Ramas Mercedes, Donday Maria G, McNicholl Adrian G, Gisbert Javier P
Servicio Aparato Digestivo, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain; Universidad Autónoma de Madrid and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain.
Servicio Aparato Digestivo, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain; Universidad Autónoma de Madrid and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain.
Gastroenterol Hepatol. 2017 Dec;40(10):658-662. doi: 10.1016/j.gastrohep.2017.05.017. Epub 2017 Aug 3.
A progressive decrease in Helicobacter pylori eradication rates has been described over the years, driving the need for new antibiotic treatments.
To evaluate the efficacy and safety of the addition of rifaximin (Spiraxin) to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori.
Independent prospective clinical trial (EUDRACT no.: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first five patients enrolled to evaluate the safety of the treatment. H. pylori eradication was confirmed with the C-urea breath test at least four weeks after the end of treatment with rifaximin 400mg/8h, clarithromycin 500mg/12h, amoxicillin 1g/12h and omeprazole 20mg/12h for 10 days.
Forty patients were consecutively enrolled, 53% woman, mean age 44 years. Indication for eradication: 60% non-investigated dyspepsia, 38% functional dyspepsia and 2% gastric ulcer. Four patients did not attend the eradication confirmatory breath test. The eradication rate was 61% (95% CI: 45-77%) for the protocol and 55% (40-70%) for intention-to-treat. About 76% of the patients experienced adverse events (35% diarrhea, 14% nausea and 24% metallic taste), none of which was serious. The blood tests did not show significant alterations.
Acceptable H. pylori eradication rates are not achieved with rifaximin associated with standard triple therapy for 10 days.
多年来，幽门螺杆菌根除率呈逐渐下降趋势，这促使人们需要新的抗生素治疗方法。
评估在标准三联疗法（奥美拉唑、阿莫西林和克拉霉素）中添加利福昔明（思连康）根除幽门螺杆菌的疗效和安全性。
独立前瞻性临床试验（欧盟临床试验编号：2013 - 001080 - 23）。连续纳入40例成年幽门螺杆菌感染患者，有消化不良症状且未接受过根除治疗。对最初纳入的5例患者进行了全血细胞检查以评估治疗安全性。在接受利福昔明400mg/8小时、克拉霉素500mg/12小时、阿莫西林1g/12小时和奥美拉唑20mg/12小时治疗10天后，至少在治疗结束四周后通过C - 尿素呼气试验确认幽门螺杆菌根除情况。
连续纳入40例患者，女性占53%，平均年龄44岁。根除指征：60%为未作检查的消化不良，38%为功能性消化不良，2%为胃溃疡。4例患者未参加根除确认呼气试验。方案分析的根除率为61%（95%置信区间：45 - 77%），意向性分析的根除率为55%（40 - 70%）。约76%的患者出现不良事件（35%腹泻，14%恶心，24%金属味），均不严重。血液检查未显示明显异常。
利福昔明联合标准三联疗法治疗10天未达到可接受的幽门螺杆菌根除率。
