European Registry on Helicobacter pylori management (Hp--EuReg): patterns and trends in first-line empirical eradication prescription and outcomes of 5 years and 21 533 patients
European Registry on Helicobacter pylori management (Hp--EuReg): patterns and trends in first-line empirical eradication prescription and outcomes of 5 years and 21 533 patients
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DOI：
10.1136/gutjnl-2020-321372
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发表时间：
2021-01-01
期刊：
影响因子：
24.5
通讯作者：
Gisbert, Javier P.
中科院分区：
文献类型：
--
作者：
Nyssen, Olga P.;Bordin, Dmitry;Gisbert, Javier P.
目的幽门螺杆菌的最佳治疗方法尚不清楚。审核过程对于确保临床实践与最佳护理标准保持一致至关重要。Design International多中心前瞻性非干预性注册始于2013年，旨在评估欧洲胃肠病专家在H.Pylori管理方面的决策和结果。患者通过AEG-Redcapp在e-CRF中注册。变量包括人口统计学、以前的根除尝试、处方治疗、不良事件和结果。进行数据监测，确保数据质量。结果对来自27个欧洲国家的30394名患者进行了评估，纳入了21533例(78%)一线经验性幽门螺杆菌治疗。治疗前对克拉霉素、甲硝唑和甲硝唑的耐药率分别为23%、32%和13%。阿莫西林和克拉霉素三联疗法是最常见的处方(39%)，达到81.5%的改良意向治疗根治率。只有在10天、4次或14天的同时治疗，才能达到90%以上的根除。治疗时间越长，抑酸率越高，依从性越好，根治率越高。时间趋势分析显示，处方的变化依赖于地区，包括放弃三联疗法，使用更高的抑酸率和更长的治疗时间，这与总体有效率增加(84%-90%)相关。结论欧洲胃肠病医生对幽门螺杆菌感染的治疗是异质性的，次优的，与当前的建议不一致。只有持续至少10天的四联疗法才能达到90%以上的根治率。欧洲的建议正在缓慢而异类地纳入常规临床实践，这与相应的有效性增加有关。
Objective The best approach for Helicobacter pylori management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care.Design International multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in H. pylori management by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables included demographics, previous eradication attempts, prescribed treatment, adverse events and outcomes. Data monitoring was performed to ensure data quality. Time-trend and geographical analyses were performed.Results 30 394 patients from 27 European countries were evaluated and 21 533 (78%) first-line empirical H. pylori treatments were included for analysis. Pretreatment resistance rates were 23% to clarithromycin, 32% to metronidazole and 13% to both. Triple therapy with amoxicillin and clarithromycin was most commonly prescribed (39%), achieving 81.5% modified intention-to-treat eradication rate. Over 90% eradication was obtained only with 10-day bismuth quadruple or 14-day concomitant treatments. Longer treatment duration, higher acid inhibition and compliance were associated with higher eradication rates. Time-trend analysis showed a region-dependent shift in prescriptions including abandoning triple therapies, using higher acid-inhibition and longer treatments, which was associated with an overall effectiveness increase (84%-90%).Conclusion Management of H. pylori infection by European gastroenterologists is heterogeneous, suboptimal and discrepant with current recommendations. Only quadruple therapies lasting at least 10 days are able to achieve over 90% eradication rates. European recommendations are being slowly and heterogeneously incorporated into routine clinical practice, which was associated with a corresponding increase in effectiveness.