Hsu Ping-I, Tsai Feng-Woei, Kao Sung-Shuo, Hsu Wen-Hung, Cheng Jin-Shiung, Peng Nan-Jing, Tsai Kuo-Wang, Hu Huang-Ming, Wang Yao-Kuang, Chuah Seng-Kee, Chen Angela, Wu Deng-Chyang
Division of Gastroenterology and Hepatology, Department of Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.
Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Am J Gastroenterol. 2017 Sep;112(9):1374-1381. doi: 10.1038/ajg.2017.195. Epub 2017 Jul 18.
OBJECTIVES: Proton pump inhibitor (PPI)-amoxicillin-fluoroquinolone triple therapy is recommended as a second-line treatment of Helicobacter pylori infection in the Maastricht V/Florence Consensus Report. However, the eradication rate of this standard salvage treatment is suboptimal. The objective of this study is to compare the efficacy of esomeprazole-bismuth-tetracycline-levofloxacin therapy (TL quadruple therapy) and esomeprazole-amoxicillin-levofloxacin triple therapy (AL triple therapy) in rescue treatment for H. pylori infection. METHODS: Consecutive H. pylori-infected subjects after failure of first-line therapies were randomly allocated to receive either TL quadruple therapy (esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) or AL triple therapy (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) for 10 days. H. pylori status was assessed 6 weeks after the end of treatment. RESULTS: The study was stopped after an interim analysis. Of 50 patients in the TL quadruple therapy, 49 (98.0%) had successful eradication of H. pylori infection. Cure of H. pylori infection was achieved in 36 of 52 patients (69.2%) receiving AL triple therapy. Intention-to-treat analysis demonstrated that TL quadruple therapy achieved a markedly higher eradication rate than AL triple therapy (difference: 28.8%; 95% confidence interval: 15.7% to 41.9%; P<0.001). Per-protocol analysis yielded a similar result (97.8% vs. 68.6%; P<0.001). The two treatment groups exhibited comparable frequencies of overall adverse events (22.0% vs. 11.5%) and drug compliance (90.0% vs. 98.1%). The subgroup analysis showed that TL quadruple therapy was superior to AL triple therapy in patients with failure of either standard triple therapy (100% vs. 75.0%; P=0.010) or non-bismuth quadruple therapy (95.0% vs. 52.6%; P=0.003). CONCLUSIONS: Ten-day PPI-bismuth-tetracycline-levofloxacin quadruple therapy is a good option for rescue treatment of H. pylori infection following failure of standard triple or non-bismuth quadruple therapy.
目的：在《马斯特里赫特V/佛罗伦萨共识报告》中，质子泵抑制剂（PPI）-阿莫西林-氟喹诺酮三联疗法被推荐为幽门螺杆菌感染的二线治疗方案。然而，这种标准挽救治疗的根除率并不理想。本研究的目的是比较埃索美拉唑-铋剂-四环素-左氧氟沙星疗法（TL四联疗法）和埃索美拉唑-阿莫西林-左氧氟沙星三联疗法（AL三联疗法）在幽门螺杆菌感染挽救治疗中的疗效。 方法：一线治疗失败后的连续幽门螺杆菌感染患者被随机分配接受TL四联疗法（埃索美拉唑40mg，每日两次；铋剂120mg，每日四次；四环素500mg，每日四次；左氧氟沙星500mg，每日一次）或AL三联疗法（埃索美拉唑40mg，每日两次；阿莫西林500mg，每日四次；左氧氟沙星500mg，每日一次），疗程为10天。治疗结束6周后评估幽门螺杆菌感染情况。 结果：中期分析后研究提前终止。TL四联疗法组的50例患者中，49例（98.0%）成功根除幽门螺杆菌感染。接受AL三联疗法的52例患者中有36例（69.2%）实现幽门螺杆菌感染治愈。意向性分析表明，TL四联疗法的根除率显著高于AL三联疗法（差异：28.8%；95%置信区间：15.7%至41.9%；P<0.001）。符合方案分析得出了类似结果（97.8%对68.6%；P<0.001）。两个治疗组的总体不良事件发生率（22.0%对11.5%）和药物依从性（90.0%对98.1%）相当。亚组分析显示，在标准三联疗法失败（100%对75.0%；P=0.010）或非铋剂四联疗法失败（95.0%对52.6%；P=0.003）的患者中，TL四联疗法优于AL三联疗法。 结论：对于标准三联疗法或非铋剂四联疗法失败后的幽门螺杆菌感染挽救治疗，10天的PPI-铋剂-四环素-左氧氟沙星四联疗法是一个不错的选择。
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