Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand.
Division of Gastroenterology, Department of Medicine, University of Michigan, Ann Arbor, Michigan, USA.
J Gastroenterol Hepatol. 2018 Nov;33(11):1822-1828. doi: 10.1111/jgh.14292. Epub 2018 Jun 27.
Eradication rates of Helicobacter pylori following standard triple therapy are declining worldwide, but high-dose proton pump inhibitor-based triple therapy (HD-PPI-TT) and sequential therapy (ST) have demonstrated higher cure rates. We aimed to compare the efficacy and tolerability of HD-PPI-TT and ST in H. pylori-associated functional dyspepsia (FD).
One hundred and twenty H. pylori-associated functional dyspepsia patients were randomized to receive 10-day HD-PPI-TT (60 mg lansoprazole/500 mg clarithromycin/1 g amoxicillin, each administered twice daily for 10 days) or 10-day ST (30 mg lansoprazole/1 g amoxicillin, each administered twice daily for 5 days followed by 30 mg lansoprazole/500 mg clarithromycin/400 mg metronidazole, each administered twice daily for 5 days). H. pylori status was determined in post-treatment week 4 by C-urea breath test. Eradication and antibiotic resistance rates, dyspeptic symptoms, drug compliance, and adverse effects were compared.
Intention-to-treat eradication rates were similar in the ST and HD-PPI-TT groups (85% vs. 80%; P = 0.47). However, the eradication rate was significantly higher following ST compared with HD-PPI-TT in per protocol analysis (94.4% vs. 81.4%; P = 0.035). ST achieved higher cure rates than HD-PPI-TT in clarithromycin-resistant H. pylori strains (100% vs. 33.3%; P = 0.02). Treatment compliance was similar in the HD-PPI-TT and ST groups, although nausea and dizziness were more common in the ST group.
Sequential therapy achieved better H. pylori eradication than HD-PPI-TT in patients with FD. However, the eradication rate for ST fell from 94.4% in per protocol to 85% in intention-to-treat analysis. Adverse effects might result in poorer compliance and compromise actual ST efficacy (ClinicalTrials.gov: NCT01888237).
全球范围内，标准三联疗法根除幽门螺杆菌的根除率正在下降，但高剂量质子泵抑制剂三联疗法（HD-PPI-TT）和序贯疗法（ST）已显示出更高的治愈率。我们旨在比较 HD-PPI-TT 和 ST 在幽门螺杆菌相关功能性消化不良（FD）中的疗效和耐受性。
将 120 例幽门螺杆菌相关功能性消化不良患者随机分为接受 10 天 HD-PPI-TT（60mg 兰索拉唑/500mg 克拉霉素/1g 阿莫西林，每日两次，共 10 天）或 10 天 ST（30mg 兰索拉唑/1g 阿莫西林，每日两次，共 5 天，然后 30mg 兰索拉唑/500mg 克拉霉素/400mg 甲硝唑，每日两次，共 5 天）。治疗后第 4 周通过 C-尿素呼气试验确定 H. pylori 状态。比较根除率和抗生素耐药率、消化不良症状、药物依从性和不良反应。
意向治疗根除率在 ST 和 HD-PPI-TT 组之间相似（85% vs. 80%；P=0.47）。然而，在方案分析中，ST 的根除率明显高于 HD-PPI-TT（94.4% vs. 81.4%；P=0.035）。ST 在克拉霉素耐药的幽门螺杆菌菌株中获得了比 HD-PPI-TT 更高的治愈率（100% vs. 33.3%；P=0.02）。HD-PPI-TT 和 ST 组的治疗依从性相似，但 ST 组更常见恶心和头晕。
序贯疗法在 FD 患者中比 HD-PPI-TT 更能有效地根除幽门螺杆菌。然而，ST 的根除率从方案分析中的 94.4%降至意向治疗分析中的 85%。不良反应可能导致依从性较差，从而影响实际 ST 疗效（ClinicalTrials.gov：NCT01888237）。
