Document Detail


High eradication rate of Helicobacter pylori using a four-drug regimen in patients previously treated unsuccessfully.
MedLine Citation:
PMID:  9385479     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The objective of this study was to assess the efficacy of a new regimen in eradicating Helicobacter pylori (Hp) in patients with duodenal ulcer (DU) who were previously treated unsuccessfully with standard triple therapy (tripotassium dicitratobismuthate [TDB] 120 mg QID, metronidazole 500 mg TID, and tetracycline 500 mg QID) or proton-pump inhibitor (PPI) dual therapy (omeprazole 20 mg BID and amoxicillin 500 mg QID). The study included 133 consecutive patients aged 17 to 83 years with endoscopically diagnosed DU (diameter > or = 5 mm) in whom standard triple therapy or PPI dual therapy had failed to eradicate Hp. A rapid urease (CLO) test was performed on four biopsy specimens at study entry and at least 1 month after the end of treatment to confirm Hp colonization and eradication, respectively. Patients were considered to be Hp positive if any CLO test was positive within 2 hours, and Hp was considered to be eradicated if all CLO tests were still negative after 24 hours. In 31 randomly selected patients, Hp eradication was confirmed histologically as well. Patients were given omeprazole 60 mg/d (20 mg in the morning and 40 mg in the evening) plus amoxicillin 500 mg QID for 10 days and subsequently were given metronidazole 500 mg TID for 10 days plus TDB 120 mg QID for 6 weeks. One hundred and twenty-four patients were followed up; five (4%) withdrew because of side effects (protracted diarrhea, stomatitis, skin rashes). Per-protocol analysis showed Hp eradication in 113 of 119 patients (95%) and ulcer healing in 118 of 119 (99%). Intent-to-treat analysis showed an Hp eradication rate of 85% (113 of 133 patients) and an ulcer healing rate of 89% (118 of 133 patients). In per-therapy analysis, the Hp eradication rate was 91% (113 of 124 patients), and the ulcer healing rate was 95% (118 of 124 patients). Side effects were observed in 39 of 119 patients (33%) and were generally mild. The four-drug regimen used in this study, when given to patients previously treated unsuccessfully with standard triple therapy or PPI dual therapy, was highly effective in eradicating Hp and healing DUs and had no major side effects.
Authors:
M Tzivras; V Balatsos; S Souyioultzis; M Tsirantonaki; N Skandalis; A Archimandritis
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical therapeutics     Volume:  19     ISSN:  0149-2918     ISO Abbreviation:  Clin Ther     Publication Date:    1997 Sep-Oct
Date Detail:
Created Date:  1997-12-30     Completed Date:  1997-12-30     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7706726     Medline TA:  Clin Ther     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  906-12     Citation Subset:  IM    
Affiliation:
Department of Pathophysiology, National University of Athens School of Medicine, Laiko General Hospital, Greece.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Aged, 80 and over
Amoxicillin / adverse effects,  therapeutic use*
Anti-Bacterial Agents / adverse effects,  therapeutic use*
Anti-Ulcer Agents / adverse effects,  therapeutic use*
Diarrhea / chemically induced
Drug Therapy, Combination
Duodenal Ulcer / drug therapy*
Female
Helicobacter Infections / drug therapy*
Helicobacter pylori / drug effects*
Humans
Male
Metronidazole / adverse effects,  therapeutic use*
Middle Aged
Nausea / chemically induced
Omeprazole / adverse effects,  therapeutic use*
Organometallic Compounds / adverse effects,  therapeutic use*
Recurrence
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Anti-Ulcer Agents; 0/Organometallic Compounds; 26787-78-0/Amoxicillin; 443-48-1/Metronidazole; 57644-54-9/bismuth tripotassium dicitrate; 73590-58-6/Omeprazole

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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