Multi-center randomized controlled study to establish the standard third-line regimen for Helicobacter pylori eradication in Japan

作者：Murakami Kazunari^*; Furuta Takahisa; Ando Takashi; Nakajima Takeshi; Inui Yoshikatsu; Oshima Tadayuki; Tomita Toshihiko; Mabe Katsuhiro; Sasaki Makoto; Suganuma Takanori; Nomura Hideyuki; Satoh Kiichi; Hori Shinichiro; Inoue Syuuji; Tomokane Takeshi; Kudo Mineo; Inaba Tomoki; Take Susumu; Ohkusa Toshifumi; Yamamoto Shojiro; Mizuno Shigeaki; Kamoshida Toshiro; Amagai Kenji; Iwamoto Junichi; Miwa Jun; Kodama Masaaki; Okimoto Tadayoshi; Kato Mototsugu; Asaka Masahiro

来源：Journal of Gastroenterology, 2013, 48(10): 1128-1135.

DOI：10.1007/s00535-012-0731-8

• Helicobacter pylori eradication therapy
• Drug resistance
• Levofloxacin
• Sitafloxacin
• Lansoprazole

The present study sought to establish a standard third-line eradication regimen for Helicobacter pylori in Japan. %26lt;br%26gt;Subjects were 204 patients with H. pylori infection in whom the standard Japanese first- and second-line eradication therapies had proven unsuccessful. Patients were randomly assigned to one of the following third-line eradication therapy groups: (1) LA group: lansoprazole (LPZ) 30 mg 4 times a day (qid) + amoxicillin (AMPC) 500 mg qid for two weeks; (2) LAL group: LPZ 30 mg twice a day (bid) + AMPC 750 mg bid + levofloxacin (LVFX) 300 mg bid for one week; (3) LAS group: LPZ 30 mg bid + AMPC 750 mg bid + sitafloxacin (STFX) 100 mg bid for one week. Patients for whom these therapies failed underwent a crossover fourth-line eradication regimen. Drug sensitivity was also tested for AMPC, clarithromycin (CAM), MNZ, LVFX, and STFX. %26lt;br%26gt;Drug resistance rates prior to third-line eradication therapy were 86.4 % for CAM, 71.3 % for MNZ, 57.0 % for LVFX, 8.2 % for AMPC, and 7.7 % for STFX. Intention-to-treat analysis of third-line eradication therapy eradication rates showed a significantly higher rate in the LAS group (70.0 %) compared with the LA group (54.3 %; p %26lt; 0.05) and the LAL group (43.1 %; p %26lt; 0.001). The significantly lower rate in the LAL group than the LAS group was caused by bacterial resistance to LVFX. %26lt;br%26gt;The findings suggest that triple therapy with PPI, AMPC, and STFX for one week would be an effective standard third-line eradication regimen for H. pylori in Japan.

• 出版日期2013-10
• 单位中国医学科学院肿瘤医院