METHODS: In this open-label, randomized controlled trial, we recruited 243 naïve Helicobacter pylori-infected patients from September 1, 2018, to November 30, 2021. They were randomly allocated (1:1) to the HDDT group (rabeprazole 20 mg and amoxicillin 750 mg q.i.d for 14 days, n = 122) and the HT group (rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days, followed by rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days, n = 121). Twelve patients were absent during follow-up in the HDDT group and 4 in the HT group, resulting in 110 for the HDDT group and 117 for HT group in the per protocol (PP) study. The outcome was determined by urea breath tests 8 weeks later.
RESULTS: The eradication rates for the HDDT and HT groups were 77.0% (95% confidence interval [CI]: 68.5% to 84.1%) and 94.2% (95% CI: 88.4% to 97.6%) (P < 0.001) in intention-to-treat analysis; 85.5% (95% CI: 77.5% to 91.5%) and 97.4% [95% CI: 92.6% to 99.5%] (P = 0.001) in per protocol analysis. The adverse event rates were 7.3% in the HDDT group and 14.5% in the HT group (P = 0.081). The habit of coffee drinking was the dependent factor for eradication failure in the HDDT group (88.2% vs. 68.8%, P = 0.040), but had no influence in the HT group (97.9% versus 95.0%, P = 0.449) in the univariate analysis.
CONCLUSIONS: This study demonstrated that 14-day rabeprazole-containing HDDT did not achieve > 90% eradication rates for first-line H. pylori eradication as 14-day rabeprazole-containing HT did. HDDT is a potentially beneficial combination, which involves only two drugs with mild adverse effects; more precise studies are urged to find answers regarding these failures. This clinical trial was registered retrospectively on 28 November, 2021, as ClinicalTrials.gov identifier: NCT05152004.
方法:在此开放标签中,随机对照试验,我们从2018年9月1日至2021年11月30日招募了243例未感染幽门螺杆菌的患者.他们被随机分配(1:1)到HDDT组(雷贝拉唑20mg和阿莫西林750mgq.i.d,持续14天,n=122)和HT组(雷贝拉唑20mg和阿莫西林1gb.i.d.持续7天,其次是雷贝拉唑20毫克,阿莫西林1克,克拉霉素500mg和甲硝唑500mgb.i.d.持续7天,n=121)。HDDT组随访期间12例患者缺席,HT组4例,在符合方案(PP)研究中,HDDT组为110,HT组为117。8周后通过尿素呼气试验确定结果。
结果:在意向治疗分析中,HDDT和HT组的根除率为77.0%(95%置信区间[CI]:68.5%至84.1%)和94.2%(95%CI:88.4%至97.6%)(P<0.001);85.5%(95%CI:77.5%至91.5%)和99.7.4%[95%CI:92.6%]HDDT组和HT组的不良事件发生率分别为7.3%和14.5%(P=0.081)。饮用咖啡的习惯是HDDT组根除失败的依赖因素(88.2%vs.68.8%,P=0.040),但在HT组中没有影响(97.9%对95.0%,单变量分析中的P=0.449)。
结论:这项研究表明,14天含雷贝拉唑的HDDT一线根除幽门螺杆菌的根除率没有达到超过90%,14天含雷贝拉唑的HT的根除率。HDDT是一种潜在的有益组合,其中仅涉及两种具有轻度不良反应的药物;我们敦促进行更精确的研究以找到有关这些失败的答案。这项临床试验于11月28日进行了回顾性注册,2021年,作为ClinicalTrials.gov标识符:NCT05152004。