Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Preventive Healthcare Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
J Gastroenterol Hepatol. 2022 Oct;37(10):1911-1918. doi: 10.1111/jgh.15939. Epub 2022 Jul 19.
Potassium-competitive acid blockers (P-CABs) can be used to eradicate Helicobacter pylori infection. We aimed to evaluate the impact of treatment duration (7 vs 14 days) on successful H. pylori eradication with P-CAB-based triple therapy in Korea, where clarithromycin resistance rate is high.
We retrospectively reviewed the data of patients who received first-line treatment for H. pylori infection with tegoprazan-based triple therapy (50 mg tegoprazan + 1000 mg amoxicillin + 500 mg clarithromycin twice daily for 1 or 2 weeks). The primary endpoint was the eradication rate in intention-to-treat (ITT) analysis.
Of the 948 patients included in the study, 435 and 513 received 7-day and 14-day tegoprazan-based triple therapy, respectively. The eradication rate was higher in the 14-day therapy group than in the 7-day therapy group (ITT, 63.9%; 95% confidence interval [CI], 59.3-68.3%] vs 78.6% [95% CI, 74.9-81.9%], respectively, P < 0.001; per-protocol, 70.5% [95% CI, 65.8-74.8%] vs 85.1% [81.7-88.1%], respectively, P < 0.001). Overall adverse event rates did not differ between the two groups. Although six patients in the 14-day treatment group discontinued the prescribed medications due to adverse events, four of them (67%) discontinued the medication within 4 days.
The 14-day tegoprazan-based triple therapy showed a superior eradication rate and acceptable adverse events compared with the 7-day tegoprazan-based triple therapy. A 14-day treatment regimen may be required when H. pylori infection is treated with tegoprazan-based triple therapy in regions with high clarithromycin resistance.
钾离子竞争型酸阻断剂（P-CAB）可用于根除幽门螺杆菌感染。本研究旨在评估在韩国（克拉霉素耐药率较高），使用 P-CAB 三联疗法治疗时，疗程（7 天与 14 天）对根除幽门螺杆菌的影响。
我们回顾性分析了接受泰妥拉唑为基础的三联疗法（50mg 泰妥拉唑+1000mg 阿莫西林+500mg 克拉霉素，每日 2 次，疗程 1 或 2 周）一线治疗幽门螺杆菌感染患者的数据。主要终点为意向治疗（ITT）分析的根除率。
本研究共纳入 948 例患者，其中 435 例和 513 例分别接受 7 天和 14 天的泰妥拉唑为基础的三联疗法。14 天治疗组的根除率高于 7 天治疗组（ITT，63.9%[95%置信区间（CI）：59.3-68.3%] vs 78.6%[95%CI：74.9-81.9%]，P<0.001；符合方案分析，70.5%[95%CI：65.8-74.8%] vs 85.1%[81.7-88.1%]，P<0.001）。两组的总体不良事件发生率无差异。虽然 14 天治疗组有 6 例患者因不良事件停止服用规定药物，但其中 4 例（67%）在 4 天内停药。
与 7 天泰妥拉唑为基础的三联疗法相比，14 天泰妥拉唑为基础的三联疗法具有更高的根除率和可接受的不良事件。在克拉霉素耐药率较高的地区，使用泰妥拉唑为基础的三联疗法治疗幽门螺杆菌感染时，可能需要 14 天的治疗方案。
