Abstract：
BACKGROUND: The influence of indications for Helicobacter pylori investigation on prescriptions and effectiveness is unknown. The aim of the study was to assess the impact of indications for H. pylori investigation on prescriptions, effectiveness, compliance, and tolerance.
METHODS: International, prospective, non-interventional registry of the management of H. pylori infection by European gastroenterologists (Hp-EuReg). Treatment-näive patients registered from 2013 to 2023 at e-CRF AEG-REDCap were analyzed. The effectiveness was assessed by modified intention-to-treat analysis.
RESULTS: Overall, 53,636 treatment-naïve cases from 34 countries were included. Most frequent indications were: dyspepsia with normal endoscopy (49%), non-investigated dyspepsia (20%), duodenal ulcer (11%), gastric ulcer (7.7%), and gastroesophageal reflux disease (GERD) (2.6%). Therapy effectiveness varied by indication: duodenal ulcer (91%), gastric ulcer (90%), preneoplastic lesions (90%), dyspepsia with normal endoscopy (89%), GERD (88%), and non-investigated dyspepsia (87%). Bismuth-metronidazole-tetracycline and clarithromycin-amoxicillin-bismuth quadruple therapies achieved 90% effectiveness in all indications except GERD. Concomitant clarithromycin-amoxicillin-tinidazole/metronidazole reached 90% cure rates except in patients with non-investigated dyspepsia; whereas sequential clarithromycin-amoxicillin-tinidazole/metronidazole proved optimal (≥90%) in patients with gastric ulcer only. Adverse events were higher in patients treated for dyspepsia with normal endoscopy and duodenal ulcer compared with the remaining indications (23% and 28%, p < 0.001). Therapeutic compliance was higher in patients with duodenal ulcer and preneoplastic lesions (98% and 99%, p < 0.001).
CONCLUSIONS: In Europe, patients with gastric or duodenal ulcers and preneoplastic lesions showed higher H. pylori treatment effectiveness. Bismuth and non-bismuth quadruple therapies achieved optimal results in almost all indications.
BACKGROUND: ClinicalTrials.gov identifier: NCT02328131.
METHODS: International, prospective, non-interventional registry of the management of H. pylori infection by European gastroenterologists (Hp-EuReg). Treatment-näive patients registered from 2013 to 2023 at e-CRF AEG-REDCap were analyzed. The effectiveness was assessed by modified intention-to-treat analysis.
RESULTS: Overall, 53,636 treatment-naïve cases from 34 countries were included. Most frequent indications were: dyspepsia with normal endoscopy (49%), non-investigated dyspepsia (20%), duodenal ulcer (11%), gastric ulcer (7.7%), and gastroesophageal reflux disease (GERD) (2.6%). Therapy effectiveness varied by indication: duodenal ulcer (91%), gastric ulcer (90%), preneoplastic lesions (90%), dyspepsia with normal endoscopy (89%), GERD (88%), and non-investigated dyspepsia (87%). Bismuth-metronidazole-tetracycline and clarithromycin-amoxicillin-bismuth quadruple therapies achieved 90% effectiveness in all indications except GERD. Concomitant clarithromycin-amoxicillin-tinidazole/metronidazole reached 90% cure rates except in patients with non-investigated dyspepsia; whereas sequential clarithromycin-amoxicillin-tinidazole/metronidazole proved optimal (≥90%) in patients with gastric ulcer only. Adverse events were higher in patients treated for dyspepsia with normal endoscopy and duodenal ulcer compared with the remaining indications (23% and 28%, p < 0.001). Therapeutic compliance was higher in patients with duodenal ulcer and preneoplastic lesions (98% and 99%, p < 0.001).
CONCLUSIONS: In Europe, patients with gastric or duodenal ulcers and preneoplastic lesions showed higher H. pylori treatment effectiveness. Bismuth and non-bismuth quadruple therapies achieved optimal results in almost all indications.
BACKGROUND: ClinicalTrials.gov identifier: NCT02328131.
摘要：
背景：幽门螺杆菌研究适应症对处方和有效性的影响尚不清楚。该研究的目的是评估幽门螺杆菌研究适应症对处方的影响，有效性,合规,和宽容。
方法：国际，prospective,欧洲胃肠病学家（Hp-EuReg）对幽门螺杆菌感染管理的非干预注册。分析了2013年至2023年在e-CRFAEG-REDCap注册的治疗患者。通过改良的意向治疗分析评估有效性。
结果：总体而言，包括来自34个国家的53,636例初治病例。最常见的适应症是：胃镜检查正常的消化不良（49％），未调查的消化不良（20％），十二指肠溃疡（11%），胃溃疡(7.7%)，胃食管反流病（GERD）（2.6%）。治疗效果因适应症而异：十二指肠溃疡（91％），胃溃疡（90%），肿瘤前病变（90％），胃镜检查正常的消化不良（89％），GERD（88%），和未调查的消化不良（87％）。除GERD外，铋-甲硝唑-四环素和克拉霉素-阿莫西林-铋四联疗法在所有适应症中均达到90％的有效性。除未经调查的消化不良患者外，合并克拉霉素-阿莫西林-替硝唑/甲硝唑的治愈率达到90％；而仅在胃溃疡患者中，克拉霉素-阿莫西林-替硝唑/甲硝唑序贯证明是最佳的（≥90％）。与其余适应症相比，内镜检查正常的消化不良和十二指肠溃疡患者的不良事件较高（23％和28％，p<0.001)。十二指肠溃疡和肿瘤前病变患者的治疗依从性更高（98％和99％，p<0.001)。
结论：在欧洲，患有胃或十二指肠溃疡和肿瘤前病变的患者表现出更高的幽门螺杆菌治疗效果.铋和非铋四联疗法在几乎所有适应症中均达到最佳效果。
背景：ClinicalTrials.gov标识符：NCT02328131。
方法：国际，prospective,欧洲胃肠病学家（Hp-EuReg）对幽门螺杆菌感染管理的非干预注册。分析了2013年至2023年在e-CRFAEG-REDCap注册的治疗患者。通过改良的意向治疗分析评估有效性。
结果：总体而言，包括来自34个国家的53,636例初治病例。最常见的适应症是：胃镜检查正常的消化不良（49％），未调查的消化不良（20％），十二指肠溃疡（11%），胃溃疡(7.7%)，胃食管反流病（GERD）（2.6%）。治疗效果因适应症而异：十二指肠溃疡（91％），胃溃疡（90%），肿瘤前病变（90％），胃镜检查正常的消化不良（89％），GERD（88%），和未调查的消化不良（87％）。除GERD外，铋-甲硝唑-四环素和克拉霉素-阿莫西林-铋四联疗法在所有适应症中均达到90％的有效性。除未经调查的消化不良患者外，合并克拉霉素-阿莫西林-替硝唑/甲硝唑的治愈率达到90％；而仅在胃溃疡患者中，克拉霉素-阿莫西林-替硝唑/甲硝唑序贯证明是最佳的（≥90％）。与其余适应症相比，内镜检查正常的消化不良和十二指肠溃疡患者的不良事件较高（23％和28％，p<0.001)。十二指肠溃疡和肿瘤前病变患者的治疗依从性更高（98％和99％，p<0.001)。
结论：在欧洲，患有胃或十二指肠溃疡和肿瘤前病变的患者表现出更高的幽门螺杆菌治疗效果.铋和非铋四联疗法在几乎所有适应症中均达到最佳效果。
背景：ClinicalTrials.gov标识符：NCT02328131。
