克拉霉素与甲硝唑作为一线根除幽门螺杆菌治疗方案的比较：日本一项多中心、前瞻性、随机对照研究

Clarithromycin Versus Metronidazole as First-line Helicobacter pylori Eradication: A Multicenter, Prospective, Randomized Controlled Study in Japan.

作者信息

Nishizawa Toshihiro, Maekawa Takama, Watanabe Noriko, Harada Naohiko, Hosoda Yasuo, Yoshinaga Masahiro, Yoshio Toshiyuki, Ohta Hajime, Inoue Syuuji, Toyokawa Tatsuya, Yamashita Haruhiro, Saito Hiroki, Kuwai Toshio, Katayama Shunsuke, Masuda Eiji, Miyabayashi Hideharu, Kimura Toshio, Nishizawa Yuko, Takahashi Masahiko, Suzuki Hidekazu

机构信息

*Division of Gastroenterology, National Hospital Organization, Tokyo Medical Center †Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine ∥∥∥Department of Pharmacy, National Center for Global Health and Medicine, Tokyo ‡Division of Gastroenterology, National Hospital Organization, Kyoto Medical Center, Kyoto §Division of Gastroenterology, National Hospital Organization, Mie Central Medical Center, Mie ∥Division of Gastroenterology, National Kyushu Medical Center, Fukuoka ¶Division of Gastroenterology, National Hospital Organization, Saitama National Hospital, Wako #Division of Gastroenterology, National Hospital Organization, Beppu Medical Center, Beppu **Division of Gastroenterology, National Hospital Organization, Osaka Medical Center †††Division of Gastroenterology, National Hospital Organization, Osaka Minami Medical Center, Kawachinagano, Osaka ††Division of Gastroenterology, National Hospital Organization, Kanazawa Medical Center, Kanazawa, Ishikawa §§Division of Gastroenterology, National Hospital Organization, Fukuyama Medical Center ##Division of Gastroenterology, National Hospital Organization, Kure Medical Center, Hiroshima ∥∥Division of Gastroenterology, National Hospital Organization, Okayama Medical Center, Okayama ¶¶Division of Gastroenterology, National Hospital Organization, Asahikawa Medical Center, Asahikawa §§§Division of Gastroenterology, National Hospital Organization, Hokkaido Medical Center, Sapporo, Hokkaido ***Division of Gastroenterology, National Hospital Organization, Yonago Medical Center, Yonago, Tottori, Japan ‡‡Division of Gastroenterology, Kochi National Hospital, Kochi ‡‡‡Division of Gastroenterology, National Hospital Organization, Matsumoto Medical Center, Mesa, Matsumoto, Nagano.

出版信息

J Clin Gastroenterol. 2015 Jul;49(6):468-71. doi: 10.1097/MCG.0000000000000165.

DOI:10.1097/MCG.0000000000000165

PMID:24921211

Abstract

BACKGROUND

Helicobacter pylori eradication rates achieved with a first-line regimen of clarithromycin (CLR) combined with amoxicillin (AMX) and a proton pump inhibitor have recently fallen to ≤80% because of the increasing incidence of CLR resistance in Japan. This randomized multicenter trial aimed to compare the eradication success of 2 first-line triple therapy regimens: rabeprazole, amoxicillin, and clarithromycin (RAC) versus rabeprazole, amoxicillin, and metronidazole (RAM).

METHODS

A total of 124 consecutive patients infected with H. pylori were randomized into one of two 7-day therapeutic regimens: RAC (n=60) or RAM (n=64). Eradication was confirmed by the C-urea breath test. Adverse effects were also assessed.

RESULTS

Intention-to-treat and per protocol H. pylori eradication rates were 73.3%/77.2% in the RAC group and 90.6%/93.5% in the RAM group. The eradication rate of RAM therapy was significantly higher than that of RAC therapy. CLR, metronidazole, and AMX resistance was found in 36.2%, 2.1%, and 0% of patients, respectively. In addition, no relevant differences in adverse effects were observed.

CONCLUSIONS

Metronidazole-based therapy (RAM) was superior to standard CLR-based therapy (RAC) for first-line H. pylori eradication. This reflects the progressive increase in CLR resistance observed in Japan.

摘要