Current medical research and opinion · 2004
The efficacy, safety and tolerability of pantoprazole-based one-week triple therapy in H. pylori eradication and duodenal ulcer healing.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Sivri Bulent, Simsek Ilkay, Hulagu Saadettin, Kadayifci Abdurrahman, Tozun Nurdan, Akarsu Mesut, Uraz Suleyman, Savas M Cemil, Koruk Mehmet, Bozbas Aysun
Аннотация
OBJECTIVE: Recently, proton pump inhibitor (PPI)-based triple therapy has been recommended as a first line treatment in the eradication of Helicobacter pylori. The aim of this open, multicentre trial was to investigate the efficacy, safety, tolerability and the ulcer healing rate of a triple regimen consisting of pantoprazole 40 mg, clarithromycin 500 mg and amoxicillin 1000 mg twice daily for 7 days, in the eradication of H. pylori in patients with duodenal ulcer in Turkey.
RESEARCH DESIGN AND METHODS: H. pylori infection was assessed by histological examination and rapid urease test at baseline and 4 weeks after the completion of the therapy. Seventy-seven patients were enrolled, 5 were excluded due to various reasons and 72 completed the entire course of the trial.
RESULTS: H. pylori eradication was confirmed in 49 of these patients; the eradication rate was 68% by per-protocol analysis and 63.6% by intention-to-treat analysis. The ulcers were completely healed in 61 patients (85%) at the second endoscopic examination. Drug compliance was excellent (97.3%) and there were no serious adverse events.
CONCLUSION: Pantoprazole-based 1-week triple therapy was well tolerated and the ulcer healing rate was high (85%). Relatively low H. pylori eradication rates may be attributed to rising antibiotic resistance over recent years. A large scale, comparative study with other PPI-based regimens is warranted based on the results of this open study with the pantoprazole-based regimen.
RESEARCH DESIGN AND METHODS: H. pylori infection was assessed by histological examination and rapid urease test at baseline and 4 weeks after the completion of the therapy. Seventy-seven patients were enrolled, 5 were excluded due to various reasons and 72 completed the entire course of the trial.
RESULTS: H. pylori eradication was confirmed in 49 of these patients; the eradication rate was 68% by per-protocol analysis and 63.6% by intention-to-treat analysis. The ulcers were completely healed in 61 patients (85%) at the second endoscopic examination. Drug compliance was excellent (97.3%) and there were no serious adverse events.
CONCLUSION: Pantoprazole-based 1-week triple therapy was well tolerated and the ulcer healing rate was high (85%). Relatively low H. pylori eradication rates may be attributed to rising antibiotic resistance over recent years. A large scale, comparative study with other PPI-based regimens is warranted based on the results of this open study with the pantoprazole-based regimen.