Puig Ignasi, González-Santiago Jesús M, Molina-Infante Javier, Barrio Jesús, Herranz Maria Teresa, Algaba Alicia, Castro Manuel, Gisbert Javier P, Calvet Xavier
Digestive Diseases Unit, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain.
Universitat Internacional de Catalunya, Barcelona, Spain.
Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.13004. Epub 2017 Sep 4.
The efficacy of currently recommended third-line therapies for Helicobacter pylori is suboptimal, even that of culture-guided treatments. Resistance to multiple antibiotics is the major factor related to treatment failure. The aim of this study was to evaluate the effectiveness and safety of a 14-day therapy using high-dose of amoxicillin, metronidazole and esomeprazole.
Multicenter open-label study as a register in routine clinical practice in patients with two previous failures of eradication therapy. A triple therapy with esomeprazole 40 mg b.d., amoxicillin 1 g t.d.s and metronidazole 500 mg t.d.s for 2 weeks was administered as a third-line therapy after a first treatment including clarithromycin and a second treatment including a quinolone. Helicobacter pylori status was determined by either histology or C-UBT both before and after treatment.
A total of 68 patients were included in this study. An interim analysis showed that only three out of eight patients who had received metronidazole in previous eradication regimens were cured (37%, 95% CI 8-75); as a result, after this interim analysis only metronidazole-naïve patients were included. The ITT eradication rate in metronidazole-naive patients was 64% (95% CI 51-76). Adverse events occurred in 58% of patients, all of them mild-to-moderate. Two patients (3%) did not complete >90% of the treatment because of side effects. No severe adverse events occurred.
Cure rates of this 14-day schedule using high-dose esomeprazole, amoxicillin and metronidazole as a third-line eradication regimen were suboptimal, especially in patients who had received metronidazole in previous failed eradication regimens.
目前推荐的幽门螺杆菌三线治疗方案疗效欠佳，即使是培养指导下的治疗也是如此。对多种抗生素耐药是治疗失败的主要相关因素。本研究的目的是评估高剂量阿莫西林、甲硝唑和埃索美拉唑14天疗法的有效性和安全性。
一项多中心开放标签研究，作为既往根除治疗两次失败患者的常规临床实践登记。在包括克拉霉素的首次治疗和包括喹诺酮的第二次治疗后，给予埃索美拉唑40mg每日两次、阿莫西林1g每日三次和甲硝唑500mg每日三次的三联疗法作为三线治疗，持续2周。治疗前后通过组织学或碳-尿素呼气试验（C-UBT）确定幽门螺杆菌状态。
本研究共纳入68例患者。一项中期分析显示，在既往根除方案中接受过甲硝唑治疗的8例患者中，只有3例治愈（37%，95%CI 8-75）；因此，在该中期分析后，仅纳入未使用过甲硝唑的患者。未使用过甲硝唑患者的意向性分析（ITT）根除率为64%（95%CI 51-76）。58%的患者发生不良事件，均为轻至中度。两名患者（3%）因副作用未完成超过90%的治疗。未发生严重不良事件。
以高剂量埃索美拉唑、阿莫西林和甲硝唑作为三线根除方案的这一14天疗程治愈率欠佳，尤其是在既往根除治疗失败方案中接受过甲硝唑治疗的患者中。
