Background Bismuth quadruple therapies (BQTs) including bismuth, a proton pump inhibitor (PPI) and two antibiotics have been shown to be highly effective for treating Helicobacter pylori infection even in areas of high bacterial antibiotic resistance. Objective To describe the time trends of use, effectiveness and safety of BQT in Europe using the European Registry on Helicobacter pylori Management (Hp-EuReg). Design Patients registered in the Hp-EuReg from 2013 to 2021 who had received BQT were included. The regimens prescribed, the number of eradication attempts, effectiveness, adherence and safety were analysed. The effectiveness was assessed by modified intention to treat (mITT). Time-trend and multivariate analyses were performed to determine variables that predicted treatment success. Results Of the 49 690 patients included in the Hp-EuReg, 15 582 (31%) had received BQT. BQT use increased from 8.6% of all treatments in 2013 to 39% in 2021. Single-capsule BQT—containing bismuth, metronidazole and tetracycline—plus a PPI (single-capsule BQT, ScBQT) was the most frequent treatment mode (43%). Schemes that obtained an effectiveness above 90% were the 10-day ScBQT and 14-day BQT using tetracycline plus metronidazole, or amoxicillin plus either clarithromycin or metronidazole. Only ScBQT achieved above 90% cure rates in all the geographical areas studied. Using the ScBQT scheme, adherence, the use of standard or high-dose PPIs, 14-day prescriptions and the use of BQT as first-line treatment were significantly associated with higher mITT effectiveness. Conclusion The use of BQT increased notably in Europe over the study period. A 10-day ScBQT was the scheme that most consistently achieved optimal effectiveness. Trial registration number [NCT02328131][1]. All data relevant to the study are included in the article or uploaded as online supplemental information. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02328131&atom=%2Fgutjnl%2Fearly%2F2024%2F11%2F11%2Fgutjnl-2024-332804.atom

中文翻译：

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2013 年至 2021 年含铋四联疗法治疗幽门螺杆菌感染的使用、有效性和安全性的演变：欧洲幽门螺杆菌管理登记处 （Hp-EuReg） 的结果


背景 包括铋、质子泵抑制剂 （PPI） 和两种抗生素在内的铋四联疗法 （BQT） 已被证明对治疗幽门螺杆菌感染非常有效，即使在细菌抗生素耐药性高的地区也是如此。目的 使用欧洲幽门螺杆菌管理登记处 （Hp-EuReg） 描述 BQT 在欧洲的使用、有效性和安全性的时间趋势。设计 纳入 2013 年至 2021 年在 Hp-EuReg 注册并接受 BQT 的患者。分析了规定的方案、根除尝试的次数、有效性、依从性和安全性。通过改良意向治疗 （mITT） 评估有效性。进行时间趋势和多变量分析以确定预测治疗成功的变量。结果 在 Hp-EuReg 纳入的 49 690 例患者中，15 582 例 （31%） 接受了 BQT。BQT 的使用从 2013 年所有治疗的 8.6% 增加到 2021 年的 39%。单胶囊 BQT（含有铋、甲硝唑和四环素）加 PPI（单胶囊 BQT、ScBQT）是最常见的治疗模式 （43%）。获得超过 90% 有效性的计划是使用四环素加甲硝唑或阿莫西林加克拉霉素或甲硝唑的 10 天 ScBQT 和 14 天 BQT。只有 ScBQT 在研究的所有地理区域实现了 90% 以上的治愈率。使用 ScBQT 方案、依从性、使用标准或高剂量 PPI、14 天处方以及使用 BQT 作为一线治疗与较高的 mITT 有效性显著相关。结论 在研究期间，BQT 的使用在欧洲显着增加。为期 10 天的 ScBQT 是最一致地实现最佳效果的计划。试验注册号 [NCT02328131][1]。 与研究相关的所有数据都包含在文章中或作为在线补充信息上传。[1]： /lookup/external-ref？link_type=CLINTRIALGOV&access_num=NCT02328131&atom=%2Fgutjnl%2Fearly%2F2024%2F11%2Fgutjnl-2024-332804.原子