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Triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication: A comparative three-armed randomized clinical trial

Seyed Amir Mirbagheri, Mehrdad Hasibi, Mehdi Abouzari, Armin Rashidi

            

   

Seyed Amir Mirbagheri, Department of Gastroenterology, Amir-Alam Hospital, Tehran, Iran

Mehrdad Hasibi, Department of Infectious Diseases, Amir-Alam Hospital, Tehran, Iran

Mehdi Abouzari, Armin Rashidi, Tehran University of Medical Sciences, Tehran, Iran

Correspondence to: Dr. Mehdi Abouzari, Tehran University of Medical Sciences, No.17, Alaei Alley, Ard-e-Iran Street, Shahr-e-Rey, Tehran, Iran. maboozari@yahoo.com

Telephone: +98-21-55931771  Fax: +98-21-55954828

Received: 2006-03-16             Accepted: 2006-04-21

 

Abstract

AIM: To compare the effectiveness of triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication in a comparative three-armed randomized clinical trial.

 

METHODS: A total of 360 H pylori-positive patients suffering from dyspepsia and aging 24-79 years with a median age of 42 years were enrolled in the study and randomly allocated into the following three groups: group A (n = 120) received a standard 1-wk triple therapy (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 500 mg clarithromycin b.i.d.); group B (n = 120) received a 10-d standard quadruple therapy (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 240 mg colloidal bismuth subcitrate b.i.d., and 500 mg metronidazole b.i.d.); group C (n = 120) received the new protocol, i.e. 375 mg sultamicillin (225 mg ampicillin plus 150 mg sulbactam) b.i.d. (before breakfast and dinner), instead of amoxicillin in the standard quadruple therapy for the same duration. Chi-square test with the consideration of P < 0.05 as significant was used to compare the eradication rates by intention-to-treat and per-protocol analyses in the three groups.

 

RESULTS: The per-protocol eradication rate was 91.81% (101 patients from a total of 110) in group A, 85.84% (97 patients from a total of 113) in group B, and 92.85% (104 patients from a total of 112) in group C. The intention-to-treat eradication rate was 84.17% in group A, 80.83% in group B, and 86.67% in group C. The new protocol yielded the highest eradication rates by both per-protocol and intention-to-treat analyses followed by the standard triple and quadruple regimens, respectively. However, the differences were not statistically significant between the three groups.

 

CONCLUSION: The results of this study provide further support for the equivalence of triple and quadruple therapies in terms of effectiveness, compliance and side-effect profile when administered as first-line treatment for H pylori infection. Moreover, the new protocol using ampicillin-sulbactam instead of amoxicillin in the quadruple regimen is a suitable first-line alternative to be used in regions with amoxicillin-resistant H pylori strains.

 

© 2006 The WJG Press. All rights reserved.

 

Key words: Triple therapy; Quadruple therapy; Ampicillin-sulbactam; H pylori

 

Mirbagheri SA, Hasibi M, Abouzari M, Rashidi A. Triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication: A comparative three-armed randomized clinical trial. World J Gastroenterol 2006; 12(30): 4888-4891

 

 http://www.wjgnet.com/1007-9327/12/4888.asp

 

INTRODUCTION

H pylori is responsible for the majority of peptic ulcer diseases and its eradication leads to the cure of such diseases, thereby eliminating the need for surgical treatment. Eradication of H pylori is indicated in the management of dyspepsia in patients under the age of 45 years without alarm symptoms (the ‘test and treat‘ strategy) and also serves as a preventive treatment in precursor lesions of gastric cancer.

    According to the Maastricht 2 guidelines, first-line eradication is triple therapy with the use of a proton-pump inhibitor b.i.d., 1 g amoxicillin b.i

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