title: Multi-center randomized controlled study to establish the standard third-line regimen for Helicobacter pylori eradication in Japan.
abstract: BACKGROUND
  The present study sought to establish a standard third-line eradication regimen for Helicobacter pylori in Japan.
  
  
  METHODS
  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.
  
  
  RESULTS
  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 < 0.05) and the LAL group (43.1 %; p < 0.001). The significantly lower rate in the LAL group than the LAS group was caused by bacterial resistance to LVFX.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Hasama-machi, Yuhu, Oita, 879-5593, Japan, murakam@oita-u.ac.jp.
authors.forename: Kazunari
authors.initials: K
authors.lastname: Murakami
authors.forename: Takahisa
authors.initials: T
authors.lastname: Furuta
authors.forename: Takashi
authors.initials: T
authors.lastname: Ando
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nakajima
authors.forename: Yoshikatsu
authors.initials: Y
authors.lastname: Inui
authors.forename: Tadayuki
authors.initials: T
authors.lastname: Oshima
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Tomita
authors.forename: Katsuhiro
authors.initials: K
authors.lastname: Mabe
authors.forename: Makoto
authors.initials: M
authors.lastname: Sasaki
authors.forename: Takanori
authors.initials: T
authors.lastname: Suganuma
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Nomura
authors.forename: Kiichi
authors.initials: K
authors.lastname: Satoh
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Hori
authors.forename: Syuuji
authors.initials: S
authors.lastname: Inoue
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tomokane
authors.forename: Mineo
authors.initials: M
authors.lastname: Kudo
authors.forename: Tomoki
authors.initials: T
authors.lastname: Inaba
authors.forename: Susumu
authors.initials: S
authors.lastname: Take
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Ohkusa
authors.forename: Shojiro
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Shigeaki
authors.initials: S
authors.lastname: Mizuno
authors.forename: Toshiro
authors.initials: T
authors.lastname: Kamoshida
authors.forename: Kenji
authors.initials: K
authors.lastname: Amagai
authors.forename: Junichi
authors.initials: J
authors.lastname: Iwamoto
authors.forename: Jun
authors.initials: J
authors.lastname: Miwa
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kodama
authors.forename: Tadayoshi
authors.initials: T
authors.lastname: Okimoto
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Kato
authors.forename: Masahiro
authors.initials: M
authors.lastname: Asaka
mesh_terms: D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D007564:Japan; D064747:Lansoprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D064704:Levofloxacin / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D024841:Fluoroquinolones; D064747:Lansoprazole; D064704:Levofloxacin; D000658:Amoxicillin; C076246:sitafloxacin