Efficacy of 10-day Sitafloxacin-Containing Third-Line Rescue Therapies for Helicobacter pylori Strains Containing the gyrA Mutation
Efficacy of 10-day Sitafloxacin-Containing Third-Line Rescue Therapies for Helicobacter pylori Strains Containing the gyrA Mutation
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DOI：
10.1111/hel.12286
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发表时间：
2016-08-01
期刊：
影响因子：
4.4
通讯作者：
Kanai, Takanori
中科院分区：
文献类型：
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作者：
Mori, Hideki;Suzuki, Hidekazu;Kanai, Takanori
背景和艾米含西他沙星根除幽门螺杆菌是一种很有前途的三线治疗方法，但目前还没有研究幽门螺杆菌gyrA突变状态与含西他沙星10天方案疗效的关系。在这里，我们评估了两种不同的含西他沙星10天抢救方案的疗效。治疗前测定西他沙星、阿莫西林、甲硝唑的最低抑菌浓度(MICs)和幽门螺杆菌的gyrA突变状态。患者随机接受为期10天的三联疗法，其中包含埃索美拉唑(20 mg，bi.d)、阿莫西林(500 mg，qid)和西他沙星(100 mg，bi.d)。(EAS方案)或埃索美拉唑(20毫克，每日2次)、甲硝唑(250毫克，每日2次)和西他沙星(100毫克，每日2次)(EMS方案)。通过[13C]尿素呼气试验或幽门螺杆菌粪便抗原试验评估根治率。结果所有GyrA突变阴性株患者(EAS组24例，EMS组16例)均成功根除，无论他们接受的是什么方案。在GyrA突变阳性菌株的患者中，EAS组和EMS组的根治率分别为70.3%(26/37)和66.7%(26/39)(P=0.81)。Logistic回归分析显示，西他沙星的MIC与gyrA突变状态密切相关，与两组的根除成功独立相关。本研究在Umin临床试验注册中心登记为UMIN000006483。结论无论Hp菌株的gyrA突变状态如何，EAS和EMS的根治率无显著差异。GyrA突变状态是预测含西他沙星抢救疗法成功根除的重要因素。
Background and AimSitafloxacin-containing Helicobacter pylori eradication therapy is a promising third-line therapeutic approach, but there is no previous studies between gyrA mutation status of H. pylori strains and the efficacy of 10-day sitafloxacin-containing regimens. Here, we assessed the efficacy of 2 different 10-day sitafloxacin-containing rescue regimens.MethodsPatients who failed first- and second-line eradication therapies were enrolled. The minimum inhibitory concentrations (MICs) of sitafloxacin, amoxicillin, and metronidazole and the gyrA mutation status of the H. pylori strains were determined before treatment. The patients were randomized to receive a 10-day triple therapy containing either esomeprazole (20 mg, b.i.d.), amoxicillin (500 mg, q.i.d.), and sitafloxacin (100 mg, b.i.d.) (EAS regimen) or esomeprazole (20 mg, b.i.d.), metronidazole (250 mg, b.i.d.), and sitafloxacin (100 mg, b.i.d.) (EMS regimen). Eradication rates were evaluated by the [13C] urea breath test or the H. pylori stool antigen test.ResultsAll patients with gyrA mutation-negative strains (24 in EAS and 16 in EMS) showed successful eradication, irrespective of the regimen they received. In patients with gyrA mutation-positive strains, we found eradication rates of 70.3% (26/37) and 66.7% (26/39) in the EAS and EMS groups in per-protocol population, respectively (p = .81). According to logistic regression analyses, the MICs of sitafloxacin, which were strongly associated with gyrA mutation status, were independently associated with successful eradication in both groups. This study was registered in the UMIN Clinical Trials Registry as UMIN000006483.ConclusionThere is no significant difference in the eradication rates between EAS and EMS, regardless of the gyrA mutation status of the H. pylori strains. GyrA mutation status was an important factor in predicting successful eradication with sitafloxacin-containing rescue therapies.