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.

Background: The <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 b...

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Publicado en:BMC Gastroenterology Vol. 16; pp. 1 - 9
Autores principales: Ju Yup Lee, Nayoung Kim, Kyung Sik Park, Hyun Jin Kim, Seon Mee Park, Gwang Ho Baik, Ki-Nam Shim, Jung Hwan Oh, Suck Chei Choi, Sung Eun Kim, Won Hee Kim, Seon-Young Park, Gwang Ha Kim, Bong Eun Lee, Yunju Jo, Su Jin Hong, Lee, Ju Yup, Kim, Nayoung, Park, Kyung Sik, Kim, Hyun Jin
Formato: research tables/charts randomized controlled trial Journal Article
Publicado: BioMed Central 7/26/2016
Acceso en línea:Ver este registro en EBSCOhost
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      dt: 7/26/2016
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      pub: BioMed Central
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        NLM27460100
        117060409
        10.1186/s12876-016-0490-8
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        117060409
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        atl: 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.
      aug:
        au:
          Ju Yup Lee
          Nayoung Kim
          Kyung Sik Park
          Hyun Jin Kim
          Seon Mee Park
          Gwang Ho Baik
          Ki-Nam Shim
          Jung Hwan Oh
          Suck Chei Choi
          Sung Eun Kim
          Won Hee Kim
          Seon-Young Park
          Gwang Ha Kim
          Bong Eun Lee
          Yunju Jo
          Su Jin Hong
          Lee, Ju Yup
          Kim, Nayoung
          Park, Kyung Sik
          Kim, Hyun Jin
        affil: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea
      sug:
        subj:
          Antacids Therapeutic Use
          Antibiotics Therapeutic Use
          Helicobacter Pylori Drug Effects
          Bismuth Therapeutic Use
          Tetracycline Therapeutic Use
          Gastritis Drug Therapy
          Amoxicillin Therapeutic Use
          Helicobacter Infections Drug Therapy
          Male
          Treatment Failure
          Medication Compliance
          Tetracycline Adverse Effects
          Antibiotics Adverse Effects
          Human
          Antacids Adverse Effects
          Gastritis Microbiology
          Female
          Drug Administration Schedule
          Bismuth Adverse Effects
          Drug Therapy, Combination
          Helicobacter Infections Microbiology
          Amoxicillin Adverse Effects
          Drug Resistance, Microbial
          Middle Age
          Prospective Studies
          Validation Studies
          Comparative Studies
          Evaluation Research
          Multicenter Studies
          Randomized Controlled Trials
          Scales
          Middle Aged: 45-64 years
          Male
          Female
      ab: Background: The <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. Methods: In 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). (13)C-urea breath test, rapid urease testing, or histology was performed to check for eradication. Results: Intention-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). Conclusions: Ten-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 Registration: ClinicalTrials.gov ( NCT02159976 ); Registration date: 2014-06-03, CRIS ( KCT0001176 ); Registration date: 2014-07-23.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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