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Randomized controlled trial: PPI-based triple therapy containing metronidazole versus clarithromycin as first-line treatment for Helicobacter pylori in adolescents and young adults in Japan
Authors:Katushiro Mabe  Masumi Okuda  Shogo Kikuchi  Kenji Amagai  Rie Yoshimura  Mototsugu Kato  Naoya Sakamoto  Masahiro Asaka
Affiliation:1. Department of Gastroenterology, National Hospital Organization Hakodate Hospital, Hakodate, Hokkaido, Japan;2. Division of Endoscopy, Hokkaido University Hospital, Sapporo, Hokkaido, Japan;3. Department of Pediatrics, Aichi Medical University School of Medicine, Nagakute, Aichi, Japan;4. Department of Public Health, Aichi Medical University School of Medicine, Nagakute, Aichi, Japan;5. Division of Gastroenterology and G.I. Oncology, Ibaraki Prefectural Central Hospital and Cancer Centre, Kasama, Ibaraki, Japan;6. Department of Gastroenterology, Specific Medical Treatment Corporate Foundation Group, Hakuaikai Wellness Tenjin Clinic, Fukuoka, Japan;g. Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan;h. Health Sciences University of Hokkaido, Tobetsu, Hokkaido, Japan
Abstract:

Background/Aims

Treating Helicobacter pylori infection in young people is effective for preventing gastric cancer. This study compares the efficacy of triple therapies in adolescents and young adults in Japan.

Methods

This multicenter, randomized trial was conducted between February 2012 and March 2015. Infected participants were stratified into adolescents (13–19 years) and young adults (20–39 years). They were randomly assigned to a clarithromycin based (PAC) or metronidazole based (PAM) triple therapy for 1 week.

Results

Overall, 137 and 169 participants received the PAC and PAM treatments, respectively. In adolescents, the H. pylori eradication rates were 60.5% and 63.4% for PAC, and 98.3% and 100% for PAM in the intention-to-treat (ITT) and per-protocol (PP) analyses, respectively. In young adults, the eradication rates were 67.0% and 66.7% for PAC, and 95.5% and 96.3% for PAM in ITT and PP analyses, respectively. The eradication rate of PAM was significantly higher than that of PAC in both strata. No severe adverse events were observed.

Conclusion

In Japan, PAM may be selected as a first-line treatment for young people with H. pylori if antibiotic susceptibility tests cannot be performed.
Keywords:Adolescents  Young adults  Triple therapy  Metronidazole  PPI
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