Levofloxacin-containing Triple and Sequential Therapy or Standard Sequential Therapy as the First Line Treatment for Helicobacter pylori Eradication in China
Levofloxacin-containing Triple and Sequential Therapy or Standard Sequential Therapy as the First Line Treatment for Helicobacter pylori Eradication in China
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DOI：
10.1111/j.1523-5378.2012.00993.x
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发表时间：
2012-12-01
期刊：
影响因子：
4.4
通讯作者：
Zhang, Guo-Xin
中科院分区：
文献类型：
--
作者：
Qian, Juan;Ye, Feng;Zhang, Guo-Xin
目的比较含左氧氟沙星的三联疗法、标准序贯疗法和含左氧氟沙星的序贯疗法作为根除幽门螺杆菌一线治疗的疗效和不良反应。方法345例初治H。幽门螺杆菌阳性患者随机接受含左氧氟沙星的7天三联疗法（Levo三联，即，埃索美拉唑，20 mg，每日2次，阿莫西林，1 g，每日2次，左氧氟沙星，500 mg，每日1次，共7天，n = 114），标准序贯治疗（SST-10，5天埃索美拉唑，20 mg，每日两次和阿莫西林，1 g，每日两次，随后5天埃索美拉唑，20 mg，每日两次，克拉霉素，500 mg，每日两次和替硝唑，500 mg，每日两次，持续5天，n = 115）或含左氧氟沙星的序贯疗法（Levo-ST-10，5天埃索美拉唑，20 mg，每日两次和阿莫西林，1 g，每日两次，持续5天，随后5天埃索美拉唑，20 mg，每日两次，左氧氟沙星，500 mg，每日一次和替硝唑，500 mg，每日两次，n = 116）。治疗结束后4周，通过13 C-尿素呼气试验确认根除。结果Levo三联、SST-10和Levo-ST-10的意向治疗（ITT）根除率分别为78.1%（95% CI：69.4，85.3%）、78.3%（95% CI：69.6，85.4%）和82.8%（95% CI：74.6，89.1%）（p = 0.599）。三种治疗的符合方案（PP）根除率分别为80.9%（95% CI：72.3，87.8%）、82.6%（95% CI：74.1，89.2%）和86.5%（95% CI：78.7，92.2%）（p = 0.513）。总体而言，3.8%的患者发生轻度至中度不良事件;三组的发生率分别为1.75%、4.35%和5.17%（p = 0.325）。结论标准序贯疗法和7天左氧氟沙星三联疗法在中国的疗效不能令人满意。只有含左氧氟沙星的序贯治疗达到了临界可接受的结果。在中国，没有一种测试方案可靠地达到90%或更高的治疗有效性。
Aims To compare the efficacy and the adverse effects of levofloxacin-containing triple therapy, standard sequential therapy, and levofloxacin-containing sequential therapy as first-line treatment for Helicobacter pylori eradication. Methods Three hundred and forty-five naive H. pylori-positive patients were randomized to receive levofloxacin-containing 7-day triple therapy (Levo triple, i.e., esomeprazole, 20 mg, twice daily, amoxicillin, 1 g, twice daily, and levofloxacin, 500 mg, once daily for 7 days, n = 114), standard sequential therapy (SST-10, 5-day esomeprazole, 20 mg, twice daily and amoxicillin, 1 g, twice daily followed by 5-day esomeprazole, 20 mg, twice daily, clarithromycin, 500 mg, twice daily and tinidazole, 500 mg, twice daily for 5 days, n = 115) or levofloxacin-containing sequential therapy (Levo-ST-10, 5-day esomeprazole, 20 mg, twice daily and amoxicillin, 1 g, twice daily for 5 days followed by 5-day esomeprazole, 20 mg, twice daily, levofloxacin, 500 mg, once daily and tinidazole, 500 mg, twice daily, n = 116). Eradication was confirmed by a 13C-urea breath test 4 weeks after completion of treatment. Results Intention to treat (ITT) eradication rates were 78.1% (95% CI: 69.4, 85.3%), 78.3% (95% CI: 69.6, 85.4%), and 82.8% (95% CI: 74.6, 89.1%) for Levo triple, SST-10, Levo-ST-10, respectively (p = .599). Per protocol (PP) eradication rates were 80.9% (95% CI: 72.3, 87.8%), 82.6% (95% CI: 74.1, 89.2%), and 86.5% (95% CI: 78.7, 92.2%), respectively, for the three therapies (p = .513). Overall, 3.8% experienced mild to moderate adverse events; the rates were 1.75, 4.35, and 5.17%, respectively, in the three groups (p = .325). Conclusions Standard sequential therapy and 7-day levofloxacin triple therapy produced unacceptably therapeutic efficacy in China. Only levofloxacin-containing sequential therapy achieved borderline acceptable result. None of the regimens tested reliably achieved 90% or greater therapeutic efficacy in China.