Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China.
Laboratory of Translational Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China.
Helicobacter. 2024 Jul-Aug;29(4):e13121. doi: 10.1111/hel.13121.
Current guidelines recommend bismuth-containing quadruple therapy for patients newly diagnosed with Helicobacter pylori (H. pylori) infection. We aimed to compare the efficacy and safety of tetracycline administered three times daily versus four times daily in bismuth-containing quadruple therapy for first-line treatment of H. pylori infection.
This multicenter, noninferiority, randomized controlled study, conducted in China, recruited treatment-naïve adults with H. pylori infection, randomized 1:1 into two treatment groups to receive either of the following bismuth-containing quadruple therapies: esomeprazole 20 mg twice-daily; bismuth 220 mg twice-daily; amoxicillin 1000 mg twice-daily; and tetracycline 500 mg three times daily (TET-T) versus 500 mg four times daily (TET-F). At least 6 weeks post-treatment, a C-urea breath test was performed to evaluate H. pylori eradication.
In total, 406 patients were randomly assigned to the two treatment groups. Intention-to-treat eradication rates were 91.63% (186/203; 95% confidence interval [CI] 87.82%-95.44%) versus 90.15% (183/203; 95% CI 86.05%-94.25%) (p = 0.0005) and per-protocol eradication rates were 95.34% (184/193; 95% CI 92.36%-98.31%) versus 95.72% (179/187; 95% CI 92.82%-98.62%) (p = 0.0002) for the TET-T and TET-F group, respectively. TET-T-treated patients had a lower incidence of adverse effects than TET-F-treated patients (21.61% vs. 31.63%, p = 0.024), with no significant differences in compliance to treatment between the groups.
As a first-line therapy for H. pylori infection, the eradication rate of the TET-T therapy was noninferior to that of the TET-F therapy while significantly reducing the incidence of adverse reactions.
ClinicalTrials.gov identifier: NCT05431075.
目前的指南建议对新诊断出幽门螺杆菌（H. pylori）感染的患者使用含铋四联疗法。我们旨在比较每日三次和每日四次给予四环素在铋四联疗法作为 H. pylori 感染一线治疗中的疗效和安全性。
这是一项在中国进行的多中心、非劣效性、随机对照研究，纳入了未经治疗的 H. pylori 感染成年患者，按照 1:1 比例随机分为两组，分别接受以下两种含铋四联疗法之一治疗：埃索美拉唑 20mg，每日两次；铋 220mg，每日两次；阿莫西林 1000mg，每日两次；四环素 500mg，每日三次（TET-T）与 500mg，每日四次（TET-F）。治疗结束后至少 6 周，进行 C-尿素呼气试验以评估 H. pylori 根除情况。
共有 406 名患者被随机分配至两组。意向治疗根除率分别为 91.63%（186/203；95%置信区间 [CI] 87.82%-95.44%）和 90.15%（183/203；95% CI 86.05%-94.25%）（p=0.0005），按方案根除率分别为 95.34%（184/193；95% CI 92.36%-98.31%）和 95.72%（179/187；95% CI 92.82%-98.62%）（p=0.0002）。TET-T 治疗组不良反应发生率低于 TET-F 治疗组（21.61% vs. 31.63%，p=0.024），两组间治疗依从性无显著差异。
作为 H. pylori 感染的一线治疗方法，TET-T 疗法的根除率不劣于 TET-F 疗法，同时显著降低了不良反应发生率。
ClinicalTrials.gov 标识符：NCT05431075。
