Journal of Antimicrobial Chemotherapy, Vol 42, 75-82, Copyright © 1998 by The British Society for Antimicrobial Chemotherapy
C Blandizzi, T Malizia, G Gherardi, F Costa, S Marchi, C Marveggio, G Natale, S Senesi, M Bellini, G Maltinti, M Campa and MD Tacca
The gastric mucosal distribution of azithromycin, the prototype of a new
class of macrolide antibiotics named azalides, was studied in patients with
duodenal ulcer and Helicobacter pylori-related gastritis. The time course
of ulcer healing, H. pylori infection, and gastritis activity was also
evaluated. Twenty patients (median age 50 years) received the following
treatment for 1 month: three cycles of azithromycin (500 mg/day for 3
consecutive days) on days 1-3, 11-13 and 21-23 plus omeprazole (40 mg/day)
for 30 consecutive days. Endoscopic biopsy specimens of gastric mucosa and
blood samples were collected on days 0, 4, 7, 10, 20 and 30. An additional
follow-up endoscopy was carried out on day 60. H. pylori infection was
determined by both histology and rapid urease test. Azithromycin
concentrations in both plasma and gastric mucosa were measured by a
microbiological plate assay, using Micrococcus luteus NCTC 8440 as the
reference organism. Azithromycin concentrations in plasma ranged between
0.17 mg/L (95% CI: 0.08-0.26; n = 5) and 0.32 mg/L (95% CI: 0.21-0.43; n =
5) throughout the treatment period. In addition, azithromycin
concentrations in gastric mucosa were significantly higher than plasma
concentrations at all times examined and ranged from 18.5 mg/kg (95% CI:
15-20; n = 20) to 24.6 mg/kg (95% CI: 16.8-32.4; n = 5), Indicating that
the drug was highly retained in the target tissue. Accordingly, the ratio
of azithromycin mucosal level to plasma concentration varied between 77.9
(95% CI: 56.5-99.3; n = 5) and 112.7 (95% CI: 100.2-125.2; n = 5). At the
end of treatment (day 30) H. pylori was no longer detected in 16 of 20
patients (80%), and this finding was consistent with a marked decrease in
the grading of gastritis activity. At the follow-up endoscopy (day 60) the
infection was eradicated in only four patients (20%). These data indicate a
favourable distribution of azithromycin into gastric mucosa of patients
with H. pylori infection and suggest that this new macrolide antibiotic
represents a valuable option for treatment regimens against H. pylori.
However, the low eradication rate achieved with azithromycin plus
omeprazole is a source of concern and requires further investigation.
ORIGINAL ARTICLES
Gastric mucosal distribution and clinical efficacy of azithromycin in patients with Helicobacter pylori related gastritis
Dipartimento di Oncologia, Universita di Pisa, Italy.
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