Comparison of sequential therapy and amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori: a prospective, multi-center, randomized clinical trial

BMC Gastroenterology

Research Article

Hyun Jin Kim¹  Su Jin Hong²  Seon-Young Park³  Seon Mee Park⁴  Yunju Jo⁵  Ki-Nam Shim⁶  Gwang Ho Baik⁷  Kyung Sik Park⁸  Sung Eun Kim⁹  Gwang Ha Kim^1,10  Bong Eun Lee^1,10  Nayoung Kim^1,11  Ju Yup Lee^1,12  Suck Chei Choi^1,13  Jung Hwan Oh^1,14  Won Hee Kim^1,15 

[1] Department of Internal Medicine and Institute of Health Science, Gyeongsang National University School of Medicine, Jinju, Gyeongsangnam-do, South Korea;Department of Internal Medicine and Research Institute, Soonchunhyang University College of Medicine, Bucheon, South Korea;Department of Internal Medicine, Chonnam National University Medical School, Gwangju, South Korea;Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, South Korea;Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, South Korea;Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, South Korea;Department of Internal Medicine, Hallym University College of Medicine, Chuncheon Sacred Heart Hospital, Chuncheon, South Korea;Department of Internal Medicine, Keimyung University School of Medicine, Daegu, South Korea;Department of Internal Medicine, Kosin University College of Medicine, Busan, South Korea;Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea;Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea;Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea;Department of Internal Medicine, Keimyung University School of Medicine, Daegu, South Korea;Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, South Korea;Departments of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea;Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, South Korea;

关键词: Helicobacter pylori;    Eradication;    Amoxicillin;    Tetracycline;    Bismuth;    Quadruple;   

DOI  :  10.1186/s12876-016-0490-8

 received in 2015-12-22, accepted in 2016-07-14,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe <80 % Helicobacter pylori eradication rate with sequential therapy is unsatisfactory. Modified bismuth quadruple therapy, replacing metronidazole with amoxicillin, could be promising because H. pylori resistance to tetracycline or to amoxicillin is relatively low. A 14-day modified bismuth quadruple protocol as first-line H. pylori treatment was compared with 10-day sequential therapy.MethodsIn total, 390 H. pylori-infected subjects participated in the randomized clinical trial: 10-day sequential therapy (40 mg pantoprazole plus 1 g amoxicillin twice a day for 5 days, then 40 mg pantoprazole and 500 mg clarithromycin twice a day and 500 mg metronidazole three times a day for 5 days) or 14-day modified bismuth quadruple therapy (40 mg pantoprazole, 600 mg bismuth subcitrate, 1 g tetracycline, and 1 g amoxicillin, twice a day). 13C-urea breath test, rapid urease testing, or histology was performed to check for eradication.ResultsIntention-to-treat (ITT) eradication rates of 10-day sequential and 14-day quadruple therapy were 74.6 % and 68.7 %, respectively, and the per-protocol (PP) rates were 84.2 and 76.5 %, respectively. The eradication rate was higher in the sequential therapy group, but neither the ITT nor the PP analyses had a significant difference (P = 0.240 and P = 0.099, respectively). However, the adverse events were significantly lower in the modified bismuth quadruple therapy group than the sequential therapy group (36.9 vs. 47.7 %, P = 0.040).ConclusionsTen-day sequential therapy appears to be more effective despite frequent adverse events. However, both 10-day SQT and 14-day PBAT did not reach the excellent eradication rates that exceed 90 %. Additional trials are needed to identify a more satisfactory first-line eradication therapy.Trial registrationClinicalTrials.gov (NCT02159976); Registration date: 2014-06-03, CRIS (KCT0001176); Registration date: 2014-07-23.

【 授权许可】

CC BY   
© The Author(s). 2016