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One-week triple therapy using omeprazole, amoxycillin and clarithromycin for the eradication of Helicobacter pylori in patients with non-ulcer dyspepsia: influence of dosage of omeprazole and clarithromycin.

Abstract：

BACKGROUND:Triple therapy based upon omeprazole, amoxycillin and clarithromycin for 7 days is the reference treatment used in France for the eradication of Helicobacter pylori. However, optimal dosages of omeprazole and clarithromycin have not been determined. AIMS:To compare four eradication regimens using this treatment in patients with non-ulcer dyspepsia. METHODS:Two hundred and seventy-four patients with symptoms of dyspepsia, normal upper GI endoscopy and a positive urease test were included in the study. A 13C-urea breath test (UBT) was obtained before and 6 weeks after treatment. Patients were randomized to one of the following 7-day regimens: 20 mg omeprazole o.m. plus amoxycillin 1000 mg b.d. plus clarithromycin 250 mg b.d. (O20AC500) or 20 mg omeprazole o.m. plus amoxycillin 1000 mg b.d. plus clarithromycin 500 mg b.d. (O20AC1000) or 20 mg omeprazole b.d. plus amoxycillin 1000 mg b.d. plus clarithromycin 250 mg b.d. (O40AC500) or 20 mg omeprazole b.d. plus amoxycillin 1000 mg b.d. plus clarithromycin 500 mg b.d. (O40AC1000). Compliance was assessed by returned tablet counts. Eradication was defined as conversion from positive 13C-UBT at entry to negative 13C-UBT 6 weeks after cessation of therapy. RESULTS:Two hundred and fifty-eight patients were included in the intention-to-treat (ITT) analysis. From the least to the most effective regimen, eradication rates were: O20AC1000: 60.0% (95% CI: 47.6-72.4), O20AC500: 64.1% (52.3-75.8), O40AC1000: 64.2% (52.7-75.7), O40AC500: 74.6% (64.2-85.0) (N.S.). Overall compliance was good in 92% of patients. The most frequent adverse events were diarrhoea and taste impairment, occurring mainly in the high-dose clarithromycin groups. CONCLUSIONS:Eradication rates obtained in this study were lower than those expected on the basis of previously reported studies. This study supports the use of a double dose of omeprazole, although the difference between groups was non-significant, but provides no argument in favour of a high dose of clarithromycin.

journal_name

Aliment Pharmacol Ther

journal_title

Alimentary pharmacology & therapeutics

authors

Bigard MA,Delchier JC,Riachi G,Thibault P,Barthelemy P

doi

10.1046/j.1365-2036.1998.00315.x

subject

Has Abstract

pub_date

1998-04-01 00:00:00

pages

383-8

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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One-week triple therapy using omeprazole, amoxycillin and clarithromycin for the eradication of Helicobacter pylori in patients with non-ulcer dyspepsia: influence of dosage of omeprazole and clarithromycin.