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欧洲管理登记处(Hp-EuReg):5 年和 21533 例患者一线经验性根除处方的模式和趋势及其结果。

European Registry on management (Hp-EuReg): patterns and trends in first-line empirical eradication prescription and outcomes of 5 years and 21 533 patients.

机构信息

Gastroenterolgy Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBEREHD), Madrid, Spain.

Department of Pancreatic, Biliary and Upper Digestive Tract Disorders, AS Loginov Moscow Clinical Scientific Center, Moscow, Russian Federation.

出版信息

Gut. 2021 Jan;70(1):40-54. doi: 10.1136/gutjnl-2020-321372. Epub 2020 Sep 21.

Abstract

OBJECTIVE

The best approach for 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 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 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 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.

摘要

目的

最佳管理方法仍不明确。审核流程对于确保临床实践符合最佳护理标准至关重要。

设计

国际多中心前瞻性非干预性注册研究于 2013 年启动,旨在评估欧洲胃肠病学家在幽门螺杆菌感染管理方面的决策和结果。患者通过 AEG-REDCap 电子 CRF 进行注册。变量包括人口统计学、先前的根除尝试、规定的治疗、不良事件和结果。进行数据监测以确保数据质量。进行时间趋势和地理分析。

结果

对来自 27 个欧洲国家的 30394 例患者进行了评估,对 21533 例(78%)一线经验性幽门螺杆菌治疗进行了分析。预处理耐药率分别为克拉霉素 23%、甲硝唑 32%和两者均为 13%。阿莫西林和克拉霉素三联疗法最常被处方(39%),实现了 81.5%的改良意向治疗根除率。仅用 10 天铋四联或 14 天同时治疗可获得 90%以上的根除率。治疗时间延长、更高的酸抑制和更高的依从性与更高的根除率相关。时间趋势分析显示,处方存在地区依赖性变化,包括放弃三联疗法、使用更高的酸抑制和更长的治疗时间,这与总体疗效提高(84%-90%)相关。

结论

欧洲胃肠病学家对幽门螺杆菌感染的管理存在异质性、不理想和与当前建议不一致的情况。只有至少持续 10 天的四联疗法才能实现 90%以上的根除率。欧洲建议正在缓慢且异质性地纳入常规临床实践,这与相应的疗效提高相关。

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