[COMPARATIVE STUDY OF DE-NOL AND NOVOBISMOL IN REGIMENS ERADICATION IN PATIENTS WITH H. PYLORI--ASSOCIATED DISEASES].
OBJECTIVE
The aim of this study is to assess efficacy and safety of reinforced H. pylori eradication therapy.


METHODS
During 2013-2014, 40 outpatients were examined. The study included men and women 18-65 y.o. They have been devided in to 2 group by randomized choice (20 patients in each group). Patients were treated with the reinforced H. pylori eradication therapy: PPI (40 mg,/q12h), clarithromycin (500mg/q12h), amoxicillin (1000 mg/q12h), bismuth subcitrate (240 mg/q12h) for 10 days. The first group given bismuth subcitrate--De-Nol, the second group given Novobismol. Eradication was confirmed by a 13C-urea breath test and monoclonal stool antigen test 6-8 weeks after therapy.


RESULTS
A total of 34 patients underwent eradication treatment. Two were lost to follow-up (one patient in each group), four patients (two patients in each group) did not complete treatment due to adverse events. The eradication rates were 97.1% (95% CI, 88.9% -100.0%) by per-protocol (PP) and 82.5% (95% CI, 69.4% - 92.5%) by intention-to-treat (ITT) in the two groups. The ITT analyses resulted in rates of 85% (95% CI, 66.5-96.9) for the 10-d reinforced therapy with DeNol and was 80% (95% CI: 60.2-94.1) for the 10-d reinforced therapy with Novobismol (P = 0.68), while the PP analyses resulted in 100% (95% CI, 94.5-100.0) and 94.1% (95% CI: 78.3-99.9), respectively (P = 0.31).


CONCLUSIONS
The reinforced H. pylori eradication therapy (10-day high-dose PPI bismuth-containing standard triple therapy) achieves a significantly high eradication rates in patients with H. pylori - associated diseases. Both drugs (De- Nol and Novobismol) are both effective and safe for the first-line eradication of H. pylori.
V I
VI
Simanenkov
N V
NV
Zakharova
I V
IV
Savilova
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage*
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; C002791:bismuth tripotassium dicitrate