Abstract：
BACKGROUND: The optimal duration of regimens for tailored therapy based on genotypic resistance for clarithromycin has yet to be established.
OBJECTIVE: 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.
METHODS: 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 13C-urea breath test assessed eradication rates. The primary outcome was eradication rates of each group.
RESULTS: 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).
CONCLUSIONS: 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.
OBJECTIVE: 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.
METHODS: 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 13C-urea breath test assessed eradication rates. The primary outcome was eradication rates of each group.
RESULTS: 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).
CONCLUSIONS: 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.
摘要：
背景：基于克拉霉素基因型耐药性的定制治疗方案的最佳持续时间尚未确定。
目的：这项研究是一项全国性的，多中心，随机试验比较经验疗法和基于基因型耐药性的定制疗法一线根除幽门螺杆菌。我们还比较了每组7天和14天方案的根除率。
方法：幽门螺杆菌感染患者首先随机接受经验性或特制治疗。每组患者进一步随机分为7天或14天方案。经验疗法包括三联疗法（TT）方案（泮托拉唑40mg，每日两次，阿莫西林1克，和克拉霉素500毫克），持续7或14天。量身定制的治疗包括在没有基因型抵抗的患者中7或14天的TT。基因型耐药的患者接受铋四联疗法（BQT）治疗（每天两次剂量的泮托拉唑40mg，三日剂量的甲硝唑500毫克，以及每日四次剂量的铋300毫克和四环素500毫克），持续7或14天。13C-尿素呼气试验评估根除率。主要结果是各组的根除率。
结果：共593例患者纳入研究。经验性治疗组的根除率为65.7%(201/306)，定制治疗组的根除率为81.9%(235/287)，用于意向治疗分析(p<0.001)。在符合方案的分析中，经验治疗组和定制组的根除率分别为70.3%(201/286)和85.5%(235/274)(p<0.001),分别。两组依从性无差异。与经验组相比，定制组的不良事件发生率更高（p<0.001）。
结论：我们的研究证实，在韩国，基于基因型耐药性的定制治疗比经验治疗更有效。然而,每组的7日和14日治疗方案无显著差异.需要未来的研究来确定经验和定制治疗方案的最佳治疗持续时间。
目的：这项研究是一项全国性的，多中心，随机试验比较经验疗法和基于基因型耐药性的定制疗法一线根除幽门螺杆菌。我们还比较了每组7天和14天方案的根除率。
方法：幽门螺杆菌感染患者首先随机接受经验性或特制治疗。每组患者进一步随机分为7天或14天方案。经验疗法包括三联疗法（TT）方案（泮托拉唑40mg，每日两次，阿莫西林1克，和克拉霉素500毫克），持续7或14天。量身定制的治疗包括在没有基因型抵抗的患者中7或14天的TT。基因型耐药的患者接受铋四联疗法（BQT）治疗（每天两次剂量的泮托拉唑40mg，三日剂量的甲硝唑500毫克，以及每日四次剂量的铋300毫克和四环素500毫克），持续7或14天。13C-尿素呼气试验评估根除率。主要结果是各组的根除率。
结果：共593例患者纳入研究。经验性治疗组的根除率为65.7%(201/306)，定制治疗组的根除率为81.9%(235/287)，用于意向治疗分析(p<0.001)。在符合方案的分析中，经验治疗组和定制组的根除率分别为70.3%(201/286)和85.5%(235/274)(p<0.001),分别。两组依从性无差异。与经验组相比，定制组的不良事件发生率更高（p<0.001）。
结论：我们的研究证实，在韩国，基于基因型耐药性的定制治疗比经验治疗更有效。然而,每组的7日和14日治疗方案无显著差异.需要未来的研究来确定经验和定制治疗方案的最佳治疗持续时间。
