Rescue Therapy for Helicobacter pylori Eradication: A Randomized Non-Inferiority Trial of Amoxicillin or Tetracycline in Bismuth Quadruple Therapy
Rescue Therapy for Helicobacter pylori Eradication: A Randomized Non-Inferiority Trial of Amoxicillin or Tetracycline in Bismuth Quadruple Therapy
复制标题
根除幽门螺杆菌的挽救疗法：铋四联疗法中阿莫西林或四环素的随机非劣效性试验。
DOI：
10.1038/ajg.2016.443
复制
发表时间：
2016-12-01
影响因子：
9.8
通讯作者：
Lu, Hong
中科院分区：
文献类型：
--
作者：
Chen, Qi;Zhang, Wei;Lu, Hong
目的：比较含铋四联疗法联合四环素或阿莫西林抢救幽门螺杆菌的疗效和安全性。方法：该研究是一项根除幽门螺杆菌的非劣效性试验，至少有两次治疗失败。受试者随机接受为期14天的双药治疗：兰索拉唑30 mg，铋220 mg，甲硝唑400 mg，阿莫西林1 g，一次（阿莫西林组）或四环素500 mg，一次（四环素组）。采用琼脂稀释法评价药敏。主要终点是治疗后6周幽门螺杆菌根除。结果：共纳入312例受试者，失访13例；29国违反了议定书。意向治疗、按方案治疗和修改意向治疗根除率分别为（阿莫西林）88.5%（138/156,95%可信区间（CI） 83.4-93.5%）、93.7% （133/142,95% CI 89.7-97.7%）和92.6% （138/149,95% CI 88.4-96.8%）。四环素组为87.2% （136/156,95% CI 81.9 ~ 92.4%）、95.3% （122/128,95% CI 91.7 ~ 99.0%）和90.7% （136/150,95% CI 86.0 ~ 95.3%）。阿莫西林、四环素和甲硝唑耐药率分别为8.3、1.0和87.8%。证实非劣效性（P < 0.025）。甲硝唑耐药不影响两种治疗的疗效。服用阿莫西林的患者比服用四环素的患者依从性更高，中度和重度不良事件较少。结论：甲硝唑联合阿莫西林的新型含铋四联疗法可替代传统的含铋四联疗法治疗幽门螺杆菌，其根除效果相似，且安全性和依从性更佳。
OBJECTIVES: To compare the efficacy and safety of bismuth-containing quadruple therapy with tetracycline or amoxicillin for rescue treatment of Helicobacter pylori.METHODS: The study was a non-inferiority trial of H. pylori eradication with at least two previous treatment failures. Subjects were randomized to receive 14-day therapy with b.i.d. lansoprazole 30 mg and bismuth 220 mg, plus metronidazole 400 mg q.i.d and amoxicillin 1 g t.i.d (amoxicillin group) or tetracycline 500 mg q.i.d (tetracycline group). Antimicrobial susceptibility was assessed by the agar-dilution method. Primary outcome was H. pylori eradication at 6 weeks after treatment.RESULTS: In all, 312 subjects were randomized, 13 were lost to follow-up; 29 violated the protocol. The intention-to-treat, per-protocol, and modified intention-to-treat eradication rates were (amoxicillin) 88.5% (138/156, 95% confidence interval (CI) 83.4-93.5%), 93.7% (133/142, 95% CI 89.7-97.7%), and 92.6% (138/149, 95% CI 88.4-96.8%). With tetracycline, they were 87.2% (136/156, 95% CI 81.9-92.4%), 95.3% (122/128, 95% CI 91.7-99.0%), and 90.7% (136/150, 95% CI 86.0-95.3%). Amoxicillin-, tetracycline-, and metronidazole-resistant rates were 8.3, 1.0, and 87.8%, respectively. Non-inferiority was confirmed (P < 0.025). Metronidazole resistance did not affect the efficacy of either therapy. Compliance was greater and moderate and severe adverse events were less among those receiving amoxicillin than those receiving tetracycline.CONCLUSIONS: The novel bismuth-containing quadruple therapy with metronidazole and amoxicillin is an alternative to classical bismuth quadruple therapy for H. pylori rescue treatment as it provides similar eradication with superior safety and compliance.