A large randomised controlled intervention trial to prevent gastric cancer by eradication of Helicobacter pylori in Linqu County, China: baseline results and factors affecting the eradication.

Autor: Pan KF; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China., Zhang L; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China., Gerhard M; Technische Universität München, Munich, Germany., Ma JL; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China., Liu WD; Healthy Bureau of Linqu County, Weifang, China., Ulm K; Technische Universität München, Munich, Germany., Wang JX; Healthy Bureau of Linqu County, Weifang, China., Zhang L; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China., Zhang Y; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China., Bajbouj M; Technische Universität München, Munich, Germany., Zhang LF; Healthy Bureau of Linqu County, Weifang, China., Li M; Healthy Bureau of Linqu County, Weifang, China., Vieth M; Institute of Pathology, Klinikum Bayreuth, Bayreuth, Germany., Liu RY; Healthy Bureau of Linqu County, Weifang, China., Quante M; Technische Universität München, Munich, Germany., Wang LH; Healthy Bureau of Linqu County, Weifang, China., Suchanek S; Department of Medicine, 1st Faculty of Medicine, Military University Hospital, Charles University, Prague, Czech Republic., Zhou T; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China., Guan WX; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China., Schmid R; Technische Universität München, Munich, Germany., Classen M; Technische Universität München, Munich, Germany International Digestive Cancer Alliance, Germany., You WC; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.
Jazyk: angličtina
Zdroj: Gut [Gut] 2016 Jan; Vol. 65 (1), pp. 9-18. Date of Electronic Publication: 2015 May 18.
DOI: 10.1136/gutjnl-2015-309197
Abstrakt: Objective: To clarify the full range of benefits and adverse consequences of Helicobacter pylori eradication as a strategy for gastric cancer prevention, the community-based intervention trial was launched in Linqu County, China.
Design: A total of 184,786 residents aged 25-54 years were enrolled in this trial and received (13)C-urea breath test. H. pylori positive participants were assigned into two groups, either receiving a 10-day quadruple anti-H. pylori treatment or lookalike placebos together with a single dosage of omeprazole and bismuth.
Results: The prevalence of H. pylori in trial participants was 57.6%. A total of 94,101 subjects completed the treatment. The overall H. pylori eradication rate was 72.9% in the active group. Gender, body mass index, history of stomach disease, baseline delta over baseline-value of (13)C-urea breath test, missed medication doses, smoking and drinking were independent predictors of eradication failure. The missed doses and high baseline delta over baseline-value were important contributors in men and women (all Ptrend<0.001). However, a dose-response relationship between failure rate and smoking or drinking index was found in men (all Ptrend<0.001), while high body mass index (Ptrend<0.001) and history of stomach disease were significant predictors in women. The treatment failure rate increased up to 48.8% (OR 2.87, 95% CI 2.24 to 3.68) in men and 39.4% (OR 2.67, 95% CI 1.61 to 4.42) in women with multiple factors combined.
Conclusions: This large community-based intervention trial to eradicate H. pylori is feasible and acceptable. The findings of this trial lead to a distinct evaluation of factors influencing eradication that should be generally considered for future eradication therapies.
Trial Registration Number: ChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements.
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Databáze: MEDLINE