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拉呋替丁与雷贝拉唑在含阿莫西林和甲硝唑的 7 天二线三联疗法根除幽门螺杆菌的比较:一项初步研究。

Comparison of lafutidine and rabeprazole in 7-day second-line amoxicillin- and metronidazole-containing triple therapy for Helicobacter pylori: a pilot study.

机构信息

Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan.

出版信息

Helicobacter. 2012 Aug;17(4):277-81. doi: 10.1111/j.1523-5378.2012.00943.x. Epub 2012 Mar 20.

Abstract

BACKGROUND

Lafutidine is an H2-receptor antagonist with gastroprotective action through capsaicin-sensitive afferent neurons and relatively inexpensive compare to proton-pump inhibitors (PPIs). A 7-day course of PPIs-amoxicillin-metronidazole is recommended as standard second-line Helicobacter pylori therapy and is covered by national health insurance in Japan. The aim of this study was to determine the efficacy and safety of second-line eradication using the H2-receptor antagonist lafutidine as a substitute for a PPI.

MATERIALS AND METHODS

Fifty-two patients who failed in first-line eradication using PPI-amoxicillin-clarithromycin were randomly assigned to a 7-day course of rabeprazole at 10 mg b.i.d., amoxicillin at 750 mg b.i.d., and metronidazole at 250 mg b.i.d. (RPZ-AM) or a 7-day course of lafutidine at 10 mg t.i.d., amoxicillin at 750 mg b.i.d., and metronidazole at 250 mg b.i.d. (LFT-AM) as second-line therapy. Eradication was assessed by the (13) C urea breath test. A drug susceptibility test was performed before the second-line therapy.

RESULTS

Prior to second-line H. pylori eradication, the rate of resistance to clarithromycin was 86.5% and the rate of resistance to metronidazole was 3.8%. The eradication rates for both LFT-AM and RPZ-AM groups were 96% (95%CI = 88.6-100%). There were no severe adverse events in either group.

CONCLUSIONS

Lafutidine plus metronidazole-amoxicillin as second-line therapy provided a high eradication rate and safe treatment similar to a PPI-based regimen. Lafutidine-based eradication therapy is therefore considered to be a promising alternative and is also expected to reduce health care costs in H. pylori eradication.

摘要

背景

拉呋替丁是一种 H2 受体拮抗剂,通过辣椒素敏感传入神经元发挥胃保护作用,且与质子泵抑制剂 (PPIs) 相比价格相对便宜。在日本,推荐使用质子泵抑制剂(如雷贝拉唑)-阿莫西林-甲硝唑作为标准二线治疗方案,为期 7 天,且该方案已纳入国家医疗保险。本研究旨在确定二线治疗方案中使用 H2 受体拮抗剂拉呋替丁替代 PPI 的疗效和安全性。

材料与方法

52 例使用 PPI-阿莫西林-克拉霉素一线治疗失败的患者被随机分配至雷贝拉唑 10 mg 每日两次(bid)、阿莫西林 750 mg bid、甲硝唑 250 mg bid(RPZ-AM)组或拉呋替丁 10 mg tid、阿莫西林 750 mg bid、甲硝唑 250 mg bid(LFT-AM)组,接受为期 7 天的二线治疗。采用 13C 尿素呼气试验评估根除率。二线治疗前进行了药物敏感性试验。

结果

二线 H. pylori 根除前,克拉霉素耐药率为 86.5%,甲硝唑耐药率为 3.8%。LFT-AM 组和 RPZ-AM 组的根除率均为 96%(95%CI = 88.6-100%)。两组均无严重不良事件。

结论

拉呋替丁联合甲硝唑-阿莫西林作为二线治疗方案,根除率高,安全性与基于 PPI 的方案相当。因此,拉呋替丁为基础的根除治疗方案被认为是一种很有前途的替代方案,也有望降低 H. pylori 根除治疗的医疗成本。

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