超越马斯特里赫特IV标准：幽门螺杆菌的标准经验性三联疗法在一个南欧国家是否仍然有用？

Beyond Maastricht IV: are standard empiric triple therapies for Helicobacter pylori still useful in a South-European country?

作者信息

Almeida Nuno, Donato Maria Manuel, Romãozinho José Manuel, Luxo Cristina, Cardoso Olga, Cipriano Maria Augusta, Marinho Carol, Fernandes Alexandra, Calhau Carlos, Sofia Carlos

机构信息

Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal.

Gastroenterology Centre, Faculty of Medicine, Coimbra University, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal.

出版信息

BMC Gastroenterol. 2015 Feb 15;15:23. doi: 10.1186/s12876-015-0245-y.

DOI:10.1186/s12876-015-0245-y

PMID:25886722

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4339300/

Abstract

BACKGROUND

Empiric triple treatments for Helicobacter pylori (H. pylori) are increasingly unsuccessful. We evaluated factors associated with failure of these treatments in the central region of Portugal.

METHODS

This single-center, prospective study included 154 patients with positive (13)C-urea breath test (UBT). Patients with no previous H. pylori treatments (Group A, n = 103) received pantoprazole 40 mg 2×/day, amoxicillin 1000 mg 12/12 h and clarithromycin (CLARI) 500 mg 12/12 h, for 14 days. Patients with previous failed treatments (Group B, n = 51) and no history of levofloxacin (LVX) consumption were prescribed pantoprazole 40 mg 2×/day, amoxicillin 1000 mg 12/12 h and LVX 250 mg 12/12 h, for 10 days. H. pylori eradication was assessed by UBT 6-10 weeks after treatment. Compliance and adverse events were assessed by verbal and written questionnaires. Risk factors for eradication failure were determined by multivariate analysis.

RESULTS

Intention-to-treat and per-protocol eradication rates were Group A: 68.9% (95% CI: 59.4-77.1%) and 68.8% (95% CI: 58.9-77.2%); Group B: 52.9% (95% CI: 39.5-66%) and 55.1% (95% CI: 41.3-68.2%), with 43.7% of Group A and 31.4% of Group B reporting adverse events. Main risk factors for failure were H. pylori resistance to CLARI and LVX in Groups A and B, respectively. Another independent risk factor in Group A was history of frequent infections (OR = 4.24; 95% CI 1.04-17.24). For patients with no H. pylori resistance to CLARI, a history of frequent infections (OR = 4.76; 95% CI 1.24-18.27) and active tobacco consumption (OR = 5.25; 95% CI 1.22-22.69) were also associated with eradication failure.

CONCLUSIONS

Empiric first and second-line triple treatments have unacceptable eradication rates in the central region of Portugal and cannot be used, according to Maastricht recommendations. Even for cases with no H. pylori resistance to the used antibiotics, results were unacceptable and, at least for CLARI, are influenced by history of frequent infections and tobacco consumption.

摘要

背景

幽门螺杆菌（H. pylori）的经验性三联疗法越来越难以取得成功。我们评估了葡萄牙中部地区这些治疗失败的相关因素。

方法

这项单中心前瞻性研究纳入了154例（13）C - 尿素呼气试验（UBT）呈阳性的患者。既往未接受过幽门螺杆菌治疗的患者（A组，n = 103）接受泮托拉唑40 mg，每日2次，阿莫西林1000 mg，每12小时1次，克拉霉素（CLARI）500 mg，每12小时1次，疗程14天。既往治疗失败的患者（B组，n = 51）且无左氧氟沙星（LVX）使用史，给予泮托拉唑40 mg，每日2次，阿莫西林1000 mg，每12小时1次，LVX 250 mg，每12小时1次，疗程10天。治疗后6 - 10周通过UBT评估幽门螺杆菌根除情况。通过口头和书面问卷评估依从性和不良事件。通过多变量分析确定根除失败的危险因素。

结果

意向性治疗和符合方案的根除率在A组分别为68.9%（95%CI：59.4 - 77.1%）和68.8%（95%CI：58.9 - 77.2%）；B组分别为52.9%（95%CI：39.5 - 66%）和55.1%（95%CI：41.3 - 68.2%），A组43.7%和B组31.4%报告有不良事件。失败的主要危险因素在A组和B组分别是幽门螺杆菌对CLARI和LVX耐药。A组的另一个独立危险因素是频繁感染史（OR = 4.24；95%CI 1.04 - 17.24）。对于对CLARI无幽门螺杆菌耐药的患者，频繁感染史（OR = 4.76；95%CI 1.24 - 18.27）和当前吸烟（OR = 5.25；95%CI 1.22 - 22.69）也与根除失败相关。