FOXO) transcription factor family, controls a wide spectrum of biological processes, such as DNA damage repair, apoptosis, and cell cycle regulation. FOXO3a has been shown to be a tumor suppressor in various cancers. This study investigated the expression of FOXO3a in primary gastric adenocarcinomas and its prognostic value for primary gastric adenocarcinoma patients. METHODS: Real-time quantitative RT-PCR (qRT-PCR), western blotting, and immunohistochemical staining were used to detect FOXO3a expression in primary gastric cancerous surgical specimens and adjacent non-tumorous tissues. RESULTS: Our data showed that the expression of FOXO3a mRNA (p = 0.03) and protein (p = 0.019) was lower in cancerous tissues compared with their adjacent non-tumorous tissues. In addition, the chi-square test revealed that low FOXO3a expression was significantly correlated with larger tumor size (p = 0.007), poor histopathological classification (p = 0.029), depth of invasion (p = 0.049), local lymph node metastasis (p = 0.013), distant metastasis (p = 0.013) and AJCC staging (p<0.001). Kaplan-Meier survival analysis demonstrated that low expression of FOXO3a was significantly correlated with a poor prognosis for gastric cancer patients (p<0.001). The multivariate analysis showed that FOXO3a expression was an independent prognostic factor of the overall survival rate of patients with primary gastric adenocarcinoma. CONCLUSION: Our study suggested that decreased FOXO3a expression may play an important role in the progression of gastric cancer. FOXO3a could be a valuable prognostic marker as well as a potential molecular therapy target for gastric cancer patients.