title: Safety of One-week, First-line, Standard Triple Therapy for Helicobacter pylori Eradication in a Japanese Population.
abstract: BACKGROUND
  Standard triple therapy with the proton pump inhibitors, clarithromycin and amoxicillin for Helicobacter pylori infection is considered to be safe; however, the development of significant adverse events (AEs), such as skin rashes, has been reported.
  
  
  OBJECTIVE
  To reconfirm the safety of this treatment.
  
  
  METHODS
  This was a retrospective cohort study. After the exclusion of patients allergic to penicillin, 322 consecutive patients, consisting of 305 outpatients and 17 inpatients, had received the first-line eradication treatment with lansoprazole (30 mg), clarithromycin (200 mg), and amoxicillin (750 mg) twice daily for 7 days. Their medical charts were reviewed, and data were collected.
  
  
  RESULTS
  Three patients discontinued the treatment because of the development of a skin rash, mild diarrhea, and heat sensation, respectively. The main AE observed was mild diarrhea in 50 patients. One patient had frequent diarrhea, but it was readily resolved by a probiotic treatment. On the second or third day after the conclusion of the treatment, a skin rash also occurred in six patients (2%). Two of these patients and one patient who discontinued the treatment were administered steroids as outpatients. They recovered within 1 month.
  
  
  CONCLUSIONS
  Most AEs that developed were mild, except for some cases of a rash. Rashes developed in spite of the exclusion of penicillin-allergic patients and mainly after the completion of the one-week treatment. As a consequence of little previous exposure to penicillin in the Japanese population, the development of delayed rashes after this exclusion may represent first sensitization to penicillin.
authors.affiliation: Department of Intestinal Inflammation Research, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya 663-8501,Japan.
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Hori
authors.affiliation: Department of Intestinal Inflammation Research, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501,Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Takagawa
authors.affiliation: Department of Intestinal Inflammation Research, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501,Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Hida
authors.affiliation: Department of Intestinal Inflammation Research, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501,Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Nakamura
mesh_terms: D006801:Humans; D008297:Male; D016481:Helicobacter Infections / Q000188:drug therapy; D005260:Female; D012189:Retrospective Studies; D008875:Middle Aged; D016480:Helicobacter pylori / Q000187:drug effects; D017291:Clarithromycin / Q000009:adverse effects / Q000008:administration & dosage / Q000627:therapeutic use; D000658:Amoxicillin / Q000009:adverse effects / Q000008:administration & dosage / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000008:administration & dosage / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000008:administration & dosage / Q000627:therapeutic use; D000368:Aged; D000328:Adult; D007564:Japan / Q000453:epidemiology; D064747:Lansoprazole / Q000009:adverse effects / Q000008:administration & dosage; D015331:Cohort Studies; D005076:Exanthema / Q000139:chemically induced; D003967:Diarrhea / Q000139:chemically induced; D000095225:East Asian People
chemical_list: D017291:Clarithromycin; D000658:Amoxicillin; D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole
keywords: Adverse event; Helicobacter pylori; amoxicillin; eradication rate; eradication treatment; penicillin; skin rash; standard
  triple therapy.