Terapevticheskii arkhiv · 2026
[Efficacy and safety of H. pylori eradication therapy in real-world clinical practice: results of the «PAMIR» observational program].
СтатьяНаблюдательное исследованиеАннотация на английскомНазвание и аннотация: Перевод в очереди
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Alexeev N Y, Astaf'eva T O, Vishnevskaya V V, Donchenko N D, Zhuravleva V V, Kruglova P A, Kurbatova A A, Pakhomova V M, Ugay L G, Filipenkova I A, Shigapova I R, Lapina T L, Ivashkin V T
Аннотация
AIM: To evaluate the efficacy, safety and impact on gastrointestinal symptoms of Helicobacter pylori eradication therapy with a ready-to-use set of tablets and capsules [omeprazole 20 mg × 2, clarithromycin 500 mg × 2, amoxicillin 500 mg × 4] (Pylobact® AM) in duodenal ulcer patients within the framework of an observational program.
MATERIALS AND METHODS: 912 H. pylori-positive patients were included (404 men and 508 women, average age - 43.8 years (43.82±11.39; 18-64 years). Symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire; patients assessed treatment satisfaction, and physicians assessed treatment efficacy and tolerability using a five-point Likert scale. The efficacy of H. pylori eradication was assessed using the results of the 13C-urea breath test, H. pylori antigen stool test, or a rapid urea test with biopsies of the gastric body and antrum obtained during upper endoscopy. A total of 870 patients completed the observational program: 538 patients in the standard triple therapy group (PAM group) and 332 patients in the group enhanced with a bismuth preparation, rebamipide, and/or a probiotic (PAMplus group). A subgroup of patients received triple therapy with bismuth and the synbiotic complex of Floriose with probiotic strains Lactobacillus acidophilus La-14, Lactobacillus rhamnosus Lr-32, Bifidobacterium lactis Bl-04, inulin and B vitamins.
RESULTS: H. pylori eradication rates in the PAM, PAMplus, and PAM+Bi+F (ITT) groups were 90.6, 97.03, and 96.82%, respectively. Treatment significantly reduced GSRS abdominal pain scores. Physicians rated the treatment efficacy and tolerability as "very good" or "good" at the end of the program in 93.3% of patients. Patients rated 93.68% as completely or mostly satisfied with the treatment.
CONCLUSION: The effectiveness of H. pylori eradication with a ready-to-use set of capsules and tablets for standard triple therapy is ensured by high patient compliance. The combination of standard triple therapy with bismuth, probiotics, and/or rebamipide increases treatment efficacy.
MATERIALS AND METHODS: 912 H. pylori-positive patients were included (404 men and 508 women, average age - 43.8 years (43.82±11.39; 18-64 years). Symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire; patients assessed treatment satisfaction, and physicians assessed treatment efficacy and tolerability using a five-point Likert scale. The efficacy of H. pylori eradication was assessed using the results of the 13C-urea breath test, H. pylori antigen stool test, or a rapid urea test with biopsies of the gastric body and antrum obtained during upper endoscopy. A total of 870 patients completed the observational program: 538 patients in the standard triple therapy group (PAM group) and 332 patients in the group enhanced with a bismuth preparation, rebamipide, and/or a probiotic (PAMplus group). A subgroup of patients received triple therapy with bismuth and the synbiotic complex of Floriose with probiotic strains Lactobacillus acidophilus La-14, Lactobacillus rhamnosus Lr-32, Bifidobacterium lactis Bl-04, inulin and B vitamins.
RESULTS: H. pylori eradication rates in the PAM, PAMplus, and PAM+Bi+F (ITT) groups were 90.6, 97.03, and 96.82%, respectively. Treatment significantly reduced GSRS abdominal pain scores. Physicians rated the treatment efficacy and tolerability as "very good" or "good" at the end of the program in 93.3% of patients. Patients rated 93.68% as completely or mostly satisfied with the treatment.
CONCLUSION: The effectiveness of H. pylori eradication with a ready-to-use set of capsules and tablets for standard triple therapy is ensured by high patient compliance. The combination of standard triple therapy with bismuth, probiotics, and/or rebamipide increases treatment efficacy.