title: Irsogladine maleate for the treatment of recurrent aphthous stomatitis in hepatitis C virus patients on pegylated-interferon and ribavirin: a pilot study.
abstract: OBJECTIVE
  Aphthous stomatitis is one of the adverse effects associated with interferon (IFN) that forces dose reduction of IFN and there is no established therapy. This study was aimed to investigate whether irsogladine maleate, which enhances the functions of intercellular communication through the gap junctions, is effective for the treatment of aphthous stomatitis developed in hepatitis C virus (HCV) patients on pegylated-interferon (PEG-IFN) and ribavirin.
  
  
  METHODS
  Nineteen patients with HCV were treated with PEG-IFN and ribavirin for 48 weeks. Ten out of 19 patients developed aphthous stomatitis during treatment with PEG-IFN and ribavirin. Within 1-2 weeks after development of aphthous stomatitis, 4 mg irsogladine maleate was orally administered daily to all patients and the therapeutic and adverse effects of irsogladine maleate were examined on every week. The degree of aphthous stomatitis was evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
  
  
  RESULTS
  Out of 10 patients, aphthous stomatitis was evaluated as grade 3 in three patients (30%) and grade 2 in seven patients (70%) by CTCAE. CTCAE grade was improved to 0 after 1 week in six patients, after 2 weeks in two patients, and after 3 weeks in two patients after the start of administration of irsogladine maleate. Aphthous stomatitis has not recurred in patients who had been on irsogladine maleate continuously during treatment of PEG-IFN and ribavirin.
  
  
  CONCLUSIONS
  Irsogladine maleate is effective for the treatment of aphthous stomatitis developing during PEG-IFN and ribavirin administration in HCV patients.
authors: Department of Gastroenterology, Kanazawa Medical University, Uchinada, Ishikawa, Japan.
authors: Nobuhiko
authors: N
authors: Hayashi
authors: Joseph
authors: J
authors: George
authors: Hisakazu
authors: H
authors: Shiroeda
authors: Takashi
authors: T
authors: Saito
authors: Nobuyuki
authors: N
authors: Toshikuni
authors: Mutsumi
authors: M
authors: Tsuchishima
authors: Tomiyasu
authors: T
authors: Arisawa
authors: Mikihiro
authors: M
authors: Tsutsumi
mesh_terms: D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000009:adverse effects* / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects* / Q000627:therapeutic use; D013281:Stomatitis, Aphthous / Q000139:chemically induced* / Q000188:drug therapy*; D014227:Triazines / Q000627:therapeutic use*
chemical_list: D000897:Anti-Ulcer Agents; D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D014227:Triazines; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a; C041836:irsogladine