Clarithromycin versus Gemifloxacin in Quadruple Therapeutic Regimens for Helicobacter Pylori Infection Eradication.

BACKGROUND Helicobacter pylori (H. pylori) infection is a major casual factor in any peptic diseases. Clarithromycin as one of the drugs recommended for the infection eradication regimen has shown different levels of resistance. The present study is comparing the effectiveness of clarithromycin- and...

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Publicado en:Middle East Journal of Digestive Diseases Vol. 9; no. 2; pp. 100 - 107
Autores principales: Mansour-Ghanaei, Fariborz, Pedarpour, Zahra, Shafaghi, Afshin, Joukar, Farahnaz
Formato: research tables/charts randomized controlled trial Journal Article
Publicado: Iranian Association of Gastroenterology & Hepatology Apr2017
Acceso en línea:Ver este registro en EBSCOhost
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      pub: Iranian Association of Gastroenterology & Hepatology
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        10.15171/mejdd.2017.58
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        atl: Clarithromycin versus Gemifloxacin in Quadruple Therapeutic Regimens for Helicobacter Pylori Infection Eradication.
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        au:
          Mansour-Ghanaei, Fariborz
          Pedarpour, Zahra
          Shafaghi, Afshin
          Joukar, Farahnaz
        affil: Professor, Gastrointestinal & Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran
      sug:
        subj:
          Clarithromycin Therapeutic Use
          Antiinfective Agents, Quinolone Therapeutic Use
          Helicobacter Infections Drug Therapy
          Human
          Prospective Studies
          Randomized Controlled Trials
          Random Assignment
          Bismuth Administration and Dosage
          Pantoprazole Sodium Administration and Dosage
          Amoxicillin Administration and Dosage
          Clarithromycin Administration and Dosage
          P-Value
          Surveys
          Middle Age
          Adult
          Confidence Intervals
          Urease
          Breath Tests
          Middle Aged: 45-64 years
          Adult: 19-44 years
      ab: BACKGROUND Helicobacter pylori (H. pylori) infection is a major casual factor in any peptic diseases. Clarithromycin as one of the drugs recommended for the infection eradication regimen has shown different levels of resistance. The present study is comparing the effectiveness of clarithromycin- and gemifloxacin - based quadruple regimens in H. pylori eradication. METHODS This was a prospective double blind randomized clinical trial on patients with clear indication of H. pylori eradication. The patients were randomly divided into two groups: "BPAC group" treated with bismuth subcitrate (240 mg), pantoprazole (20 mg), amoxicillin (1 gr), and clarithromycin (500 mg), all twice daily, and the "BPAG group" treated with bismuth subcitrate, pantoprazole, and amoxicillin with same doses as "BPAC group" and gemifloxacin (320 mg daily) all for 10 days. Three months after the end of therapy, 14C-Urea breath test was performed to confirm the eradication. All the patients were assessed for compliance and drug side effects. Based on per-protocol (PP) and intention-to-treat (ITT) methods, data were analyzed and a P value<0.05 was considered as statistically significant. This project has been registered in the Iranian registry of clinical trials (IRCT). RESULTS Three patients were excluded from the survey and finally, 179 patients (89 patients in BPAC group and 90 patients in BPAG group) including 71(39.66%) men with the mean age of 46.4±12.3 years completed the treatment period. The incidence of side effects between the two study groups did not differ significantly. The success rate of BPAC regimen eradication was remarkably greater than BPAG regimen (ITT analysis; 89% vs 77%, respectively; CI 95%: 1.072-5.507, P<0.015 and PP analysis; 91% vs 77.8% respectively; CI 95%: P<0.015). There was no significant relationship between the demographic features and the eradication results. CONCLUSION The results showed that gemifloxacin is not a good alternative for clarithromycin in H. pylori eradication regimens in our region.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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