Ｐｒｕｌｉｆｌｏｘａｃｉｎ錠の市販後調査成績

• 河野 仁

  明治製菓株式会社信頼性保証センター市販後安全管理部

• 川又 さおり

  明治製菓株式会社信頼性保証センター市販後安全管理部

• 佐藤 吉和

  明治製菓株式会社信頼性保証センター市販後安全管理部

書誌事項

タイトル別名

• Postmarketing study of prulifloxacin tablets

抄録

Prulifloxacin (PUFX, Sword^®Tablets 100), an oral quinolone antibiotic, was approved for marketing on October 8, 2002.In the 3 years from January 2004 to 2007, we studied practical use in compliance with new Good Postmarketing Surveillance Practices (GPMSP).<BR>Of 4, 034 cases collected from 539 medical institutes nationwide, we evaluated 3, 076 for safety and 2, 881 for clinical efficacy, with the following results:<BR>1) The incidence of adverse drug reactions, 1.01% (31 cases/3, 076 cases), was lower than that in clinical studies before marketing approval, 9.20% (270 cases/2, 936 cases). The most frequently observed adverse drug reaction was diarrhea, at 0.33% (10 cases/3, 076 cases). No serious adverse reaction was observed.<BR>2) Clinical efficacy in each infection was from 932-100%, in each disease 90% or more excluding pneumonia, and results were equivalent to those in studies before marketing approval.

収録刊行物

• 日本化学療法学会雑誌

  日本化学療法学会雑誌 56 (3), 317-329, 2008

  公益社団法人 日本化学療法学会

キーワード

• prulifloxacin
• post-marketing surveillance
• safety
• efficacy

詳細情報

• CRID: 1390001206287289984
• NII論文ID: 10021192633
• NII書誌ID: AN10472127
• DOI: 10.11250/chemotherapy1995.56.317
• ISSN: 18845886
• ISSN: 13407007
• Web Site: https://search.jamas.or.jp/link/ui/2008280199
• 本文言語コード: ja
• データソース種別:
  • JaLC
  • CiNii Articles
• 抄録ライセンスフラグ: 使用不可