Branquinho Diogo, Almeida Nuno Miguel Peres de, Gregório Carlos, Casela Adriano, Donato Maria Manuel, Tomé Luís
Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Portugal.
Gastroenterology Department, Centro Hospitalar e Universitário de Coimbra.
Rev Esp Enferm Dig. 2017 Jun;109(6):430-434. doi: 10.17235/reed.2017.4759/2016.
Helicobacter pylori eradication rates with standard triple therapy in many countries are clinically unacceptable. Fluoroquinolone resistance is increasing and jeopardizing second-line regimens. There is a growing need for an effective strategy in patients who failed previous therapies.
This is a single-center, non-randomized clinical study conducted in the central region of Portugal. Sixty-four patients were included with a positive 13C-urea breath test (UBT) or histology for H. pylori, and at least one failed eradication attempt. The patient cohort included 71.7% of females with a median of age of 52 (range 23-87). They were treated with a twelve-day regimen consisting of a proton-pump inhibitor (PPI) bid, amoxicillin at 1,000 mg 12/12 h and levofloxacin at 500 mg bid during the first seven days, followed by PPI bid, clarithromycin at 500 mg 12/12h and either tinidazole or metronidazole at 500 mg bid/tid for five days. Eradication was assessed by UBT. The local Ethics Committee approved this study.
Eradication therapy was prescribed due to dyspepsia (66.7%), peptic ulcer (10%) and thrombocytopenia (8.3%). The median number of failed therapies was one (range 1-4). The eradication rate was 64.6% according to an intention-to-treat analysis (95% CI: 53-77%), and 70% by the per-protocol analysis (95% CI: 58-82%). Age, smoking, indication for eradication, previous therapies and the use of a second-generation or full-dose PPI did not affect success rates.
Even though treatment with four antibiotics was used, this "reinforced" therapy achieved suboptimal results. This fact highlights the lack of effective H. pylori antimicrobials and suggests that second-line treatment in our region should be prescribed according to susceptibility testing.
在许多国家，标准三联疗法对幽门螺杆菌的根除率在临床上难以令人接受。氟喹诺酮耐药性不断增加，危及二线治疗方案。对于先前治疗失败的患者，越来越需要一种有效的策略。
这是一项在葡萄牙中部地区进行的单中心、非随机临床研究。纳入了64例13C尿素呼气试验（UBT）或幽门螺杆菌组织学检查呈阳性且至少有一次根除尝试失败的患者。患者队列中71.7%为女性，年龄中位数为52岁（范围23 - 87岁）。他们接受了为期12天的治疗方案，前7天每天两次服用质子泵抑制剂（PPI）、每12小时服用1000毫克阿莫西林和每天两次服用500毫克左氧氟沙星，随后5天每天两次服用PPI、每12小时服用500毫克克拉霉素以及每天两次/三次服用500毫克替硝唑或甲硝唑。通过UBT评估根除情况。当地伦理委员会批准了本研究。
根除治疗的开具原因包括消化不良（66.7%）、消化性溃疡（10%）和血小板减少症（8.3%）。治疗失败的中位数次数为1次（范围1 - 4次）。意向性分析的根除率为64.6%（95%可信区间：53 - 77%），符合方案分析的根除率为70%（95%可信区间：58 - 82%）。年龄、吸烟、根除指征、先前治疗以及使用第二代或全剂量PPI均不影响成功率。
尽管使用了四种抗生素进行治疗，但这种“强化”疗法取得的效果并不理想。这一事实凸显了缺乏有效的幽门螺杆菌抗菌药物，并表明该地区的二线治疗应根据药敏试验来开具。
