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Combination of Bismuth and Standard Triple Therapy Eradicates Helicobacter Pylori Infection in More Than 90% of Patients.

Clinical Gastroenterology and Hepatology(2019)SCI 1区

- Gastroenterology Unit | Moscow Clin Sci Ctr | Hosp Gen Tomelloso | Digest Ukrainian Acad Med Sci | Hosp Valme | Northwestern State Med Univ St Petersburg | Reg Clin Hosp 3 | - Department of Gastroenterology. Hospital Donostia/Instituto Biodonostia. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd). Universidad del País Vasco (UPV/EHU). San Sebastián | Agencia Sanitaria Costa Sol | Gastroenterol Unit Gastrocentr | First Clin Med Ctr | SM Clin | Hosp Cabuenes | HM Sanchinarro | Far Eastern State Med Univ | Consorci Sanitari Terrassa | Hosp San Pedro Alcantara | Hosp Sierrallana | Rio Hortega Univ Hosp | Hosp Alto Guadalquivir | Clin Nuestra Senora Rosario | Hosp Barbastro | Med Univ | Hop Pellegrin | Trinity Coll Dublin | Hosp Univ La Princesa

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Abstract
BACKGROUND & AIMS: Due to the poor eradication rates of standard triple therapy, the addition of bismuth salts has been proposed for first-line eradication of Helicobacter pylori. We assessed the effectiveness and safety of the combination of bismuth and the standard, clarithromycin-containing triple therapy in eradication of H pylori infection, using data from a large multi-center registry. METHODS: We performed an interim analysis of data from the European Registry on H pylori Management, a prospective trial registering clinical data and outcomes from infected patients from 27 countries in Europe since 2013. We extracted data on 1141 treatment-naive patients who received first-line treatment with bismuth salts (240 mg) and a proton pump inhibitor (57% received esomeprazole, 18% received omeprazole, 11% received pantoprazole, and 14% received rabeprazole), amoxicillin (1 g), and clarithromycin (500 mg), all taken twice daily. RESULTS: Intention to treat and per-protocol rates of eradication were 88% and 94%, respectively. Intention to treat eradication increased to 93% in patients who received 14-day treatments. Adverse events occurred in 36% of patients; 76% of these events were mild, with a mean duration of 6 days. In multivariate analysis, eradication was associated with treatment compliance (odds ratio [OR], 13.0), a double dose (equivalent to 40 mg omeprazole) of proton pump inhibitor (OR, 4.7), and 14-day duration of treatment (OR, 2.0). CONCLUSIONS: In an analysis of data from a large multi-center registry, we found the addition of bismuth to 14-day standard triple therapy with clarithromycin and amoxicillin to eradicate H pylori infection in more than 90% of patients, based on intention to treat analysis, with an acceptable safety profile and level of adherence.
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PPI,Bacteria,Optimized Treatment,Antimicrobial,Hp-EuReg,Database
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要点】:研究发现在标准三联疗法(克拉霉素和氨苄西林)中加入铋剂能够使超过90%的患者根除幽门螺杆菌感染,具有良好的安全性和依从性。

方法】:通过在14天标准三联疗法中添加铋剂,研究了其对幽门螺杆菌感染的根除效果。

实验】:在多中心注册数据进行分析的基础上,实验结果显示了铋剂增强三联疗法的效果,具体数据来源于ClinicalTrials.gov注册号为NCT02328131的试验。