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-naïve 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. ClinicalTrials.gov no: NCT02328131.

中文翻译：

---

铋与标准三联疗法的结合可根除90％以上的患者的幽门螺杆菌感染。

背景与目的由于标准三联疗法的根除率很低，因此有人建议添加铋盐用于一线根除幽门螺杆菌。我们使用来自大型多中心注册机构的数据，评估了铋和标准的含克拉霉素的三联疗法在根除幽门螺杆菌感染中的有效性和安全性。方法我们对欧洲幽门螺杆菌管理登记处的数据进行了中期分析，这是一项前瞻性试验，记录了自2013年以来来自欧洲27个国家/地区的感染患者的临床数据和结局。我们提取了1141例未接受过一线治疗的未接受过治疗的患者的数据用铋盐（240 mg）和质子泵抑制剂治疗（57％的患者接受esomeprazole，18％的患者接受奥美拉唑，11％的患者接受pantoprazole，14％的患者接受雷贝拉唑，阿莫西林（1 g）和克拉霉素（500 mg），均每天服用两次。结果治疗的意愿和按方案的根除率分别为88％和94％。在接受14天治疗的患者中，根除治疗的意愿增加到93％。不良事件发生在36％的患者中；这些事件中有76％为轻度，平均持续时间为6天。在多因素分析中，根除与治疗依从性（比值比[OR]为13.0），双剂量（相当于40 mg奥美拉唑）质子泵抑制剂（OR为4.7）以及治疗14天的持续时间（OR， 2.0）。结论在分析大型多中心注册表中的数据时，根据治疗分析的意图，我们发现将铋添加到克拉霉素和阿莫西林的14天标准三联疗法中，可以根除幽门螺杆菌感染，且治疗可接受，具有可接受的安全性和依从性，从而可以消除90％以上的幽门螺杆菌感染。ClinicalTrials.gov编号：NCT02328131。