A 10-Day Levofloxacin-Based Therapy in Patients With Resistant Helicobacter pylori Infection: A Controlled Trial

A 10-Day Levofloxacin-Based Therapy in Patients With Resistant Helicobacter pylori Infection: A Controlled Trial
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DOI:
10.1016/s1542-3565(04)00458-6
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发表时间:
2004-11-01
影响因子:
12.6
通讯作者:
Savarino, Vincenzo
Savarino, Vincenzo
中科院分区:
医学1区
文献类型:
--
作者:
Bilardi, Claudio;Dulbecco, Pietro;Savarino, Vincenzo

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背景与目的:抗生素耐药性是抗幽门螺杆菌治疗中的一个主要问题。本研究旨在评估2种疗法在耐药幽门螺杆菌感染患者中的疗效。研究方法:对1个或多个根除方案失败的患者进行上消化道内镜检查,并采集2份胃窦和2份胃体活检标本进行组织学和培养。甲硝唑,克拉霉素,阿莫西林耐药测定E-试验。患者被随机分配至2种治疗组:一组给予泮托拉唑40 mg,阿莫西林1 g,左氧氟沙星250 mg,每日2次,共10 d;另一组第1周给予奥美拉唑20 mg,每日2次,第2周给予奥美拉唑20 mg,每日2次,四环素250 mg,每日4次,甲硝唑500 mg,每日2次,次枸橼酸铋240 mg,每日两次,持续第二周。治疗4周后通过C-13尿素呼气试验评价治疗成功率。结果:我们招募了44例左氧氟沙星为基础的方案和46例四联疗法。使用意向治疗(ITT)分析,前者在44例患者中有31例成功(70%; 95%置信区间:53-87),后者在46例患者中有17例成功(37%; 95%置信区间:23-47)(P < .001)。幽门螺杆菌对甲硝唑、克拉霉素和阿莫西林的耐药率分别为46%、12%和0%。在10%的病例中发现对甲硝唑和克拉霉素的耐药性。结论:含左氧氟沙星的三联疗法优于四联疗法。观察到的70%成功率表明,对于1个或多个根除方案失败的患者,应考虑使用10天的泮托拉唑、阿莫西林和左氧氟沙星。
Background & Aims: Antibiotic resistance is a major issue in anti-Helicobacter pylori treatment. This study was aimed at assessing the efficacy of 2 therapies in patients with resistant H pylori infection. Methods: Patients who had failed 1 or more eradication regimens underwent upper gastrointestinal endoscopy and 2 antral and 2 corpus biopsy specimens were taken for histology and culture. Metronidazole, clarithromycin, and amoxicillin resistance were determined by E-test. Patients were randomly assigned to 2 therapies: 1 group received pantoprazole 40 mg, amoxicillin 1 g, levofloxacin 250 mg, all twice daily for 10 days, and the other group was treated with omeprazole 20 mg twice daily for the first week and omeprazole 20 mg twice daily, tetracycline 250 mg 4 times daily, metronidazole 500 mg twice daily, and bismuth subcitrate 240 mg twice daily for the second week. Therapeutic success was evaluated by C-13 urea breath test after 4 weeks of treatment. Results: We enrolled 44 patients in the levofloxacin-based regimen and 46 patients in the quadruple therapy. The former was successful in 31 of 44 (70%; 95% confidence interval: 53-87) and the latter in 17 of 46 (37%; 95% confidence interval: 23-47) patients, using intention-to-treat (ITT) analysis (P < .001). The rates of H pylori resistance to metronidazole, clarithromycin, and amoxicillin were 46%, 12%, and 0%, respectively. Resistance to both metronidazole and clarithromycin was found in 10% of cases. Conclusions: Triple therapy containing levofloxacin was better than quadruple therapy. The 70% success rate observed indicates that 10 days of pantoprazole, amoxicillin, and levofloxacin should be considered in patients who had failed 1 or more eradication regimens.