Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Helicobacter. 2024 Jul-Aug;29(4):e13126. doi: 10.1111/hel.13126.
The optimal duration of regimens for tailored therapy based on genotypic resistance for clarithromycin has yet to be established.
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 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 C-urea breath test assessed eradication rates. The primary outcome was eradication rates of each group.
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).
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.
基于基因型耐药的个体化治疗方案的最佳疗程尚未确定。
本研究是一项全国性、多中心、随机试验，旨在比较基于基因型耐药的个体化治疗与经验性治疗一线根除幽门螺杆菌的疗效。我们还比较了两组中 7 天和 14 天方案的根除率。
首先将 H. pylori 感染患者随机分为接受经验性或个体化治疗。每组患者进一步随机分为 7 天或 14 天方案。经验性治疗包括三联疗法（TT）方案（每日两次剂量泮托拉唑 40mg、阿莫西林 1g 和克拉霉素 500mg）7 或 14 天。无基因型耐药的患者采用 TT 治疗 7 或 14 天。基因型耐药的患者采用铋四联疗法（BQT）方案（每日两次剂量泮托拉唑 40mg、每日三次剂量甲硝唑 500mg 和每日四次剂量枸橼酸铋钾 300mg 和四环素 500mg）治疗 7 或 14 天。C-尿素呼气试验评估根除率。主要结局是每组的根除率。
共纳入 593 例患者。意向治疗分析中，经验性治疗组的根除率为 65.7%（201/306），个体化治疗组为 81.9%（235/287）（p<0.001）。在符合方案分析中，经验性治疗组和个体化治疗组的根除率分别为 70.3%（201/286）和 85.5%（235/274）（p<0.001）。两组的依从性无差异。个体化治疗组的不良反应发生率高于经验性治疗组（p<0.001）。
本研究证实，基于基因型耐药的个体化治疗在韩国对 H. pylori 根除的疗效优于经验性治疗。然而，两组中 7 天和 14 天方案之间未发现差异。需要进一步研究来确定经验性和个体化治疗方案的最佳疗程。
