Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, and National Yang-Ming University, Taipei, Taiwan.
Cheng Shiu University, Kaohsiung, Taiwan.
Antimicrob Agents Chemother. 2017 Oct 24;61(11). doi: 10.1128/AAC.00140-17. Print 2017 Nov.
Hybrid therapy is a novel two-step treatment achieving a high eradication rate for infection. Currently, whether this new therapy achieves a higher eradication rate than bismuth quadruple therapy remains an unanswered question. The aim of this prospective, randomized comparative study was to investigate the efficacies of 14-day hybrid therapy and bismuth quadruple therapy in the treatment of infection. From July 2013 to June 2015, eligible -infected subjects were randomly assigned to receive either 14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole for 14 days) or 14-day hybrid therapy (a 7-day dual therapy with pantoprazole plus amoxicillin, followed by a 7-day quadruple therapy with pantoprazole plus amoxicillin, clarithromycin, and metronidazole). status was examined 6 weeks after the end of treatment. Three hundred thirty -infected participants were randomized to receive 14-day bismuth quadruple therapy ( = 164) or 14-day hybrid therapy ( = 166). The eradication rates by intention-to-treat analysis were similar: 93.9% versus 92.8%, respectively (95% confidence interval [CI], -4.3% to 5.4%; = 0.68). Per-protocol analysis yielded similar results (96.7% versus 94.9%, respectively; = 0.44). However, bismuth quadruple therapy had a higher frequency of adverse events than hybrid therapy (55.5% versus 15.7%, respectively; 95% CI, 30.4% to 49.2%; < 0.001). The two treatments exhibited comparable drug adherence (93.9% versus 97%, respectively). The resistance rates of antibiotics were: clarithromycin, 16.7% of patients; amoxicillin, 1.3%; metronidazole, 25%; and tetracycline, 0%. In the bismuth quadruple therapy group, the eradication rate of metronidazole-resistant strains was lower than that of metronidazole-susceptible strains (70.0% versus 96.4%, respectively; = 0.04). In the hybrid therapy group, no significant impact of clarithromycin or metronidazole resistance on eradication rates was identified. Both 14-day hybrid and bismuth quadruple therapies cure most patients with infection in populations with moderate antibiotic resistance. However, the 14-day hybrid therapy has fewer adverse effects than the bismuth quadruple therapy. (This study has been registered at ClinicalTrials.gov under identifier NCT02541864.).
标题：四联疗法与含铋剂的二联序贯疗法治疗幽门螺杆菌感染的比较：一项前瞻性、随机对照研究
摘要：背景： 序贯疗法是一种新的两步治疗方法，可实现较高的 感染根除率。目前，这种新疗法是否比铋四联疗法具有更高的根除率仍是一个悬而未决的问题。本前瞻性、随机对照研究旨在比较 14 天序贯疗法和铋四联疗法治疗 感染的疗效。
方法： 2013 年 7 月至 2015 年 6 月，符合条件的 感染患者被随机分为接受 14 天铋四联疗法（质子泵抑制剂泮托拉唑、柠檬酸铋钾、四环素和甲硝唑连用 14 天）或 14 天序贯疗法（第 1 周用泮托拉唑加阿莫西林进行 7 天的二联疗法，然后用泮托拉唑加阿莫西林、克拉霉素和甲硝唑进行 7 天的四联疗法）。治疗结束后 6 周检查 状态。
结果： 333 例 感染患者被随机分为接受 14 天铋四联疗法（n = 164）或 14 天序贯疗法（n = 166）。意向治疗分析的根除率相似：分别为 93.9%和 92.8%（95%置信区间[CI]，-4.3%至 5.4%； = 0.68）。按方案分析得到了相似的结果（分别为 96.7%和 94.9%； = 0.44）。然而，铋四联疗法的不良反应发生率高于序贯疗法（分别为 55.5%和 15.7%；95%CI，30.4%至 49.2%； < 0.001）。两种治疗方法的药物依从性相似（分别为 93.9%和 97%）。抗生素耐药率为：克拉霉素，16.7%的患者；阿莫西林，1.3%；甲硝唑，25%；四环素，0%。在铋四联疗法组中，甲硝唑耐药株的根除率低于甲硝唑敏感株（分别为 70.0%和 96.4%； = 0.04）。在序贯疗法组中，克拉霉素或甲硝唑耐药对根除率没有显著影响。
结论： 14 天序贯和铋四联疗法均可治愈大多数中度抗生素耐药人群中的 感染患者。然而，与铋四联疗法相比，14 天序贯疗法的不良反应更少。
