PDF(Pubmed)
Abstract：
UNASSIGNED: Vonoprazan-based eradication therapies have a higher eradication rate than usual proton pump inhibitor (PPI)-based therapies in treating Helicobacter pylori infection. Should we use vonoprazan to treat patients who failed multiple eradication therapies? Because the drug is not available in most countries, we propose 2-dimension tailor-made therapy (2dTMT) without using vonoprazan.
UNASSIGNED: Patients who failed twice or more PPI-based triple therapies were recruited. Patients underwent CYP2C19 genotype and antibiotic susceptibility tests (ASTs). PPI doses per day were decided as per the CYP2C19 genotype: twice for poor and 4 times for extensive metabolizers (dimension 1). Two antibiotics were selected as per the results of the AST in each patient (dimension 2). Regimens of 2dTMT included 2 susceptible antibiotics and a PPI. For those who could not have enough information with the AST, tailor-made PPI dosing was indicated with empirically selected 2 antibiotics (one-dimension tailor-made therapy [1dTMT]).
UNASSIGNED: Of 51 candidates with multiple eradication failures, 37 patients underwent the genotype test and AST, and 24 succeeded to obtain sufficient information to select 2 susceptible antibiotics. Of them, 22 patients accepted to receive 14-day 2dTMT. Of the residual patients, 12 accepted to receive 14-day 1dTMT. The mean eradication rate of 2dTMT was 86.4% (95% confidence interval [CI]: 65.1%-98.8%) in intention-to-treat and 90.5% (95% CI: 69.6%-98.8%) in per-protocol analyses, whereas that of 1dTMT was 75.0% (95% CI: 42.8%-94.5%) in intention-to-treat and 90.0% (95% CI: 55.5%-99.7%) in per-protocol analyses.
UNASSIGNED: Without vonoprazan, 14-day 2dTMT could be one of the salvage therapies for patients with multiple eradication failures. In cases of insufficient information with the AST, 14-day 1dTMT could be an alternative therapy. Clinical Trials Registry number, UMIN000022154 (https://www.umin.ac.jp/icdr/index.html).
UNASSIGNED: Patients who failed twice or more PPI-based triple therapies were recruited. Patients underwent CYP2C19 genotype and antibiotic susceptibility tests (ASTs). PPI doses per day were decided as per the CYP2C19 genotype: twice for poor and 4 times for extensive metabolizers (dimension 1). Two antibiotics were selected as per the results of the AST in each patient (dimension 2). Regimens of 2dTMT included 2 susceptible antibiotics and a PPI. For those who could not have enough information with the AST, tailor-made PPI dosing was indicated with empirically selected 2 antibiotics (one-dimension tailor-made therapy [1dTMT]).
UNASSIGNED: Of 51 candidates with multiple eradication failures, 37 patients underwent the genotype test and AST, and 24 succeeded to obtain sufficient information to select 2 susceptible antibiotics. Of them, 22 patients accepted to receive 14-day 2dTMT. Of the residual patients, 12 accepted to receive 14-day 1dTMT. The mean eradication rate of 2dTMT was 86.4% (95% confidence interval [CI]: 65.1%-98.8%) in intention-to-treat and 90.5% (95% CI: 69.6%-98.8%) in per-protocol analyses, whereas that of 1dTMT was 75.0% (95% CI: 42.8%-94.5%) in intention-to-treat and 90.0% (95% CI: 55.5%-99.7%) in per-protocol analyses.
UNASSIGNED: Without vonoprazan, 14-day 2dTMT could be one of the salvage therapies for patients with multiple eradication failures. In cases of insufficient information with the AST, 14-day 1dTMT could be an alternative therapy. Clinical Trials Registry number, UMIN000022154 (https://www.umin.ac.jp/icdr/index.html).
摘要：
■在治疗幽门螺杆菌感染方面，基于沃诺拉赞的根除疗法比基于质子泵抑制剂（PPI）的常规疗法具有更高的根除率。我们应该使用vonoprazan治疗多次根除治疗失败的患者吗？因为该药物在大多数国家都没有，我们建议不使用vonoprazan的二维定制治疗（2dTMT）。
■招募两次或更多次基于PPI的三联疗法失败的患者。患者接受CYP2C19基因型和抗生素敏感性试验（AST）。根据CYP2C19基因型决定每天的PPI剂量：不良代谢者两次，广泛代谢者4次（维度1）。根据每个患者的AST结果选择两种抗生素(维度2)。2dTMT方案包括2种敏感抗生素和PPI。对于那些无法获得足够信息的人，根据经验选择的2种抗生素(一维定制治疗[1dTMT])表明了定制的PPI给药.
■在多次根除失败的51个候选人中，37例患者接受了基因型测试和AST，24成功获得了足够的信息来选择2种敏感抗生素。其中,22名患者接受14天2dTMT。残余病人中，12接受接受14天1dTMT。意向治疗中2dTMT的平均根除率为86.4%(95%置信区间[CI]:65.1%-98.8%)，符合方案分析中2dTMT的平均根除率为90.5%(95%CI:69.6%-98.8%)。而1dTMT在意向治疗分析中为75.0%(95%CI:42.8%-94.5%),在符合方案分析中为90.0%(95%CI:55.5%-99.7%).
■没有vonoprazan，14天2dTMT可能是多次根除失败患者的挽救疗法之一。在AST信息不足的情况下，14天1dTMT可能是一种替代疗法。临床试验登记号,UMIN000022154(https://www.乌明。AC.jp/icdr/index。html).
■招募两次或更多次基于PPI的三联疗法失败的患者。患者接受CYP2C19基因型和抗生素敏感性试验（AST）。根据CYP2C19基因型决定每天的PPI剂量：不良代谢者两次，广泛代谢者4次（维度1）。根据每个患者的AST结果选择两种抗生素(维度2)。2dTMT方案包括2种敏感抗生素和PPI。对于那些无法获得足够信息的人，根据经验选择的2种抗生素(一维定制治疗[1dTMT])表明了定制的PPI给药.
■在多次根除失败的51个候选人中，37例患者接受了基因型测试和AST，24成功获得了足够的信息来选择2种敏感抗生素。其中,22名患者接受14天2dTMT。残余病人中，12接受接受14天1dTMT。意向治疗中2dTMT的平均根除率为86.4%(95%置信区间[CI]:65.1%-98.8%)，符合方案分析中2dTMT的平均根除率为90.5%(95%CI:69.6%-98.8%)。而1dTMT在意向治疗分析中为75.0%(95%CI:42.8%-94.5%),在符合方案分析中为90.0%(95%CI:55.5%-99.7%).
■没有vonoprazan，14天2dTMT可能是多次根除失败患者的挽救疗法之一。在AST信息不足的情况下，14天1dTMT可能是一种替代疗法。临床试验登记号,UMIN000022154(https://www.乌明。AC.jp/icdr/index。html).
