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Ranitidine bismuth citrate with clarithromycin versus omeprazole with amoxycillin in the cure of Helicobacter pylori infection.

Abstract：

AIM:To compare the efficacy of ranitidine bismuth citrate plus clarithromycin (RBC-C) vs. omeprazole plus amoxycillin (OME-AMO) in the cure of Helicobacter pylori infection. METHODS:In this double-blind, multicentre, parallel-group study 122 H. pylori-positive patients with active duodenal ulcer or gastritis, with confirmed history of duodenal ulcer, were randomized to treatment with ranitidine bismuth citrate 400 mg b.d. plus clarithromycin 500 mg b.d. or omeprazole 20 mg b.d. plus amoxycillin 1000 mg b.d. for 14 days, followed by 14 days of ranitidine bismuth citrate 400 mg b.d. or omeprazole 20 mg once daily, respectively, to facilitate ulcer healing. Endoscopy was carried out at the start of the study and 28 days after the end of treatment. At each endoscopy four biopsies were obtained from the antrum and four biopsies from the corpus, for rapid urease test, histology and culture. H. pylori infection was defined as a positive urease test, confirmed by histology or culture. Cure of H. pylori infection was defined as negative urease test, histology or culture from both sites. RESULTS:Per-protocol, all-patients-treated and intention-to-treat cure rates (95% confidence interval) were, respectively, 90% (81-89%), 90% (82-89%) and 84% (74-93%) for ranitidine bismuth citrate plus clarithromycin, and 39% (27-54%), 44% (31-57%) and 41% (29-53%) for omeprazole plus amoxycillin, P < 0.00001. Both regimens were well tolerated. Eight patients were lost to follow-up, for lack of efficacy (one patient), adverse events (three patients) or refusal of second endoscopy (four patients). CONCLUSION:Ranitidine bismuth citrate 400 mg b.d. with clarithromycin 500 mg b.d. is superior to omeprazole 20 mg b.d. with amoxycillin 1000 mg b.d. Ranitidine bismuth citrate with clarithromycin is the first dual therapy with high cure rates and good tolerance, and is easy to take. It may therefore prove a suitable first-line treatment in H. pylori infection.

journal_name

Aliment Pharmacol Ther

journal_title

Alimentary pharmacology & therapeutics

authors

Kolkman JJ,Tan TG,Oudkerk Pool M,Van Kleef WA,Geraedts AA,Timmerman RJ,Crobach LF,Nicolai JJ,Wolff AA,Van Der Laan J

doi

10.1046/j.1365-2036.1997.00254.x

subject

Has Abstract

pub_date

1997-12-01 00:00:00

pages

1123-9

issue

eissn

0269-2813

issn

1365-2036

journal_volume

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Ranitidine bismuth citrate with clarithromycin versus omeprazole with amoxycillin in the cure of Helicobacter pylori infection.